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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:
16 Feb - 06 Mar 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 120 - 139 g; females: 122 - 138 g
- Housing: animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 39 - 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:
Preliminary study: 25, 200, 2000 and 5000 mg/kg bw
Main study: 2000 mg/kg bw
No. of animals per sex per dose:
Preliminary study: 1
Main study: 5
Control animals:
no
Details on study design:
Preliminary study:
- Duration of observation period following administration: 5 days
- Frequency of observations: Animals were observed 1 and 4 hours after dosing and then daily for 5 days.
- Necropsy of survivors performed: no

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths and evidence of overt toxicity 1 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:
The female rat dosed with 5000 mg/kg bw died on day 1. All other animals survived until the end of the study. From this mortality data the oral LD50 was considered to be approximately 5000 mg/kg bw and a dose level of 2000 mg/kg bw was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed until the end of the study.
Clinical signs:
Common signs of toxicity noted on the first day were hunched posture, lethargy, piloerection, decreased respiratory rate and ataxia.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study.

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:
In this acute oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.