Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Apr - 06 May 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Hoe WISKf (SPF71)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 198 - 218g (mean: 205.1g)
- Fasting period before study: 2 - 16 h prior to gavage
- Housing: Macrolon group cages with softwood granulate
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
suspension
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 g in 100 mL
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
according to Spector (Handbook of Toxicology)

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 100 mg/kg bw
Based on:
act. ingr.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality
Clinical signs:
145 after dosage: apathy, orange feces (until day 3).
Clinical signs disappeared 170 min after dosage.
Body weight:
No effects observed
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in female rats was determined >5000 mg/kg. The substance is not classifiable according to CLP criteria.