Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: 

Acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >4750 mg/kg bw. The study concluded that the LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation toxicity: 

Acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats, mice and guinea pigs for the test chemical. The LC50 value is >12 ppm (>12000 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity.

Acute Dermal toxicity: 

Acute Dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >2600 mg/kg bw. The study concluded that the LD50 is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal.
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Acute oral toxicity of the given test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation (if other than submission substance): C(CCCCCCO)CCCCCC
- InChl (if other than submission substance): 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
Fasting period before study: 3-4 hours prior to study
Housing: Group - housed
Diet (e.g. ad libitum):ad libitum
Water (e.g. ad libitum): ad libitum
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Concentration in vehicle: 0.032 to 10.0ml/kgbw
MAXIMUM DOSE VOLUME APPLIED: 10.0 ml/kgbw
CLASS METHOD (if applicable)
Rationale for the selection of the starting dose:
A dosing schedule employing half log
separations and ranging from 0.032 to 10.0 ml/kg body weight was generally used.
The results have been converted to weight
units by means of the specific gravity.
Doses:
0.032 to 10.0 ml/kg bw
No. of animals per sex per dose:
groups of 5 male rats
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days (or other?): 7 to 14 days
Frequency of observations and weighing: Observations for signs of toxicity were made frequently on the day of administration and daily thereafter for a period of 7 to 14 days
Necropsy of survivors performed: yes/no: Yes
Statistics:
The mortality data were analyzed by the moving average of Horn or the method of Litchfield and Wilcoxon. The results have been converted to weight units by means of the specific gravity.
Preliminary study:
No data
Sex:
male
Dose descriptor:
LD50
Effect level:
4 750 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% Mortality observed at 4750 mg/kg bw
Mortality:
50% Mortality observed at 4750 mg/kg bw.
Clinical signs:
The principal signs of effect were central nervous system depression and labored respiration. The depression included inactivity, ataxia, limb sprawling, depressed righting and placement reflexes, prostration, and coma.
Body weight:
No data
Gross pathology:
Gross necropsy revealed some evidence of gastrointestinal irritation.
Other findings:
No data

Table: Acute Oral toxicity of Alcohols

Alcohol

Carbon No.

LD50 gm/kg

Tridecyl

13

4.75a

 

a- LD50 value was estimated, since mortality pattern was not suitable for analysis.

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be 4750 mg/kg bw, when groups of 5 male Sprague-Dawley rats were treated with the given test chemical via oral gavage route.
Executive summary:

Acute oral toxicity study was conducted by using test chemical in groups of 5 male Sprague-Dawley rats at the concentration ranging from 0.032 to 10.0 ml/kg body weight. The given test chemical was dissolved in a corn oil suspension or in undiluted form. The animals had been fasted for 3 to 4 hours prior to the study and were group-housed, with water and feed freely available after dosing. Observations for signs of toxicity were made frequently on the day of administration and daily thereafter for a period of 7 to 14 days. Gross necropsy examinations were performed on all animals that died or were killed. The mortality data were analyzed by the moving average of Horn or the method of Litchfield and Wilcoxon. The results have been converted to weight units by means of the specific gravity. LD50 was estimated, since mortality pattern was not suitable for analysis. 50% Mortality observed at 4750 mg/kg bw.The principal signs of effect were central nervous system depression and labored respiration. The depression included inactivity, ataxia, limb sprawling, depressed righting and placement reflexes, prostration, and coma.Gross necropsy revealed some evidence of gastrointestinal irritation. Therefore, the acute oral toxicity dose (LD50) was considered to be 4750 mg/kg bw, when groups of 5 male Sprague-Dawley rats were treated with the test chemical via oral gavage route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 750 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer-reviewed journal.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication.
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute Inhalation toxicity of the given test chemical in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- IUPAC Name: 1-Tridecanol
- InChI: 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Smiles: C(CCCCCCO)CCCCCC
- Molecular formula:C13H28O
- Molecular weight:200.3632 g/mole
- Substance type:Organic
- Physical state:White solid
Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals and environmental conditions:
Housing: group-housed by species during and after the exposures
Diet (e.g. ad libitum):ad libitum, post- exposure
Water (e.g. ad libitum): ad libitum, post-exposure
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remark on MMAD/GSD:
not specified
Details on inhalation exposure:
MAXIMUM DOSE VOLUME APPLIED: 12ppm
DOSAGE PREPARATION (if unusual): The exposures were at atmospheres nearly saturated with vapors of the alcohol. The generators were fritted-disk glass bubblers
containing a measured amount of alcohol through which all air entering the chamber was passed.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Remarks on duration:
not specified
Concentrations:
12ppm = 12mg/kg
No. of animals per sex per dose:
Groups of ten rats (sex not mentioned)
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 24 hours
Necropsy of survivors performed: yes/no: Yes, Gross necropsies were performed on the animals that died and at the end of the holding period.
Other examinations performed: Observations were made for mortality, signs of toxic effect, and body weight changes.
Statistics:
Dose reported is calculated from sample loss and airflow
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 12 mg/L air
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: No deaths were seen in the 6 hour vapor inhalation studies.
Mortality:
No deaths were seen in the 6 hour vapor inhalation studies.
Clinical signs:
other: Signs of systemic toxicity were not pronounced and consisted primarily of central nervous system depression. Local irritation was observed to a very less extent in all the test animals. This irritation involved the mucous membranes of the eyes, nose, thro
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

