Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
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:
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:
other: 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.