Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The information is provided from a reliable secondary source.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 41
Deviations:
no
GLP compliance:
no
Remarks:
- the original study was conducted in 1975

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Appearance: Blue powder
- Name of test material (as cited in study report): Sanolin Blue EHRL
- Other name(s): C.I. Acid Blue 182
- Marketing names: Sanolin Blue E-HRL, Sandolan Blue E-HRL 180, Sandolan Blue E-HRL, Alizarinlichtblau HRL
- Degree of purity: High

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
other: distilled water
Controls:
not specified
Amount / concentration applied:
No data
Duration of treatment / exposure:
No data
Observation period:
72 hours
Number of animals:
No data
Details on study design:
The skin irritation was measured using a patch test technique of the test material on the abraded and intact skin of the albino rabbit.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: throughout the 72 hour period
Score:
0
Remarks on result:
other: Assumed score based on description of observations
Irritant / corrosive response data:
Evaluation of skin reactions (scores) was not provided. The summary report states that no animals showed any observable response to treatment throughout the 72 hour observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the conditions of this study, the test material is non-irritating to skin.
Executive summary:

The skin irritation potential of the test material was investigated in accordance with the standard methods prescribed by the Consumer Product Safety Commission of the USA in The Code of Federal Regulations, Title 16, Section 1500, 41.

The test material in distilled water was applied to the intact and abraded skin of Albino rabbits and the skin irritation assessed using a patch test technique that was carried out in an occlusive fashion. Animals were observed for 72 hours.

Evaluation of skin reactions (scores) was not provided. The summary report states that no animals showed any observable response to treatment throughout the 72 hour observation period.

Under the conditions of this study, the test material is non-irritating to skin.