 

Table: Acute Toxicity of Alcohol Vapor (6 hour exposure)

 

Alcohol

 

Concentration

Signs

Irritation

Systemic Effects

Tridecyl alcohol

12 ppm

Slight

None

 

Interpretation of results:
other: Not classified
Conclusions:
Acute inhalation toxicity dose (LC50) was considered to be >12 ppm (>12000 mg/m3), when rats were exposed with the given test chemical via inhalation route for 6 hours.
Executive summary:

Acute inhalation toxicity study was conducted by using test chemical in group of 10 Wistar rats at the concentration of 12 ppm for 6 hours of exposure. The exposures were at atmospheres nearly saturated with vapors of the alcohol. The generators were fritted-disk glass bubblers containing a measured amount of alcohol through which all air entering the chamber was passed.Observations were made for mortality, signs of toxic effect, and body weight changes.Gross necropsies were performed on the animals that died and at the end of the holding period.Dose reported is calculated from sample loss and airflow. No deaths were seen in the 6 hour vapor inhalation studies.Signs of systemic toxicity were not pronounced and consisted primarily of central nervous system depression. Local irritation was observed to a very less extent in all the test animals. This irritation involved the mucous membranes of the eyes, nose, throat, and respiratory passages and was manifest as blinking, lacrimation, preening, nasal discharge, salivation, gasping, and chewing movements. Therefore, the acute inhalation toxicity dose (LC50) was considered to be >12 ppm (>12000 mg/m3), when rats were exposed with test chemical via inhalation route for 6 hours.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
12 000 mg/m³
Quality of whole database:
Data is Klimisch 2 and from publication.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal
Qualifier:
according to
Guideline:
other: refer below principle
Principles of method if other than guideline:
Acute Dermal toxicity of test chemical in rabbit.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- IUPAC Name: 1-Tridecanol
- InChI: 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Smiles: C(CCCCCCO)CCCCCC
- Molecular formula:C13H28O
- Molecular weight:200.3632 g/mole
- Substance type:Organic
Species:
rabbit
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
Housing: The animals were housed individually
Diet (e.g. ad libitum):ad libitum
Water (e.g. ad libitum): ad libitum
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: the closely clipped, intact abdominal skin
- Type of wrap if used: The exposed area was covered with an occlusive binding of dental damming
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin.
- Time after start of exposure:24 hour
Duration of exposure:
24 hours
Doses:
0.10, 0.316, 1.00, and 3.16 ml/kg were administered volumetrically.
No. of animals per sex per dose:
groups of 4 (sex not mentioned)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Observations for signs of toxicity were made frequently on the day of application and once daily afterward for a total of 7 days.
Necropsy of survivors performed: yes/no: Yes, Gross necropsies were performed at the end of the experiments.
Statistics:
The results have been converted to gravimetric expressions by use of the specific gravity.
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Dose reported is the highest dose tested
Mortality:
No Mortality observed at 2600 mg/kg bw.
Clinical signs:
No signs of toxicity observed
Body weight:
No data
Gross pathology:
No data
Other findings:
On observation of the binders after 24 hours of skin contact, percutaneous absorption was evident with all the alcohols even though the median lethal dose was not achieved.

