Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan/Feb 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Disperse Brown 4

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: ca. 12 weeks old
- Housing: 5 animals were kept in per cage (V-II-A-steel cages)
- Fasting period before study: 16 hours before treatment animals received no diet
- Diet (e.g. ad libitum): SSNIFF R from SSNIFF Versuchstierdiaeten, Soest, Germany; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 -75
- Air changes (per hr): not identified
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: <15 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5 hours after application. Afterwards once per day the clinical signs were recorded and twice per day mortality was checked.
- Frequency of weighing: before application, and on days 3, 7 and 13 after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis [Finney D.J., 1971; Cambridge University Press Vol. 3]

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 465 mg/kg bw
Based on:
act. ingr.
Clinical signs:
No effects
Body weight:
No effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in rats was found at 16900 mg/kg bw corresponding to 3465 mg/kg bw act. ingr. The substance is not classifiable according to CLP criteria.