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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to guideline (84/449/EEC) with GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EEC (Gazette of the European Community, No. L 251, of 19 Sept, 1984, page 96)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Desmodur VP PU 1806
- Substance type: reddish liquid
- Physical state: 99.96%
- Expiration date of the lot/batch: 01 Nov 1990
- Storage condition of test material: 4 °C, under N2

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males 8 weeks and females 10 weeks
- Mean body weight at study initiation: males 184 g and females 167 g
- Fasting period before study: About 16 hours before and up to 4 hours after application
- Housing: groups of 5 per cage
- Diet (e.g. ad libitum): standard diet Altromin 1324 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
DOSAGE PREPARATION
The substance was dissolved in Peanut oil on a magnetic stirrer at room temperature. It was administered at a constant application volume of 10 ml/kg bw. The test substance was formulated in the application medium immediately before administration.
Doses:
2000 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: mortality and clinical signs were observed several times on the day of administration and twice daily thereafter. Animals were weighed before administration and weekly thereafter.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities were observed
Clinical signs:
All animals had increased salivation 30 min after application. One hr after application, all animals were free of clinical signs.
Body weight:
The body-weight development was not affected
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion