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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal and authoritative database

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
WHO Food Additives
Author:
Joint FAO/WHO Expert Committee on Food Additives
Year:
1980
Bibliographic source:
Joint FAO/WHO Expert Committee on Food Additives, 2004
Reference Type:
other: Authoritative data base
Title:
HSDB (Hazardous Substances Data Bank)
Author:
U.S National Library of Medicine
Year:
2011
Bibliographic source:
HSDB (Hazardous Substances Data Bank), U.S National Library of Medicine ; 2011
Reference Type:
secondary source
Title:
REPORTS of the Scientific Committee on Cosmetology (seventh series)
Author:
Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series),1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin irritation potential of test chemical on 200 human subjects
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
(ALLURA RED AC)
- Substance type: Organic
- Physical state: solid

Test animals

Species:
other: Human
Strain:
not specified
Details on test animals and environmental conditions:
No data available

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
neat or as a 25% aqueous solution to the skin
Duration of treatment / exposure:
72 hours, and this was followed by a 24-hour application 10 to 14 days later
Observation period:
10 to 14 days later
Number of animals:
200 human subjects
Details on study design:
no data availble

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None of the subjects exhibited compound induced irritation.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
None of the subjects exhibited compound induced irritation . Hence,the test chemical was considered to be not irritating to human skin.
Executive summary:

A prophetic patch test was conducted on 200 human volunteers to assess the dermal irritation potential of the test chemical.

The test chemical was applied on the human skin in the concentration 25% neat or in aqueous solution for 72 hours followed by one 48 hours application 10-14 days later. None of the subjects exhibited compound induced irritation . Hence, the test chemical was considered to be not irritating to human skin.