Dodecan-5-olide

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value 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:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00099 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the given test chemical. The study concluded that LD50 value 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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study report

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

The aim of this study was to assess the toxicity potential of given test chemical after single oral administration in rats and an observation period of 14 days.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8- 10 weeks at the time of dosing. Healthy young adult animals were used for the study.
- Weight at study initiation: Minimum: 135 g Maximum: 152 g (Individual body weights were within ± 5% prior to treatment after overnight fasting)
- Fasting period before study: The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum.
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet, ad libitum
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:Animal nos. 1-3 were acclimatized for 5 days and 4-6 for 10 days.
- Identification:The animals were marked temporarily on tail, permanently on toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number, experimental start and completion date.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.30°C Maximum: 23.20°C
- Humidity (%): Minimum: 48.70 % Maximum: 64.20 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: 28 april 2014 to 23rd june 2014

Route of administration:

oral: unspecified

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage):10 ml/kg body weight.
- Justification for choice of vehicle: Corn oil was selected as a vehicle because test item was not soluble in the distilled water during solubility testing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg bw-06 Females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2. All the animals were subjected for external and internal observations.
- Other examinations performed: Clinical Observation - After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the surviving animals were observed once a day during the 14 day observation period.
Mortality - All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.

Statistics:

not specified

Preliminary study:

not specified

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no other details available

Mortality:

No mortality were observed throughout the experimentation period

Clinical signs:

other: At 2000 mg/kg, all the six animals were observed with normal clinical sign till day 14.

Gross pathology:

No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifies.

Other findings:

not specified

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

Sex: Female

Animal No.	Group/Dose (mg/kg)	Body weight (gram)			Body weight change (%)
	G1/2000	Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1		142	173	186	21.83	30.99
2		137	168	177	22.63	29.20
3		135	156	176	15.56	30.37
4		149	180	194	20.81	30.20
5		152	178	185	17.11	21.71
6		144	162	171	12.50	18.75

 

Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)

Sex: Female

Group/Dose (mg/kg)		Rats Body Weight (g)			Body weight changes (%)
		Day 0	Day 7	Day 14	0-7	0-14
G1/2000	Mean	14317	169.50	181.50	18.40	26.87
	SD	6.62	9.33	8.36	4.00	5.26
	n	6	6	6	6	6

Key: SD: Standard Deviation, n: Number of Animals

 

Table 3: Individual Animal Clinical Signs and Symptoms

 Sex: Female

Animal No.	Group/ Dose (mg/kg)	Hours (Day 0)
		1/2	1	2	3	4
1	G1/ 2000	1	1	1	1	1
2		1	1	1	1	1
3		1	1	1	1	1
4		1	1	1	1	1
5		1	1	1	1	1
6		1	1	1	1	1

Animal No.	Group/ Dose (mg/kg)	Days post dosing
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	G1/ 2000	1	1	1	1	1	1	1	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1	1	1	1	1	1	1	1
3		1	1	1	1	1	1	1	1	1	1	1	1	1	1
4		1	1	1	1	1	1	1	1	1	1	1	1	1	1
5		1	1	1	1	1	1	1	1	1	1	1	1	1	1
6		1	1	1	1	1	1	1	1	1	1	1	1	1	1

Table 4: Individual Animal Mortality Record

 Sex: Female

Animal No.	Group/ Dose (mg/kg)	Day of Observation (Day 0 to 14)
		Morning Observations	Evening Observations
1	G1/ 2000	No mortality and morbidity	No mortality and morbidity
2		No mortality and morbidity	No mortality and morbidity
3		No mortality and morbidity	No mortality and morbidity
4		No mortality and morbidity	No mortality and morbidity
5		No mortality and morbidity	No mortality and morbidity
6		No mortality and morbidity	No mortality and morbidity

Table 5: Gross Necropsy Observation

 Sex: Female                                                                                                                                        

Animal No.	Group/ Dose (mg/kg)	Mode of Death	Gross Observation
			External	Internal
1	G1/ 2000	Terminal sacrifice	No abnormality detected	No abnormality detected
2		Terminal sacrifice	No abnormality detected	No abnormality detected
3		Terminal sacrifice	No abnormality detected	No abnormality detected
4		Terminal sacrifice	No abnormality detected	No abnormality detected
5		Terminal sacrifice	No abnormality detected	No abnormality detected
6		Terminal sacrifice	No abnormality detected	No abnormality detected

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 value of test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibits acute oral toxicity and thus not classified.

