Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1971
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:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Deviations: no details on test material, limited details on test animals and environmental conditions.
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: Young albino rats
- Weight at study initiation: 150 - 208 g
- Fasting period before study: 16 hours
- Housing: The animals were housed in stock cages. Following administration of the test substance, the rats were individually housed in suspended, wire-mesh cages.
- Diet: Free access to standard laboratory rat diet
- Water: Free access to water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
No data.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
Doses:
4.6, 6.8, 10.2 and 15.4 g/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Initial and final body weights as well as all mortalities and/or reactions displayed were recorded.
- Necropsy of survivors performed: A necropsy was conducted on any animal which died during the study as well as on all surviving animals sacrificed at the end of the 14 days.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 800 mg/kg bw
Based on:
test mat.
Mortality:
All animals died at the dose levels of 10200 (within 2 days after dosing) and 15400 mg/kg bw (within 1 day after dosing) and all animals survived at the dose levels of 4600 and 6800 mg/kg bw.
Clinical signs:
Hypoactivity, ruffed fur and muscular weakness was observed among all animals (starting after dosing, and disappearing after max. 4 days). At the dose levels 6800, 10200 and 15400 mg/kg also lacrimation was observed and at the dose levels 10200 and 15400 mg/kg also prostration was observed.
Body weight:
All surviving animals showed a normal body weight increase.
Gross pathology:
Necropsy of the animals that died revealed hemorrhages in the gastrointestinal tracts. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study with rats, performed equivalent to OECD 401 guidelines, an LD50 of >6800 mg/kg bw was determined.
Executive summary:

The test item was tested in an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline.

All animals died at the dose levels of 10200 and 15400 mg/kg bw and all animals survived at the dose levels of 4600 and 6800 mg/kg bw. Hypoactivity, ruffed fur, muscular weakness, lacrimation and prostration was observed among the animals. All surviving animals showed a normal body weight increase. Necropsy of the animals that died revealed hemorrhages in the gastrointestinal tracts. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period. Based on the results, an LD50 of >6800 mg/kg bw was determined.