Registration Dossier

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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
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)
• incrustations
• incrustations including the whole application area
Body weight:
The mean body weights of the male and female animals did not adequately increase during the first post-exposure observation week but increased during the second week. Probably to the skin reactions these effects were seen in the animals.
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.