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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:
key study
Study period:
1985-12-04 to1986-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
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:
TEST ANIMALS
- Source:
Interfauna U. K. Limited, Wyton, Huntingdon
- Age at study initiation:
5 - 8 weeks
- Weight at study initiation:
males: 115 - 123 g; females: 122 - 140 g
- Fasting period before study:
overnight before dosing and approx. two hours after dosing
- Housing:
The animals were housed in polypropylene cages with sawdust bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 23 °C
- Humidity: 45 - 70 %
- Air changes: approx. 15 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4.21 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1 and 4 hours after dosing, thereafter once daily for 14 days
- Frequency of weighing: on the day of treatment (day 0) and days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortality was observed (0/10).
Clinical signs:
AII treated animals showed hunched posture and piloerection one and four hours after treatment. AII animals recovered and were normal on day one and throughout the study period.
Body weight:
Normal bodyweight gains were recorded during the study period.
Gross pathology:
All animals necropsied at the end of the study period were unremarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD59) of the test item to the rat was found to be greater than 5000 mg/kg bw.
Executive summary:

The study was designed to assess the acute oral toxicity of the test material in the rat. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute 0ral Toxicity". The test system was chosen because the rat has been shown to be a suitable model for this type of study and is recommended in the test method. The results of the study are believed to be of value in predicting the likely toxicity of the test material to man. Five male and female Sprague-Dawly rats were orally administered the pure test item via gavage. Observations one and four hours after treatment revealed clinical signs of hunched posture and piloerection. These signs were reversible within one day. No mortality was observed within the 14 days observation period. No gross pathological findings were observed in the treated animals. Based on the results of this study, the LD50 of the test item is considered to be greater than 5000 mg/kg bw in the rat.