Registration Dossier

Administrative data

Description of key information

In five available oral acute toxicity studies in the rat the LD50 values ranged from 1400 to 2600 mg/kg bw.

A reliable acute inhalation toxicity study in the rat resulted in a 4-hour LC50 value of >3.6 mg/L.

Three weight-of-evidence acute dermal toxicity studies in the rabbit are available; two were producing LD50 values in the range from 1000 to 2000 mg/kg bw, one resulted in a LD50 value in the range from 501 to 794 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restricitions: no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
GLP compliance:
not specified
Test type:
standard acute method
Specific details on test material used for the study:
OTHER SPECIFICS: recovered cyclohexanol (01-14-76)
Species:
rat
Strain:
other: Sprague-Dawley Albino rats
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not reported
Doses:
1260, 1580, 2000, 2510 mg/kg bw
No. of animals per sex per dose:
5 animals/dose:1260 mg/kg bw: 3 M/2F1580 mg/kg bw: 2 M/3F2000 mg/kg bw: 3M/2F2510 mg/kg bw :3 M/2F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 060 mg/kg bw
95% CL:
1 910 - 2 220
Mortality:
Death occured between 2 hours and 24 hours
- 1260 mg/kg bw: 0/5
- 1580 mg/kg bw: 1/5 (1M/0F)
- 2000 mg/kg bw: 2/5 (1M/1F)
- 2510 mg/kg bw :5/5 (3M/2F)
Clinical signs:
Reduced appetite and activity (one to two days in survivors), rapid increasing weakness, collapse and death.
Gross pathology:
Gross autopsy of decedents revealed lung hyperemia, areas of slight liver discolouration and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
In this in vivo study on Sprague-Dawley Albino rats the resulting LD50 of 2060 mg/kg bw indicates that the test material has an acute oral toxicity of Category 5 based on GHS criteria.
Executive summary:

This acute oral toxicity study was performed in a manner similar to OECD guideline 401 (Acute Oral Toxicity) prior to introduction of GLP compliance.

Four doses (1260, 1580, 2000 and 2510 mg/kg bw) of undiluted test material were administered to groups of five Sprague-Dawley Albino rats (male and female) per dose. Animals were observed for 14 days. Mortalities were observed from 1580 mg/kg bw onwards. Clinical signs included reduced appetite and activity (one to two days in survivors), rapid increasing weakness, collapse and death. Gross autopsy of decedents revealed lung hyperemia, areas of slight liver discolouration and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy.

Under the conditions of this study, the single oral LD50 for rats was reported at 2060 mg/kg bw with a 95% confidence limit of 1910 – 2220 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restrictions: no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not reported
Doses:
794, 1000, 1260, 1580 mg/kg bw
No. of animals per sex per dose:
5 animals/ dose:
- 794 mg/kg bw: 2M/3F
- 1000 mg/kg bw: 3M/2F
- 1260 mg/kg bw: 2M/3F
- 1580 mg/kg bw: 3M/2F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
95% CL:
1 260 - 1 550
Mortality:
794 mg/kg bw: 0/5
1000 mg/kg bw: 0/5
1260 mg/kg bw: 1/5 (1M/0F)
1580 mg/kg bw : 4/5 (2M/2F)
All deaths occured within one to two days.
Clinical signs:
Weight loss (in survivors after one day, weight gain in seven days), increasing weakness, ocular discharge, collapse and death.
Gross pathology:
Gross autopsy of decedents revealed hemorrhagic lungs, liver hyperemia and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In this in vivo study on Sprague-Dawley rats the resulting LD50 value of 1400 mg/kg bw indicates that the test material has an acute oral toxicity of Category 4 based on GHS criteria.
Executive summary:

This acute oral toxicity study was performed in a manner similar to OECD guideline 401 (Acute Oral Toxicity). GLP compliance was not reported.

Four doses (794, 1000, 1260, and 1580 mg/kg bw) of undiluted test material were administered to groups of five Sprague-Dawley rats (male and female) per dose. Animals were observed for 14 days. Mortalities were observed at 1260 and 1580 mg/kg bw. Clinical signs included weight loss (in survivors after one day, weight gain after seven days), increasing weakness, ocular discharge, collapse and death. Gross autopsy of decedents revealed hemorrhagic lungs, liver hyperemia and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy.

