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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2/3/1993
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch Number C2413/173/3

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
GR101030X was classified as having low aute oral toxicity and the median lethal dose was estimated as being in excess of 2000mg/kg bw is the Wistar rat.
Executive summary:

A study was performed to assess the acute oral toxicity of GR101030X in the Wistar rat. In phase 1, groups of three fasted females were given a single oral dose at pre-determined levels of 200 and 2000mg/kg bodyweight. Phase 2 was performed at 2000mg/kg bodyweight using groups of five female and five male animals. Following dosing the animals were observed for 14 days and at the end of this period were killed and subject to gross necropsy. In phase 2 there were no deaths or clinical signs of toxicity. All animals showed expected bodyweight gain.and no abnormalities were noted at necropsy. GR101030X was therefore classified as of low toxicity and the acute oral median lethal dose was estimated to be greater than 2000mg/kg bodyweight.