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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Remarks:
Acute dermal toxicity protocol
Adequacy of study:
key study
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Remarks:
Acute dermal toxicity protocol
Adequacy of study:
key study
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
other: OECD 402, Acute Dermal Toxicity
Principles of method if other than guideline:
Relevant data are obtained on the endpoint in studies of acute dermal toxicity and skin sensitisation
GLP compliance:
not specified
Remarks:
not specified in publication
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
5000 mg/kg bw. Considering a density of 0.9326 and average weight of a test rabbit of 2 kg, a dose of approximately equivalent to 2.7 ml was applied to the torso of the animals
Duration of treatment / exposure:
Not specified
Observation period:
Not specified
Number of animals:
6
Details on study design:
not specified
Irritation parameter:
other: qualitative assessment
Remarks:
visual examination
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Remarks:
no skin irritation effects noted among the other pathologies described in report
Irritant / corrosive response data:
In an acute dermal toxicity study with 6 rabbits with occlusive exposure for 24 h, 1 animal died and necropsy results were described. No mention was made of skin irritation.
Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal toxicity study in rabbits was informative for the endpoint of skin irritation. Animals exposed to the test substance under an aggressive protocol failed to show notable skin irritation. This data suggests that, like other structural analogues, the test substance is not a skin irritant.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 402, Acute Dermal Toxicity
Principles of method if other than guideline:
Relevant data are obtained on the endpoint in studies of acute dermal toxicity and skin sensitisation
GLP compliance:
not specified
Remarks:
not specified in publication

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
5000 mg/kg bw. Considering a density of 0.9326 and average weight of a test rabbit of 2 kg, a dose of approximately equivalent to 2.7 ml was applied to the torso of the animals
Duration of treatment / exposure:
Not specified
Observation period:
Not specified
Number of animals:
6
Details on study design:
not specified

Results and discussion

In vivo

Results
Irritation parameter:
other: qualitative assessment
Remarks:
visual examination
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Remarks:
no skin irritation effects noted among the other pathologies described in report
Irritant / corrosive response data:
In an acute dermal toxicity study with 6 rabbits with occlusive exposure for 24 h, 1 animal died and necropsy results were described. No mention was made of skin irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal toxicity study in rabbits was informative for the endpoint of skin irritation. Animals exposed to the analogue test substance under an aggressive protocol failed to show notable skin irritation. This data suggests that, like other structural analogues, the target (registered) test substance is not a skin irritant.