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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 2004/73/EG, B.1bis (Fest-Dosis-Methode); OECD 420 (2001)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
Preliminary sighting study, 300 mg/kg bw: 2 (female)
Main study, 2000 mg/kg bw: 4 (female)
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No signs of systemic toxicity.
Body weight:
All animals showed the expected gains in body weight over the study period
Gross pathology:
No abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral medium lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System Category – Unclassified).