 

Table: Acute dermal toxicity of alcohols

Alcohol

LD50 (gm/kg)

Signs

Tridecyl

>2.6

None

 

Interpretation of results:
other: Not classified
Conclusions:
Acute dermal toxicity dose (LD50) was considered to be >2600 mg/kg bw, when groups of 4 albino rabbits were treated with test chemical by dermal application occlusively to the closely clipped, intact abdominal skin for 24 hours.
Executive summary:

Acute dermal toxicity study was conducted by using test chemical in groups of 4 albino rabbits at the dose concentration of 0.10, 0.316, 1.00, and 3.16 ml/kg bw administered volumetrically. The animals were housed individually with feed and water freely available. No mechanical restraints were used.The test chemical was applied full-strength to the closely clipped, intact abdominal skin of albino rabbits. The exposed area was covered with an occlusive binding of dental damming for 24 hours. After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin. Observations for signs of toxicity were made frequently on the day of application and once daily afterward for a total of 7 days. Gross necropsies were performed at the end of the experiments. The results have been converted to gravimetric expressions by use of the specific gravity. No Mortality observed at 2600 mg/kg bw. No signs of toxicity observed. On observation of the binders after 24 hours of skin contact, percutaneous absorption was evident with the chemical even though the median lethal dose was not achieved. Therefore, LD50 was considered to be >2600 mg/kg bw, when groups of 4 albino rabbits were treated with test chemical by dermal application occlusively to the closely clipped, intact abdominal skin for 24 hours.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 600 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer reviewed journal.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

1. Acute oral toxicity study was conducted by using test chemical in groups of 5 male Sprague-Dawley rats at the concentration ranging from 0.032 to 10.0 ml/kg body weight. The given test chemical was dissolved in a corn oil suspension or in undiluted form. The animals had been fasted for 3 to 4 hours prior to the study and were group-housed, with water and feed freely available after dosing. Observations for signs of toxicity were made frequently on the day of administration and daily thereafter for a period of 7 to 14 days. Gross necropsy examinations were performed on all animals that died or were killed. The mortality data were analyzed by the moving average of Horn or the method of Litchfield and Wilcoxon. The results have been converted to weight units by means of the specific gravity. LD50 was estimated, since mortality pattern was not suitable for analysis. 50% Mortality observed at 4750 mg/kg bw.The principal signs of effect were central nervous system depression and labored respiration. The depression included inactivity, ataxia, limb sprawling, depressed righting and placement reflexes, prostration, and coma.Gross necropsy revealed some evidence of gastrointestinal irritation. Therefore, the acute oral toxicity dose (LD50) was considered to be 4750 mg/kg bw, when groups of 5 male Sprague-Dawley rats were treated with the test chemical via oral gavage route.

2. Acute Oral toxicity study was conducted by using test chemical in groups of 5 male Carworth-Wistar rats at the concentration range of 12300 - 23900 mg/kg bw. The given test chemical was administered either by undiluted material or a solution in water or corn oil or as an agar suspension. Doses were given in a logarithmic series differing by a factor of 2. The animals were observed for mortality for 14 days. The most probable LD50 value and its fiducial range are estimated by the method of Thompson, using the Tables of Weil. The figures in parentheses show limits of ± 1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality.50% mortality was observed at 17200 mg/kg bw. Therefore, the acute oral toxicity dose (LD50) was considered to be 17200 mg/kg bw, with 95% confidence limit of 12300 – 23900 mg bw, when groups of 5 male Carworth –Wistar rats were treated with given test chemical via oral gavage route.

3. Acute Oral toxicity study was conducted by using the test chemical in rats at the dose concentration of 17200 mg/kg bw. 50% mortality was observed at 17200 mg/kg bw. Therefore, LD50 was considered to be 17200 mg/kg bw, when rats were treated with the given test chemical via oral route.

4. Acute Oral toxicity study was conducted by using test chemical in 10 fasted Harlan Wistar rats at oral dose 7 ml/kg of a formulation containing 2.0% Cetyl Alcohol. Animals were observed for clinical signs of toxicity. No mortality was observed at 7000 mg/kg bw. No signs of toxicity were noted. Therefore, LD50 was considered to be >7000 mg/kg bw, when 10 male Harlan Wistar rats were treated with the test chemical via oral gavage route.

