Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.02.1999-11.03.1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
other: US Environmental Protection Agency (EPA) Health Effects Test Guidelines OPPTS 870.1100, 1998
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
3 male + 3 female. 8-12 weeks at the beginning of the study.
The animals were housed in groups of three by sex in solid-floor polypropylene cages gurnished with woodflakes.
With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food.
The animal room was maintained at a temperature of 19-21ºC and relative humidity of 46 to 59%. The rate of air excange was approximately fifteen changes per hour and the lighting was controlled by a time swich to give twelve hours continuous light and twlve hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 m/kg
Dose level: 2000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The toxicity information available suggested that mortality was unlikely at the maximum dose level.
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
Signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, ataxia, decreased respiratory rate and laboured respiration, developing on the day of dosing and lasting up to five days after dosing.
Body weight:
At the start of the study the males weighed 235 to 245g, and the females 201 to 205g.
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnomalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The substance has a acute oral LD50 > 2000 mg/kg. No deaths were found.