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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Diaminotoluene, propoxylated, purity >99%
TERCAROL* 5903, Supplier: The Dow Chemical Company
- Molecular weight: Mn = 340 g/mole

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
12 weeks of age. Bodyweight: 195-2019 g.
Housed in gorups fo three wiht free access to drinking water and food throughout the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
2000 mg/kg bw single dose
No. of animals per sex per dose:
6 femalse in groups of three treated with 2000 mg/kg bw single dose.
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
1 aniaml was found dead 4 hours after dosing.
Clinical signs:
Three animals in hunched posture and occasional body tremors.
Body weight:
The surviving animals showed expected body weight gains.
Gross pathology:
For the animal that died the following abnormalities were noted: red lung, dark liver, dark kidneys, and epithelial sloughing of the gastric muscoa and non-glandular region of the stomach.
No abnormalities were noted at necropsy of the animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 of > 2500 mg/kg bw was determined following the acute LD50 Class method (highest does tested 2000 mg/kg bw).