Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 2, 1992-Nov. 19, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 143-167 g males, 129-135 g females
- Fasting period before study: 16 hrs
- Housing: up to 5 animals of the same sex in Makrolon Type III cages, identified by skin and tail markings and cage cards
- Diet (e.g. ad libitum): Ssniff R 10, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: Nov. 3, 1992 To: Nov. 19, 1992

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
A volume of 2.33 cm2/kg was applied via intubation to the animals.
Doses:
A preliminary dose of 2,000 mg/kg was given orally to 2 male and 2 female rats. For the limit test, 3 male and 3 female rats were given 2,000 mg/kg.
No. of animals per sex per dose:
Five of each sex were tested.
Details on study design:
The animals were examined for clinical symptoms 0.5, 1, 2, 3, 4, 5, and 6 hours after application, as well as once a day for two weeks. Body weight of the animals was determined on day 0, day 7, and day 14. After 14 days, the animals were sacrificed with carbon dioxide and examined macroscopically for recognizable organ defects.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed during the study.
Clinical signs:
No adverse symptoms were observed after 14 days of observation.
Body weight:
Body weights were normal.
Gross pathology:

There were no macroscopic abnormalities in the organs.

Applicant's summary and conclusion

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

This study examined the acute oral toxicity of the test substance to rats. A group of 5 male and 5 female rats were given a dose of 2000 mg/kg bw test substance. The rats were then monitored over the next 14 days for clinical signs and mortality. Body weights were taken on days 0, 7, and 14 of the study. At the termination of the study, all animals were sacrificed, and examined for macroscopic abnormalities. No animals died during the study. No adverse effects to body weight or clinical signs were noted. The acute oral LD50 for male and female rats was > 2000 mg/kg bw. The test substance is not classified as toxic under EU GHS guidelines.