Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted between 14 March 1979 and 12 April 1979.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Reference: E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods Drugs and Cosmetics (The Association of Food and Druk Officials of the United States, 1975), pp. 17-25.
Deviations:
no
GLP compliance:
no
Remarks:
study was conducted pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: No data (suitable licensed dealer)- Age at study initiation: 6 to 8 weeks - Weight at study initiation: 200-300 gram- Fasting period before study: 18 hours- Housing: Galvanized cages with indirect bedding- Diet (e.g. ad libitum): Ad libitum - Water (e.g. ad libitum): Ad libitum- Acclimation period: 2 days ENVIRONMENTAL CONDITIONS - Temperature (°C): Temperature controlled room - Humidity (%): No information available - Air changes (per hr): No information available - Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE - No information available MAXIMUM DOSE VOLUME APPLIED: 5 g/kg bw
Doses:
5 g/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: At 1 hour, 3, 6 and 24 hours and thereafter once daily.- Necropsy of survivors performed: Yes, gross necropsy- Other examinations performed: Body weights (day 1 and day 14).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Two animals died on Day 2 and one animal died on day 4 after administration of the test item.
Clinical signs:
In all animals moisted and matted hair was observed on the first day. Slight depression was seen in one surviving animal. In two of the three animals that died depression and severe depression was noted.
Body weight:
All surviving animals had an increased bodyweight after the observation period on day 14.
Gross pathology:
No gross changes were observed in surviving animals and the animals that died, although these were partially cannibalized.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
Under the conditions of this test, the acute oral LD50 was determined to be >5000 mg/kg bw. Based on this result, the test material does not need be classified for acute oral toxicity in accordance with the criteria outlined in EU CLP (1272/2008/EC and its amendments).
Executive summary:

In this study (comparable to OECD TG 401), 1 group of 10 rats (5 males and 5 females) was administered the test item at a dose level of 5000 mg/kg bw. Animals were observed for 14 days. Three of the 10 test animals died during the observation period. Observed clinical signs included moisted and matted hair and slight to severe depression (including animals that died). The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg.