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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:
Feb - Mar 1983
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:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 wks (male), 14 wks (female)
- Weight at study initiation: 173 - 200 g (male), 150 - 168 g (female)
- Fasting period before study: 16 h
- Housing: Makrolon Type III cages (group of 5 animals)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.5
- Humidity (%): 55 - 65
- Light/darkness (h): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.0 mL/kg bw
Doses:
5000, 3100 mg/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 and weighing: daily twice, weighing at day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/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:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
20% females and 20% males at high concentration within 8 hours after administration
0% at low concentration
Clinical signs:
5000 mg/kg bw: poor general condition, rough coat
3100 mg/kg bw: no clinical signs
Body weight:
no effects observed
Gross pathology:
no effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in male/female rats was determined to be >5000 mg/kg bw (>2000 mg/kg bw act. ingr.). The substance is not classifiable according to CLP criteria.