Executive summary:

Acute oral toxicity study of the given test chemical was conducted as per OECD No. 423 in rats. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality were observed. Hence further dosing was stopped. Body weight were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of animals treated with 2000 mg/kg body weight were observed with gain on day 7 and 14, when compare to day 0. At 2000 mg/kg all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathlogical examination were seen in all six animals treated with 2000 mg.kg body weight during terminal sacrifice.

Under the conditions of this, the acute oral LD50 value of test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibits acute oral toxicity and thus not classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 1 and from study report.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Clinical signs:

other:

Endpoint conclusion

Quality of whole database:

Waiver

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study report

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The objective of the study was to assess the dermal toxicity of the given test chemical after single dose application by dermal route in rats and an observation period of 14 days.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Healthy young adult animals were used for the study
- Weight at study initiation: Male:Minimum: 216 g and Maximum: 278 g
(Prior to Treatment)Female:Minimum: 200 g and Maximum: 217 g
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet, ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:All animals were acclimatized to the test conditions for 7 days prior to administration of the test item.
- Identification:During Acclimatization, animals were temporarily marked by permanent marker, on their tails. After acclimatization, the animals were marked by toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, sex, animal number, experimental start and completion date.
- Randomization:Animals were selected manually. No computer generated randomization program was used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.90 °C Maximum: 23.10 °C
- Humidity (%): Minimum: 53.30% Maximum: 66.50%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From:April 28, 2014 To: June 26, 2014

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The test item was applied uniformly over clipped dorsal area of skin
- % coverage: Approx. 10% of body surface area
- Type of wrap if used: The test item was held in contact with the skin with a porous gauze dressing and non-irritating tape throughout a 24-hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test item was removed by using distilled water.
- Time after start of exposure:24-hour

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 (Five per sex)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observation - After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality - Animals were observed twice daily for any mortality during the experimental period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14.
Local Signs/Skin Reactions - All animals were observed once daily during days 1-14 (in common with clinical signs).
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.

Statistics:

No statistical analysis was performed since the study was terminated with limit test.

Preliminary study:

Limit Test - Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight. Since no test item related mortality was observed, the study was terminated with limit test only.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.

Clinical signs:

other: All the animals were observed with normal clinical signs throughout the experimental period.

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Other findings:

not specified

Table 1: Individual Animal Body Weight (g) and Body Weight Changes(%)

Dose: 2000 mg/ kg body weight                                                                                                         

Aminal No.	Sex	Dose volume (ml)	Body Weight (gram)			Body Weight Changes (%)
			Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1	Male	0.55	269	277	294	2.97	9.29
2		0.57	278	288	304	3.60	9.35
3		1.44	216	215	232	-0.46	7.41
4		0.55	268	259	273	-3.36	1.87
5		0.54	263	287	321	9.13	22.05
6	Female	0.42	207	211	225	1.93	8.70
7		0.45	217	222	243	2.30	11.98
8		0.42	203	213	226	4.93	11.33
9		0.41	201	208	232	3.48	15.42
10		0.41	200	207	227	3.50	13.50

Key: *= Based on density and day 0 body weight

Table 2: Individual Animal Clinical Signs and Symptoms

 

Dose:2000 mg/kg body weight

Animal No.	Sex	Hour(s) - Day 0				Day
		1	2	3	4	1	2	3	4	5	6	7
1	Male	1	1	1	1	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1	1	1	1	1
3		1	1	1	1	1	1	1	1	1	1	1
4		1	1	1	1	1	1	1	1	1	1	1
5		1	1	1	1	1	1	1	1	1	1	1
6	Female	1	1	1	1	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1	1	1	1	1
8		1	1	1	1	1	1	1	1	1	1	1
9		1	1	1	1	1	1	1	1	1	1	1
10		1	1	1	1	1	1	1	1	1	1	1

