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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
up-and-down procedure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 234 - 264 g (males); 191 - 216 (females)
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/5
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, at the end of the observation period.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived treatment with test article.
Clinical signs:
other: Soft stool was the only clinical observation post dosing observed in three animals on day 1.
Gross pathology:
There were no signs of macroscopic postmortem abnormalities at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for the test substance was >2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to guideline
Guideline:
other: EEC test guideline B.9 Number L383A.
Deviations:
yes
Remarks:
except sites were not occluded and residual test material not wiped off
GLP compliance:
yes
Test type:
other: 28-Day Dermal Toxicity in Rats
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Duration of exposure:
5 days/week for 4-weeks
Doses:
0.0, 125.0, 500.0 or 2000.0 mg/kg/day
No. of animals per sex per dose:
Six groups of 10 males and 10 females
Control animals:
yes, concurrent no treatment
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
other: Animals treated with test article exhibited no signs indicative of systemic toxicity. The test material was not visibly irritating to the skin at the exposure site.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 for the test substance is >2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

Justification for classification or non-classification