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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:
key study
Study period:
4 hour exposure
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Trade name 2076 BENZANIL RUBINE 2BL
Purity: 55-60%
Specific details on test material used for the study:
The substance tested was reported as the trade name Benzanil Rubine 2BL which is Direct Red 83-1. Purity was cited at 55-60% (impurities sodium chloride and water).

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3 New Zealand White rabbits supplied by David Percival Ltd, Moston, Scandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.55 to 2.59 kg and were 12 – 16 weeks old.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water (1 g/ml), was introduced under a 2.5 cm X 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape.
Duration of treatment / exposure:
4 hrs after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hrs later, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize (1997) “Dermal and eye toxicity tests.”
An additional observation was made on Day 7 to assess the reversibility of skin reactions.
Number of animals:
3 rats ( 2 males and 1 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight erythema was noted at one treated skin site 1 hr after patch removal.
Very slight oedema was noted at one treated skin site 1 hr after patch removal.
No other evidence of skin irritation was noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material , 2076 BENZANIL RUBINE 2BL, did not meet the criteria for classification as irritation or corrosive according to EU labelling regulations. No symbol and risk phrase are required.
Executive summary:

The test material did not meet the criteria for classification as irritation or corrosive according to CLP regulation (1272/2008).