Registration Dossier

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HsdCpb: WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 164-191 g
- Fasting period before study: 17 hours
- Housing: Kept in Makrolon Type III cages separately with a shetler placed on mobile racks. They were kept on metal grids 24 hours prior to administration on the first day of the experiment, and then on conventional softwood granulate as bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 56-75%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: To: June 5, 1997 to June 25, 1997

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
The rats received 20 ml/kg test material via intubation.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
All rats were monitored for at least 6 hours after administration and checked daily thereafter. All rats were weight before treatment and on days 2, 4, 6, 8, 11, 13 and 15 of the experiment. After 14 days, the animals were sacrificed with carbon dioxide and were subjected to gross pathological investigations.

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:
The body weight development of the treated rats was 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 15 days for clinical signs and mortality. Body weights were taken on days 0, 2, 4, 6, 8, 11, 13 and 15 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.