5. Acute Oral toxicity study of test chemical was conducted according to the Protocol stated in Title 16 Part 1500.3 (b)(G)(i)(A) of the Code of Federal Regulations in a group of 10 or more laboratory white rats at the dose concentration of 5000 mg/kg bw. The given test chemical was prepared with the moisturizing lotion containing 0.8% Myristyl Alcohol and administered via oral route. No mortality was observed at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg bw, when group of 10 or more laboratory white rats were treated with the test chemical via oral route.

6. Acute oral toxicity study was conducted by using given test chemical in groups of 5 male Sprague-Dawley rats at the concentration ranging from 0.032 to 10.0 ml/kg body weight. The given test chemical was dissolved in a corn oil suspension or in undiluted form. The animals had been fasted for 3 to 4 hours prior to the study and were group-housed, with water and feed freely available after dosing. Observations for signs of toxicity were made frequently on the day of administration and daily thereafter for a period of 7 to 14 days. Gross necropsy examinations were performed on all animals that died or were killed. The mortality data were analyzed by the moving average of Horn or the method of Litchfield and Wilcoxon. The results have been converted to weight units by means of the specific gravity.50% Mortality observed at 4720 mg/kg bw.The principal signs of effect were central nervous system depression and labored respiration. The depression included inactivity, ataxia, limb sprawling, depressed righting and placement reflexes, prostration, and coma.Gross necropsy revealed some evidence of gastrointestinal irritation. Therefore, the acute oral toxicity dose (LD50) was considered to be 4720 mg/kg bw, when groups of 5 male Sprague-Dawley rats were treated with the test chemical via oral gavage route.

7. The study was designed and conducted to determine the acute oral toxicity profile of the given test chemical in Sprague Dawley rats. Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item(Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of  2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from  300 mg/kg and 2000 mg/kg dose groups. The acute oral LD50 was considered to be >2000 mg/kg bw, when female rats were treated with test chemical administered via oral route. Thus, it was concluded that the acute toxicity study of the given test chemical, when administered via oral route in Sprague Dawley rats falls into the “Not classified” criteria of CLP.

8. The reported study was designed and conducted to determine the acute oral toxicity profile of the given test chemical in Sprague Dawley rats. Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from  300 mg/kg and 2000 mg/kg dose groups. The acute oral toxicity dose LD50 was considered to be >2000 mg/kg bw, when female Sprague Dawley rats were treated with the given test chemical via oral route. Thus, it was concluded that the acute toxicity study of test chemical falls into the “Category Not classified” according to the criteria of CLP.

Thus, based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified as for acute oral toxicity.

Acute Inhalation Toxicity:

In different studies the given test chemical has been investigated for acute Inhalation toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats, mice and guinea pigs for the test chemical. The studies are summarized as below –

1. Acute inhalation toxicity study was conducted by using test chemical in group of 10 Wistar rats at the concentration of 12 ppm for 6 hours of exposure. The exposures were at atmospheres nearly saturated with vapors of the alcohol. The generators were fritted-disk glass bubblers containing a measured amount of alcohol through which all air entering the chamber was passed. Observations were made for mortality, signs of toxic effect, and body weight changes. Gross necropsies were performed on the animals that died and at the end of the holding period.Dose reported is calculated from sample loss and airflow. No deaths were seen in the 6 hour vapor inhalation studies.Signs of systemic toxicity were not pronounced and consisted primarily of central nervous system depression. Local irritation was observed to a very less extent in all the test animals. This irritation involved the mucous membranes of the eyes, nose, throat, and respiratory passages and was manifest as blinking, lacrimation, preening, nasal discharge, salivation, gasping, and chewing movements. Therefore, the acute inhalation toxicity dose (LC50) was considered to be >12 ppm (>12000 mg/m3), when rats were exposed with test chemical via inhalation route for 6 hours.

