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Description of key information

Acute toxicity: oral: LD50 = 3250 mg/kg bw (WoE).
Acute toxicity: dermal: LD50 = 2430 mg/kg bw ( WoE).

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
Study period:
1949
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from handbook or collection of data, important study details and confidence interval given, considered reliable.
Qualifier:
according to
Guideline:
other: see Principles of method if other than guideline
Principles of method if other than guideline:
Method: other: For details not reported in this publication see previous publications in J. Ind. Hyg. Toxicol. 26, 269-273 (1944) and J. Ind. Hyg. Toxicol. 30, 63-68 (1948).
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sherman
Sex:
male
Route of administration:
oral: gavage
Vehicle:
water
Doses:
four doses in a geometrical series
No. of animals per sex per dose:
5
Sex:
male
Dose descriptor:
LD50
Effect level:
3 250 mg/kg bw

Confidence interval ("fiducial range"): 2740 - 3860 mg/kg bw

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
An acute oral toxicity LD50 for male rats of 3250 mg/kg (CI 2740 - 3860 mg/kg bw) was obtained in a published study from 1949. The study is taken as key study for the asssessment.
Executive summary:

The LD50 for acute oral toxicity in male rats is 3250 mg/kg (CI 2740 - 3860 mg/kg bw) as published in the study from Smyth et al. (1949) for the substance 3,3,5-Trimethylcyclohexanol . The study is taken as key study for the asssessment.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 250 mg/kg bw
Quality of whole database:
Reliable with restrictions (Klimisch Code 2)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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
Study period:
1949
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from handbook or collection of data, important study details and confidence interval given, considered reliable.
Qualifier:
according to
Guideline:
other: see Principles of method if other than guideline
Principles of method if other than guideline:
Method: other: For details not reported in this publication see previous publications in J. Ind. Hyg. Toxicol. 26, 269-273 (1944) and J. Ind. Hyg. Toxicol. 30, 63-68 (1948).
GLP compliance:
no
Test type:
standard acute method
Species:
rabbit
Type of coverage:
occlusive
Vehicle:
other: none (i.e. undiluted test substance)
Doses:
four dosages in a geometrical series
No. of animals per sex per dose:
5
Dose descriptor:
LD50
Effect level:
2 430 mg/kg bw

LD50 reported as 2.8 ml/kg bw

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
A dermal study with rabbits applying the test substance in four doses yields a LD50 reported as 2.8 ml/kg bw. The study was taken as key study for 3,3,5-trimethylcyclohexanole.
Executive summary:

A LD50 was reported for acute dermal toxicity as 2.8 ml/kg bw for the test substance in rabbits. The study was taken as key study for 3,3,5-trimethylcyclohexanol.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 430 mg/kg bw
Quality of whole database:
Reliable with restrictions (Klimisch Code 2)

Additional information

An acute oral toxicity LD50 for male rats of 3250 mg/kg (CI 2740 - 3860 mg/kg bw) was obtained in a published study from 1949. The study is taken as key study for the asssessment.

A dermal study with rabbits applying the test substance in four doses yields a LD50 reported as 2.8 ml/kg bw. The study was taken as key study for 3,3,5-trimethylcyclohexanole.


Justification for selection of acute toxicity – oral endpoint
Data from handbook or collection of data, important study details and confidence interval given, considered reliable.

Justification for selection of acute toxicity – dermal endpoint
Data from handbook or collection of data, important study details and confidence interval given, considered reliable.

Justification for classification or non-classification

Based on the available acute toxicity results in rodents the substance does not need to be classified for acute toxicity under EC 1272/2008 or the dangerous substance directive 548/67/EEC.