Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation / corrosion, other
Remarks:
in vivo study
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
refer to confidential details on test material
IUPAC Name:
refer to confidential details on test material

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: bi-distilled water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Irritant / corrosive response data:
the treated skin was red coloured, and it did not allow the evaluation of the erythema at 24h, while for the other readings was possible

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.
Executive summary:

The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.