Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
mostly due to reduced reporting in times before GLP, limited data to test substance, read across substance

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:
yes
Remarks:
The application volume was not calculated by the individual weight, but by the mean weight per sex
Principles of method if other than guideline:
Standardized test method (BASF-Test)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Acclimatization in the animal care unit for at least 1 week.
Age of the animals at the beginning of the study: about 12 weeks
Type of cage: Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
No. of animals per cage: 5
Animal identification: Identification of groups (5 animals) using cage cards
Room temperature: 20 - 26°C
Humidity: 45 - 75%
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Drinking water: Demineralized water each workday, tap water on holidays; ad libitum
Diet: Ssniff R; SSNIFF, Versuchstierdiaeten, Soest, Germany
Fasting period: The animals are given no feed 16 hours before administration, but water is available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous carboxymethyl cellulose and 1 - 2 drops of Cremophor EL
Details on oral exposure:
Aqueous formulation corresponds to the physiological medium.
Form of administration: suspension
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Weight check: Animals of comparable weight (+/- 10 g) in one cage; weighing of groups before administration, 2nd weighing on the 3rd day, 3rd weighing on the 7th day, 4th weighing on the 13th day after administration.
Signs and symptoms: Recording of signs and symptoms < 15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after administration of the test substance and then once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Pathology: Withdrawal of food 16 hours before sacrifice with C02; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible.
Statistics:
-

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality, no toxicity observed.
Mortality:
none
Clinical signs:
1 day after treatment: yellow feces
Body weight:
Mean Body weigt:
Males: At the beginning of the study: 220 g, after 3 days: 262 g, after 7 days: 290 g, after 13 days: 312 g.
Females: At the beginning of the study: 190 g, after 3 days: 217 g, after 7 days: 228 g, after 13 days: 233 g.
No abnormality in body weight gain was detected.
Gross pathology:
Sacrificed animals: organs: no abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met