Under the conditions of this study, the single oral LD50 for rats was reported as 1400 mg/kg bw with a 95% confidence limit of 1260 – 1550 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restrictions: no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
GLP compliance:
not specified
Test type:
standard acute method
Specific details on test material used for the study:
OTHER SPECIFICS: crude cyclohexanol
Species:
rat
Strain:
other: Sprague-Dawley Albino
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: not reported
Doses:
1000; 1260; 1580; 2000; 2510; 3160 mg/kg bw
No. of animals per sex per dose:
5animals/dose;
- 1000 mg/kg bw: 2M/3F
- 1260 mg/kg bw: 3M/2F
- 1580 mg/kg bw: 2M/3F
- 2000 mg/kg bw: 3M/2F
- 2510 mg/kg bw: 2M/3F
- 3160 mg/kg bw: 3M/2F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: not reported
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs (no details on frequency of check-ups), body weight (body weights were measured at initiation. Frequency of bodyweight measurement thereafter were not mentioned.)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 550 mg/kg bw
95% CL:
1 390 - 1 710
Mortality:
Mortality occured within 1-2 days post application whereby the largest part of the animals died on day one.
Number of deaths:
- 1000 mg/kg bw: 0/5
- 1260 mg/kg bw: 0/5
- 1580 mg/kg bw: 3/5 (1/2 M and 2/3 F)
- 2000 mg/kg bw: 5/5 (3/3 M and 2/2 F)
- 2510 mg/kg bw: 5/5 (2/2 M and 3/3 F)
- 3160 mg/kg bw: 5/5 (3/3 M and 2/2 F)
Clinical signs:
- Weight loss (one to two days in survivors), increasing weakness, ocular discharge, salivation, collapse and death.
Body weight:
- Weight loss was noted but details of the individual animal weight gain were not reported.
Gross pathology:
- Animals that died prematurely: Hemorrhagic lungs, areas of liver discolouration and acute gastrointestinal inflammation.
- Survivors: At the end of the observation period (14 d), the visceral of the surviving animals were normal.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In this in vivo study on Sprague-Dawley Albino rats the resuling LD50 value of 1550 mg/kg bw indicates that the test material has an acute oral toxicity of Category 4 based on GHS criteria.
Executive summary:

This acute oral toxicity study was performed in a manner similar to OECD guideline 401 (Acute Oral Toxicity). GLP compliance was not reported.

Six doses (1000, 1260, 1580, 2000, 2510 and 3160 mg/kg bw) of undiluted test material were administered to groups of five Sprague-Dawley Albino rats (male and female) per dose. Animals were observed for 14 days. Mortalities were observed from 1580 mg/kg bw onwards. Clinical signs included weight loss (one to two days in survivors), increasing weakness, ocular discharge, salivation, collapse and death. Gross autopsy of decedents revealed hemorrhagic lungs, areas of liver discolouration and acute gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy.

Under the conditions of this study, the single oral LD50 for rats was reported at 1550 mg/kg bw with a 95% confidence limit of 1390 – 1710 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 400 mg/kg bw
Quality of whole database:
Three studies on the acute oral toxicity of cyclohexanol are available, which were conducted to protocols broadly comparable to the OECD testing guideline with some restrictions. The results from these studies are used in a weight-of-evidence approach to derive an appropriate classification of cyclohexanol for acute oral toxicity.

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:
comparable to guideline study with acceptable restrictions
Remarks:
Restrictions: no GLP
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
traditional method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Source: MUS RATTUS Brunnthal
- average weight at study initiation: 178g (male), 176 g (female)
- Feeding: Herilan MRH der Firma H. ECGERSMANN, Rinteln/Weser; ad libitum
- Water: tap water; ad libitum
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
Aerosol was generated using "Dauerinfusionspumpe" UNITA (B, Braun), and "Zweistoffdüse" (Rhema)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
method: gas chromatography
Duration of exposure:
4 h
Concentrations:
Nominal/target concentration: 7.5 mg/L
Analytical concentration: 3.63 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14d
- Control animals: air
- Frequency of observations : daily
- Frequency of weighing: before begin, on day 7 and at termination
- Necropsy of survivors performed: yes
Statistics:
A modification of the Wittig Binomial test (Wittig H: Matematische Statistik 1974, S 32-35)
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 3.6 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
no deaths occured
Clinical signs:
other: Ruffled fur coat was noticed after exposure. Symptoms dissappeared after 1 day.
Body weight:
TREATED ANIMALS
- In comparison to the air controls, body weight gain was not influenced. Mean body weight on day 7 was 221g (male) and 198g (female). On day 14, body weights were 250 g (male), and 209g (females). CONTROLS: Day 0: 180g (male); 173g (female)
Day 7: 224 g (male); 194 (female)
Day 14: 261g (male); 207g (female)
Gross pathology:
No adverse gross pathological findings
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LC50 under the conditions of the test was >3.6 mg/L leading to a classification into class Acute Tox. 4.
Executive summary:

