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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 404 in compliance to GLP.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2011
Report date:
2011

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:
Multi constituent substance
EC Number:
916-603-5
IUPAC Name:
Multi constituent substance
Details on test material:
Test substance : Basic Red 76 (COLIPA number C008)
Batch number : 0050644101
Methylsulphate anion : 11.8%
Chloride ion : 1.6%
Water : 5.1%
o-Anisidine : 5ppm
Purity : 98.1% (HPLC)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: test item moistened with water
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
Four hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
Three
Details on study design:
The dorsal fur was clipped approximately 24 hours prior to treatment to expose an area of ~150cm2. The intact clipped back skin of each animal was exposed to 500mg of the test item moistened with water. The test item was placed on a surgical gauze patch (~16cm2). The patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The patch was removed after 4 hours of semi-occlusive contact and the skin was flushed with lukewarm tap water to clean the application site. The animals were examined for signs of erythema, eschar and oedema formation approximately 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item. The skin reaction was assessed according to the numerical scoring system listed in the EEC Directive 92/69/EEC.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours, 7,10, 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours, 7,10, 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours, 7,10, 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours, 7,10, 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours, 7,10, 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours, 7,10, 14 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No visible signs of irritation were observed. Slight red staining was observed in all animals from 1 hour after exposure up to 72 hours after treatment. Staining persisted in one animal up to a 14-day examination. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for edema grades separately. The mean erythema/eschar score and the mean edema score was 0.0 for all three animals. No erythema and no swelling (edema) was noted in any animal at any time. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to rabbit skin.
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD guideline 404. The test item was applied by topical semi-occlusive application of 0.5g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of the treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for edema grades separately. The mean erythema/eschar score and the mean edema score was 0.0 for all three animals. The application of the test item to the skin resulted in no signs of irritation. Slight red staining was observed in all animals from the 1 hour reading up to 72 hours after treatment and persisted in one animal up to the 14 -day examination, the end of the observation period for all animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. The test item did not induce significant or irreversible damage to the skin. Based upon the referred classification criteria the test item is considered to be not irritating to rabbit skin.