Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
2000 mg/kg bw: undiluted and 300 mg/kg bw: solution
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw in 6 females and 2000 mg/kg bw in 3 females
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
300 mg/kg bw: 2/6 animals died on study day 1 or delayed on study day 6
2000mg/kg bw: 3/3 animals were found dead within 1 hour after the administration
Clinical signs:
300mg/kg bw: impaired general state, dyspnoea, piloerection, reduced feces
2000 mg/kg bw: poor general state, impaired general state, gasping, staggering, respiration noises
Gross pathology:
2000mg/kg bw: lung: dark red spotted discoloration in all lobes; liver: dark red spotted discoloration; stomach: clear liquid content; glandular stomach: extended bleeding; small intestine: intensive red discoloration and red discoloration of content

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the median lethal dose of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.
Executive summary:

In an acute oral toxicity study performed according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item 4,4'-Diamino-3,3',5,5'-tetramethyldicyclohexylmethane (undiluted or preparations in olive oil Ph./Eu.) were administered to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner.

Under the conditions of this study the median lethal dose of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.