This acute inhalation toxicity test was performed similar to OECD Guideline 403. GLP compliance was not reported. A group of 20 Sprague-Dawley rats (10 male and 10 female) was subjected to a nominal vapour concentrated airstream of the test material for four hours. Animals were observed for 14 days. No mortalities were observed. Clinical signs included ruffled fur coat, which disappeared after one day. No abnormalities were detected in the organs of survivors. Under the conditions of the study the LC50 for rats was reported to be >3.6 mg/L.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
3 600 mg/m³
Quality of whole database:
One study on the acute inhalation toxicity of cyclohexanol is available, which was conducted to protocols broadly comparable to the OECD testing guideline with some restrictions. The result from this study is used to derive an appropriate classification of cyclohexanol for acute inhalation toxicity.

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restrictions: no data on substance purity, prior to GLP, limited reporting on study design and methods, number of animals, animals were of different sex
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not reported
- Purity: recovered cyclohexanol
Species:
rabbit
Strain:
other: New Zealand Albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- not reported

ENVIRONMENTAL CONDITIONS
- not reported
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: not reported
- % coverage: not reported
Duration of exposure:
24 h
Doses:
501, 794, 1260, 2000, 3160, 5010 mg/kg bw
No. of animals per sex per dose:
1 animal per dose, alternating male and female 501 (1m/0f), 794 (0m/1f), 1260 (1m/0f)2000 (0m/1f), 3160 (1m/0f), 5010 (0m/1f)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 260 mg/kg bw
Based on:
test mat.
Mortality:
501 mg/kg bw: 0/1, 794 mg/kg bw: 0/1, 1260 mg/kg bw: 0/1, 2000 mg/kg bw: 1/1 (0m/1f), 3160 mg/kg bw: 1/1 (1m/0f), 5010 mg/kg bw: 1/1 (0m/1f)
Clinical signs:
- reduced appetite and activity (survivors: one to three days)
- increasing weakness
- collaps
Body weight:
not documented
Gross pathology:
- Animals that died prematurely: lung hyperemia, liver discoloration, kidneys darkened, slightly enlarged gall bladder, gastrointestinal inflammation.
- Survivors: At the end of the observation period (14 d), the viscera of the surviving animals appeared normal.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In this in vivo study on New Zealand Albino rabbits the resulting LD50 >1260 mg/kg bw indicates that the test material has an acute dermal toxicity, leading to classification into Acute Tox. Category 4 based on GHS criteria.
Executive summary:

This acute dermal toxicity study was performed in a manner similar to OECD guideline 402 (Acute Dermal Toxicity). GLP compliance was not reported.

Six doses (501, 794, 1260, 2000, 3160 and 5010 mg/kg bw) of undiluted test material were administered dermally to New Zealand albino rabbits, one animal per dose (male and female alternating). Animals were observed for 14 days. Mortalities were observed at 2000 mg/kg bw and above and occurred within one day. Clinical signs included reduced appetite and activity (in survivors one to three days), increasing weakness, collapse and death. Gross autopsy of decedents revealed lung hyperemia, liver discolouration, darkened kidneys, slightly enlarged gall bladder, and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy. Under the conditions of this study, the single dermal LD50 for rabbits was reported >1260 mg/kg bw.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restrictions: no data on substance purity, prior to GLP, limited reporting on study design and methods, number of animals, animals were of different sex
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not reported
- Purity: not reported
Species:
rabbit
Strain:
other: New Zealand Albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- not reported

ENVIRONMENTAL CONDITIONS
- not reported
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: not reported
- % coverage: not reported

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
316, 501, 794, 1260, 2000, 3160, 5010 mg/kg bw
No. of animals per sex per dose:
1 animal per dose, alternating male and female 316 (1m/0f), 501 (0m/1f), 794 (1m/0f), 1260 (0m/1f), 2000 (1m/0f), 3160 (0m/1f), 5010 (1m/0f)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 501 - < 794 mg/kg bw
Based on:
test mat.
Mortality:
316 mg/kg bw: 0/1, 501 mg/kg bw: 0/1, 794 mg/kg bw: 1/1 (1m/0f), 1260 mg/kg bw: 0/1 (0m/1f), 2000 mg/kg bw: 1/1 (1m/0f), 3160 mg/kg bw: 1/1 (0m/1f), 5010 mg/kg bw: 1/1 (1m/0f)
Clinical signs:
- weight loss (survivors: two days, weight gain in seven days)
- increasing weakness
- collaps
Body weight:
not documented
Gross pathology:
- Animals that died prematurely: lung hyperemia, liver and spleen discoloration, enlarged gall bladder, kidneys darkened, gastrointestinal inflammation.
- Survivors: At the end of the observation period (14 d), the viscera of the surviving animals appeared normal.
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
In this in vivo study on New Zealand Albino rabbits the resulting LD50 in the range from 501 to 794 mg/kg bw indicates that the test material has an acute dermal toxicity, leading to a classification into Acute Tox. Category 3 based on GHS criteria.
Executive summary:

This acute dermal toxicity study was performed in a manner similar to OECD guideline 402 (Acute Dermal Toxicity). GLP compliance was not reported.

