Registration Dossier

Administrative data

Description of key information

LD50 oral, male rat = 3250 mg/kg bw
LD50 dermal, rabbits - 2430 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.
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
Species:
rat
Strain:
Sherman
Sex:
male
Route of administration:
oral: gavage
Vehicle:
water
Doses:
four dosages in a geometrical series
No. of animals per sex per dose:
5
Sex:
male
Dose descriptor:
LD50
Effect level:
3 250 mg/kg bw

RS-Freetext:
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) for 3,3,5-Trimethylcyclohexanol was obtained in a published study from 1949. The study is taken as key study for the asssessment of 2,3,6-Trimethycyclohexanol.
Endpoint conclusion
Dose descriptor:
LD50
Value:
3 250 mg/kg bw

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.
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
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

RS-Freetext:
LD50 reported as 2.8 ml/kg bw

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
A dermal study on 3,3,5-Trimethylcyclohexanol with rabbits applying the test substance in four doses yields a LD50 reported as 2.8 ml/kg bw.
Endpoint conclusion
Dose descriptor:
LD50
Value:
2 430 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
No acute oral toxicity study on the substance 2,3,6-Trimethylcyclohexanol itself was available.
Therefore, a read-across from 3,3,5-Trimethylcyclohexanol was performed to address this endpoint, based on chemical structure similarity. In an acute oral toxicity study on the read-across substance, an LD50 for male rats of 3250 mg/kg (Confidence Interval: 2740 - 3860 mg/kg bw) was obtained (publication from Smyth H.F. ; Carpenter C.P.; Weil C.S., 1949).

Justification for selection of acute toxicity – dermal endpoint
No acute dermal toxicity study on the substance 2,3,6-Trimethylcyclohexanol itself was available.
Therefore, a read-across from 3,3,5-Trimethylcyclohexanol was performed to address this endpoint, based on chemical structure similarity. A dermal study with rabbits applying the test substance in four doses yields a LD50 reported as 2.8 ml/kg bw (publication from Smyth H.F. ; Carpenter C.P.; Weil C.S., 1949).

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.