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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not declared
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study was provided us by ECHA under the 12 years rule. Available data contain scanty study details: the limited amount of information and the lack of the full study report do not allow a proper reliability assessment.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)
IUPAC Name:
EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)

Test animals

Species:
rat
Strain:
other: Sprague-Dawley, ICO:OFA-SD (J0PS Caw)
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals, males, 2000 mg/kg
5 animals, females, 2000 mg/kg
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths were observed.

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Not declared.
Gross pathology:
In animals killed at the end of the study, no macroscopic changes were observed.
Other findings:
No skin reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for dermal acute toxicity.