Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The robust study summary was received from the ECHA in accordance with Article 25(3) (the "12-year-rule"). ECHA helpdesk enquiry number: 06-0000024807-62-0000. The full study report is not available. The test was performed according to Directive 67/548/EEC requirements and GLP.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
402-130-7
EC Name:
-
Cas Number:
106246-33-7
Molecular formula:
C21 H28 Cl2 N2
IUPAC Name:
4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
other: 1% aqueous methyl cellulose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
For 9 animals: no clinical signs of toxicity.
One animal died on day 8. This animal was emaciated and had been observed to have hunched posture and stained fur on days 6 and 7.
Gross pathology:
Effects on organs:
None in survivors.
Dark lungs and pale, enlarged liver with dark and yellow patches in animal which died.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU