Cyclohexanamine, 4,4'-methylenebis[2,6-dimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study conducted according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine

EC Number:

634-657-5

Cas Number:

65962-45-0

Molecular formula:

C17H34N2

IUPAC Name:

4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Doses:

2000mg/kg bw

No. of animals per sex per dose:

5

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. The following test item-related local effects were recorded during the course of the study: • very slight to severe erythema (grade 1 to 4) • very slight to slight edema (grade 1 to 2)

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi- occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. Under the conditions of this study the median lethal dose (LD₅₀) of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.