Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Apr - 10 Jun 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
adopted in 1992
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:
Wistar
Remarks:
Hoe: WISKf(SPF71)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Age at study initiation: males ~7 weeks, females ~8 weeks
- Weight at study initiation: males: 170-179 g, females 163-170 g
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: commercial diet ( ssniff R/M-H (V 1534)), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one day (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 Apr 1996 - 01 May 1996

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE: The animals received the compound as a 20 % solution in deionized water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test substance was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.
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: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once.
- Frequency of weighing: once a week
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No lethality occurred during the study.
Clinical signs:
All animals showed squatting posture and irregular respiration at 30 min up to 4 hours after administration.
All animals showed swollen abdomen one and two days after administration.
All clinical signs were resolved within day 4 (3rd day after administration).
Body weight:
Development of body weight was not affected.
Gross pathology:
No macroscopically visible changes were seen during necropsy performed at the end of observation period.

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.