Seven doses (316, 501, 794, 1260, 2000, 3160 and 5010 mg/kg bw) of undiluted test material were administered dermally to New Zealand albino rabbits, one animal per dose (male and female alternating). Animals were observed for 14 days. Mortalities were observed at 794 mg/kg bw and at all doses from 2000 mg/kg bw and above. No mortality was observed at 1260 mg/kg bw. Clinical signs included weight loss (in survivors up to two days, weight gain in seven days), increasing weakness, collapse and death. Gross autopsy of decedents revealed lung hyperemia, liver and spleen discolouration, enlarged gall bladder, kidneys darkened and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy. Under the conditions of this study, the single dermal LD50 for rabbits was reported between 501 and 794 mg/kg bw.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
restrictions: no data on substance purity, prior to GLP, limited reporting on study design and methods, number of animals, animals were of different sex
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no data on substance purity, prior to GLP, limited reporting on study design and methods, animals were of different sex
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not reported
- Purity: crude
Species:
rabbit
Strain:
other: New Zealand Albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- not reported

ENVIRONMENTAL CONDITIONS
- not reported
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: not reported
- % coverage: not reported
Duration of exposure:
24 h
Doses:
631, 1000, 1580, 5010 mg/kg bw
No. of animals per sex per dose:
1 animal per dose, alternating male and female 631 (0m/1f), 1000 (1m/0f), 1580 (0m/1f), 5010 (1m/0f)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Mortality:
631 mg/kg bw: 0/1, 1000 mg/kg bw: 0/1, 1580 mg/kg bw: 1/1 (0m/1f), 5010 mg/kg bw: 1/1 (1m/0f)
Clinical signs:
- weight loss (survivors: two to four days)
- increasing weakness
- collaps
Body weight:
not documented
Gross pathology:
- Animals that died prematurely: hemorrhagic areas of the lungs, liver and spleen discolouration, enlarged gall bladder, kidneys darkened, gastrointestinal inflammation.
- Survivors: At the end of the observation period (14 d), the viscera of the surviving animals appeared normal.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In this in vivo study on New Zealand Albino rabbits the resulting LD50 of >1000 mg/kg bw indicates that the test material has an acute dermal toxicity, leading to classification into Acute Tox. Category 4 based on GHS criteria.
Executive summary:

This acute dermal toxicity study was performed in a manner similar to OECD guideline 402 (Acute Dermal Toxicity). GLP compliance was not reported.

Four doses (631, 1000, 1580, and 5010 mg/kg bw) of undiluted test material were administered dermally to New Zealand albino rabbits, one animal per dose (male and female alternating). Animals were observed for 14 days. Mortalities were observed at 1580 mg/kg bw and above. Clinical signs included weight loss (in survivors two to four days), increasing weakness, collapse and death. Death occurred within one day. Gross autopsy of decedents revealed hemorrhagic areas of the lungs, liver and spleen discolouration, enlarged gall bladder and gastrointestinal inflammation. Viscera of survivors appeared normal after 14 days at necropsy. Under the conditions of this study, the single dermal LD50 for rabbits was reported >1000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
1 250 mg/kg bw
Quality of whole database:
Three studies on the acute dermal toxicity of cyclohexanol are available, which were conducted to protocols broadly comparable to the OECD testing guideline with some restrictions. The results from these studies are used in a weight-of-evidence approach to derive an appropriate classification of cyclohexanol for acute dermal toxicity.

Additional information

Justification for classification or non-classification

The available studies on the acute toxicity of cyclohexanol via the oral, inhalation and dermal routes are considered to be reliable (with restrictions) or can be used in a weight-of-evidence approach for the purpose of classification and labelling according to Regulation (EC) No 1272/2008, as amended by Commission Regulation (EU) No 286/2011. The data on the acute oral and inhalation toxicity support the legal classification. Furthermore, the data on dermal toxicity indicate that a classification of cyclohexanol for acute dermal toxicity is also warranted.

Based on the available, experimental results, cyclohexanol is to be classified into the following categories:

  • Acute oral toxicity: Acute Tox. Cat. 4
  • Acute inhalation toxicity: Acute Tox. Cat. 4
  • Acute dermal toxicity: Acute Tox. Cat. 4