 

Animal No.	Sex	Day
		8	9	10	11	12	13	14
1	Male	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1
3		1	1	1	1	1	1	1
4		1	1	1	1	1	1	1
5		1	1	1	1	1	1	1
6	Female	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1
8		1	1	1	1	1	1	1
9		1	1	1	1	1	1	1
10		1	1	1	1	1	1	1

Keys: 1 = Normal

Table 4: Summary of Animal Body Weight (g) and Body Weight Changes (%)

 Dose: 2000 mg/kg body weight

Sex		Body Weight (gram)			Body Weight Changes (%)
		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
Male	Mean	258.80	265.20	284.80	2.38	9.99
	SD	24.53	30.38	34.24	4.70	7.40
	n	5	5	5	5	5
Female	Mean	205.60	212.20	230.60	3.23	12.19
	SD	6.91	5.97	7.44	1.18	2.51
	n	5	5	5	5	5

Keys: SD= Standard deviation, n = Number of animals

Table 5: Gross Necropsy Observation

 

 Dose: 2000 mg/kg body weight                                               Mode of Death: Terminal Sacrifice

Animal No.	Sex	Gross Observation
		External	Internal
1	Male	No abnormalities detected	No abnormalities detected
2		No abnormalities detected	No abnormalities detected
3		No abnormalities detected	No abnormalities detected
4		No abnormalities detected	No abnormalities detected
5		No abnormalities detected	No abnormalities detected
6	Female	No abnormalities detected	No abnormalities detected
7		No abnormalities detected	No abnormalities detected
8		No abnormalities detected	No abnormalities detected
9		No abnormalities detected	No abnormalities detected
10		No abnormalities detected	No abnormalities detected

Interpretation of results:

other: Not classified

Conclusions:

Under the conditions of the study, acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Executive summary:

Acute dermal toxicity study of the given test chemical was conducted as per OECD No.402 in Wistar rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, an amount of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. All the animals were observed with normal clinical signs throughout the experimental period. In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. Mean body weight of both males and females were observed with increase on day 7 and 14, as compare to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Under the conditions of the study, acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 1 and from study report.

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 the given test chemical. The studies are summarized as below –

 

The reported study was mentioned in study report and conducted to determine the acute oral toxicity dose for the given test chemical as per OECD No. 423 in rats. Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality were observed. Hence further dosing was stopped. Body weight were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of animals treated with 2000 mg/kg body weight were observed with gain on day 7 and 14, when compare to day 0. At 2000 mg/kg all the six animals were observed with normal clinical sign till day 14. No external and internal gross pathlogical examination was seen in all six animals treated with 2000 mg.kg body weight during terminal sacrifice. Under the conditions of this, the acute oral LD50 value of test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute oral toxicity and thus not classified.

 

The above study report is supported with another study mentioned in different publications and authoritative database for the given test chemical. The acute oral toxicity study was conducted in rats at the dose concentration of 5000 mg/kg bw. Animals were observed for mortality. No mortality was observed at 5000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >5000 mg/kg bw, when rats was treated with the given test chemical via oral gavage route.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value 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:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00099 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

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 rats and rabbits for test chemical. The studies are summarized as below -

 

The reported study was mentioned in study report and conducted to determine acute dermal toxicity dose for the given test chemical as per OECD No.402 in Wistar rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, an amount of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after applicationon test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. All the animals were observed with normal clinical signs throughout the experimental period. In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. Mean body weight of both males and females were observed with increase on day 7 and 14, as compare to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of the study, acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

 

Another study mentioned in publication and authoritative database, was carried out to determine the acute dermal toxicity dose by using the given test chemical in rabbits at the dose concentration of 5000 mg/kg bw. Animals were observed for mortality. No mortality was observed at 5000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.

 

Thus, based on the above summarised studies for test chemical, it can be concluded that LD50 value 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.

 

Justification for classification or non-classification

Based on the above studies for the test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.