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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
- Directive CEE
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Strain: Sprague-Dawley (SPF) ; 5 /sex – 1 treated group
- Age/Bodyweight at start: 6-week old; 175 +/-6g (males); 148+/-6g (females)
- Temperature: 21+/-2°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 5 rats/sex/cage, on sawdust
- Food and water ad libitum, except before dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % MC (Methyl cellulose)
Details on oral exposure:
- overnight fasting before dosing
- dose volume: 10ml/kg
Doses:
2000 mg / kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- 2-week observation period after dosing
- monitoring: clinical signs and mortality, bodyweight
- terminal kill on Day 15: macroscopic examination

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
no clinical signs
Body weight:
isolated body weight loss in 1/5 females
Gross pathology:
no macroscopic abnormality
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Lethal dose > 2000mg/kg per os.