Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3 - 9 Mar 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. The observation period was 6 days, few details were reported, the administration volume was unusually high, the analytical purity was not stated.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
yes
Remarks:
observation period 6 days, few details reported, the administration volume was unusually high, analytical purity not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1

Test animals

Species:
mouse
Strain:
other: NMRI EOPS
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation:20 - 21 g (range)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: observations of mortality and signs of toxicity were made 3 h after administration and daily thereafter; animals were weighed prior to dosing and prior to necropsy.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period.
Clinical signs:
other: From 30 minutes until 1 hour after administration an unspecified number of the mice had closed eyes, were lethargic and had irregular breathing. No clinical signs of toxicity were observed during the rest of the 6-day observation period.
Gross pathology:
No substance-related findings were noted during the necropsy.

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
Conclusions:
CLP: not classified