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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
24 Jan - 9 Feb 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
/ Substance tested only at 5% solution

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 Feb 1987
Principles of method if other than guideline:
study performed based on E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 17 - 25
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: suitably licensed dealer, no further details available
- Age at study initiation: 6 - 9 weeks
- Weight at study initiation: 190 - 220 g
- Fasting period before study: 18 h
- Diet: commercial food, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24 Jan To: 9 Feb 1983

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/ kg bw
No. of animals per sex per dose:
5 females/ 5 males per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 3, 6 and 24 h after dosing and then daily for 14 days in total
- Body weight: animals were weighed before and after the treatment period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ weights, gross changes
Statistics:
no statistics were performed

Results and discussion

Preliminary study:
no preliminary study performed
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One out of five females died on day 6.
Clinical signs:
One out of five males showed mucoid diarrhea after 1, 3 and 6 h, another 2 males after 6 h.
Body weight:
All animals showed normal body weight gain during the observation period.
Gross pathology:
No abnormal gross findings were identified in the examined organs.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified