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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:
1990-09-06 to 1990-09-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Directive 84/449/EEC, September 19, 1984
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Strain: SPF-bred Wistar rats (strain Bor: WISW (SPF Cpb)
- Age at study initiation: young-adult. At the start of the experiment, male rats were about 7 weeks old and females 10 weeks, based on their body weights.
- Weight at study initiation: The mean initial weight of males and females were 173 g and 167 g, respectively. The mean deviation in animal weights was less than 20 %.
- Housing: The rats were housed in groups of 5 animals each, under conventional conditions, in Makrolon type III cages on low-dust wood granules
- Nutrition: The animals received fixed-formula standard diet Altromin® 1324 pellets and tap water ad libitum. There were feeding troughs fitted in the cage lids as feed containers. Water was offered in polycarbonate bottles holding approximately 700 mL. The nutritional composition and the contaminant content of the standard diet were routinely spot-checked and analysed. The tap water was of drinking quality. The results of the feed and water analyses have been filed. The data available produced no evidence of any influence on the study objective.
From approximately 16 hours prior to application up to 4 hours thereafter feed was withdrawn, all the other time it was available ad libitum. Tap water was available ad libitum during the entire study period.
- Acclimation period: at least 4 days.
- Other: Females were nulliparous and not pregnant. The condition of the animals' health was checked before the start of experiment. Only healthy animals, without any clinical signs, were included in the study.

ENVIRONMENTAL CONDITIONS
- Temperature: room temperature (22 ± 2°C)
- Humidity: about 50 ± 10 %
- Air changes: approximately ten air changes per hour
- Photoperiod: 12-hour light/dark cycle (artificial light from 6 a.m. to 6 p.m. CET)
- Other: All animals of this study were kept in one animal room. For reasons of capacity, animals from other toxicological studies were temporarily housed in the same animal room. Mixing up of the animals or mutual influence were avoided by appropriate organisation of the operations.

IN-LIFE DATES: From: 1990-09-06 To: 1990-09-20

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1,2-propanediol
Details on oral exposure:
DOSE VOLUME APPLIED:
Application volume of 10 mL/kg bw

Doses:
Rationale for the selection of the dose:
According to OECD Guideline 401 of Feb. 24, 1987, sufficient assessment of acute oral toxicity is achieved as a rule, even if no substance related lethality occurs at a dose of 2000 mg/kg body weight. The following dose was administered: 2000 mg/kg body weight.
No. of animals per sex per dose:
5 male and 5 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration (day 0), after one week and at the end of the 14-day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the 14-day observation period.
Clinical signs:
All males and one female showed rough coat as a sign of intoxication after single administration of 2000 mg/kg. Two males additionally displayed increased salivation and apathy. The signs appeared approximately half an hour after the application, were of slight-to moderate intensity and persisted up to 24 hours after the treatment.
Body weight:
Growth of the animals was not affected.
Gross pathology:
Necropsy findings: The animals sacrificed at the end of study did not show any noticeable gross pathological findings.
The following signs of intoxication were observed: rough coat, increased salivation and apathy.
Other findings:
- Analytical investigations:
The analytical investigations into the stability of the test compound showed that it was stable for the duration of use in the concentration range employed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for male and female rats was greater than 2000 mg/kg bw.
Executive summary:

Acute toxicological investigations with male and female Wistar rats were conducted after oral administration (gavage) of the test substance in accordance with OECD guideline 401. The LD50 for male and female rats was determied to be greater than 2000 mg/kg bw and was not exactly determined. The following signs of intoxication were observed: rough coat, increased salivation and apathy. The body weight development of male and female rats was not affected. No animal died during the 14-day observation period. None of the animals sacrificed at the end of study showed any unusual gross pathological features.