2. Acute inhalation toxicity study was conducted by using the given test chemical in group of 10 Swiss mice at the concentration of 12 ppm for 6 hours of exposure. The exposures were at atmospheres nearly saturated with vapors of the alcohol. The generators were fritted-disk glass bubblers containing a measured amount of alcohol through which all air entering the chamber was passed. Observations were made for mortality, signs of toxic effect, and body weight changes. Gross necropsies were performed on the animals that died and at the end of the holding period. Dose reported is calculated from sample loss and airflow. No deaths were seen in the 6 hour vapor inhalation studies. Signs of systemic toxicity were not pronounced and consisted primarily of central nervous system depression. Local irritation was observed to a very less extent in all the test animals. This irritation involved the mucous membranes of the eyes, nose, throat, and respiratory passages and was manifest as blinking, lacrimation, preening, nasal discharge, salivation, gasping, and chewing movements. Therefore, the acute inhalation toxicity dose (LC50) was considered to be >12 ppm (>12000 mg/m3), when mice were exposed with test chemical via inhalation route for 6 hours.

3. Acute inhalation toxicity study was conducted by using test chemical in group of 10 English Short Hair guinea pigs at the concentration of 12 ppm for 6 hours of exposure. The exposures were at atmospheres nearly saturated with vapors of the alcohol. The generators were fritted-disk glass bubblers containing a measured amount of alcohol through which all air entering the chamber was passed. Observations were made for mortality, signs of toxic effect, and body weight changes. Gross necropsies were performed on the animals that died and at the end of the holding period. Dose reported is calculated from sample loss and airflow. No deaths were seen in the 6 hour vapor inhalation studies. Signs of systemic toxicity were not pronounced and consisted primarily of central nervous system depression. Local irritation was observed to a very less extent in all the test animals. This irritation involved the mucous membranes of the eyes, nose, throat, and respiratory passages and was manifest as blinking, lacrimation, preening, nasal discharge, salivation, gasping, and chewing movements. Therefore, the acute inhalation toxicity dose (LC50) was considered to be >12 ppm (>12000 mg/m3), when guinea pigs were exposed with test chemical via inhalation route for 6 hours.

4. Acute Inhalation toxicity study was conducted by using test chemical in groups of 10 rats at a single 6-h exposure of vapors (26 ppm) under dynamic conditions, followed by a 24-h holding period, was reported. Necropsies were performed on the animals at the end of the holding period. Local irritation due to the alcohol vapor was slight and involved the mucous membranes of the eyes, nose, throat, and respiratory passages. There were no signs of systemic toxicity and no deaths were reported. Therefore, LC50 was considered to be >26 mg/L, when groups of 10 rats were treated with test chemical via inhalation by vapor.

5. Acute Inhalation toxicity study of test chemical was conducted in 10 young adult Albino Sprague-Dawley rats (average weight, 250 g) were exposed to an aerosol containing 3.0% Myristyl Alcohol. Exposures were conducted in a 0.038 m3 glass chamber and comprised 20 10 sec aerosol bursts (one burst every 3 min) during a 1-h period. Approximately 7.4 g of the test substance were delivered with each burst, and the average test substance concentration was approximately 192 mg/L of air. Following 10 min of exposure, ataxia and moderate nasal irritation were noted in all animals and persisted throughout the remainder of the exposure period. These reactions were also noted in all animals up to 4 h after their removal from the chamber. No deaths were reported. Therefore, LC50 was considered to be >192 mg/L air, when 10 young adult Albino Sprague-Dawley rats were exposed to test chemical via inhalation route.

6. Acute inhalation toxicity study was conducted by using test chemical in group of 10 Wistar rats at the concentration of 95 mg/L for 6 hours of exposure. The exposures were at atmospheres nearly saturated with vapors of the alcohol. The generators were fritted-disk glass bubblers containing a measured amount of alcohol through which all air entering the chamber was passed. Observations were made for mortality, signs of toxic effect, and body weight changes.Gross necropsies were performed on the animals that died and at the end of the holding period. Dose reported is calculated from sample loss and airflow. No deaths were seen in the 6 hour vapor inhalation studies. Signs of systemic toxicity were not pronounced and consisted primarily of central nervous system depression. Local irritation was observed to a very less extent in all the test animals. This irritation involved the mucous membranes of the eyes, nose, throat, and respiratory passages and was manifest as blinking, lacrimation, preening, nasal discharge, salivation, gasping, and chewing movements. Therefore, the acute inhalation toxicity dose (LC50) was considered to be >95 mg/L when rats were exposed with test chemical via inhalation route for 6 hours.

Thus, based on the above studies on test chemical, it can be concluded that LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity.

Acute Dermal toxicity:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rabbits and rats for the test chemical. The studies are summarized as below –

1. Acute dermal toxicity study was conducted by using test chemical in groups of 4 albino rabbits at the dose concentration of 0.10, 0.316, 1.00, and 3.16 ml/kg bw administered volumetrically. The animals were housed individually with feed and water freely available. No mechanical restraints were used. The test chemical was applied full-strength to the closely clipped, intact abdominal skin of albino rabbits. The exposed area was covered with an occlusive binding of dental damming for 24 hours. After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin. Observations for signs of toxicity were made frequently on the day of application and once daily afterward for a total of 7 days. Gross necropsies were performed at the end of the experiments. The results have been converted to gravimetric expressions by use of the specific gravity. No Mortality observed at 2600 mg/kg bw. No signs of toxicity observed. On observation of the binders after 24 hours of skin contact, percutaneous absorption was evident with the chemical even though the median lethal dose was not achieved. Therefore, LD50 was considered to be >2600 mg/kg bw, when groups of 4 albino rabbits were treated with test chemical by dermal application occlusively to the closely clipped, intact abdominal skin for 24 hours.

2. Acute Dermal toxicity study was conducted by using test chemical in Group 4 male New Zealand rabbits at the dose ranging from 2330-21400 mg/kg bw to the clipped skin. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. Penetration of rabbit skin is estimated by a technique closely akin to the one-day cuff method of Draize and associate. 50% mortality was observed at 7070 mg/kg bw. Therefore, LD50 was considered to be 7070 mg/kg bw, with 95% confidence limit of 2330-21400 mg/kg bw, when Group 4 male New Zealand rabbits were treated with test chemical by dermal application occlusively to the clipped skin.

3. Acute Dermal toxicity study was conducted by using test chemical in rabbits at the dose ranging from 5600 mg/kg bw. 50% mortality was observed at 5600 mg/kg bw. Therefore, LD50 was considered to be 5600 mg/kg bw, when rabbits were treated with test chemical by dermal application.

4. Acute Dermal toxicity study was conducted by using test chemical in 16 albino rabbits at the concentration of 0.10, 0.316, 1.00, and 3.16 ml/kg bw. The test chemical was applied full-strength to the clipped intact abdominal skin of rabbits. The animals were divided equally into 4 treatment groups: 0.10, 0.316, 1.00, and 3.16 ml/kg doses. Each exposed area was covered with an occlusive binding of dental damming that remained in place for 24 h. Observations for signs of toxicity were made for a total of 7 days post application. No mortality was observed at 2600 mg/kg bw. One of the 4 animals in the 3.16 ml/kg group had decreased activity and labored respiration. Therefore, LD50 was considered to be >2600 mg/kg bw, when 16 albino rabbits were treated with test chemical by dermal application occlusively to the clipped intact abdominal skin.

5. Acute dermal toxicity study was conducted by using test chemical in groups of 4 albino rabbits at the dose concentration of 0.10, 0.316, 1.00, and 3.16 ml/kg bw administered volumetrically. The animals were housed individually with feed and water freely available. No mechanical restraints were used. The test chemical was applied full-strength to the closely clipped, intact abdominal skin of albino rabbits. The exposed area was covered with an occlusive binding of dental damming for 24 hours. After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin. Observations for signs of toxicity were made frequently on the day of application and once daily afterward for a total of 7 days. Gross necropsies were performed at the end of the experiments. The results have been converted to gravimetric expressions by use of the specific gravity. No Mortality observed at 2600 mg/kg bw. No signs of toxicity observed. On observation of the binders after 24 hours of skin contact, percutaneous absorption was evident with the chemical even though the median lethal dose was not achieved. Therefore, LD50 was considered to be >2600 mg/kg bw, when groups of 4 albino rabbits were treated with test chemical by dermal application occlusively to the closely clipped, intact abdominal skin for 24 hours.

6. The reported study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

7. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

Thus, based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies on the given test chemical, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral and acute dermal toxicity; and LC50 value is >5 mg/L air for acute inhalation toxicity. Thus, comparing these values with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral, acute dermal and acute inhalation toxicity.