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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
No guideline followed but method is comparable to OECD TG 404 in principle.
Deviations:
yes
Remarks:
No guideline followed but method is comparable to OECD TG 404 in principle.
Principles of method if other than guideline:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
Cas Number:
81-39-0
Molecular formula:
C24H18N2O2
IUPAC Name:
3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Macrolex Rot 5B

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Body weight between 2.3 and 2.8 kg; 6 male and 6 female rabbits.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 ml test item (50% test item 50% water)
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
6 male and 6 female
Details on study design:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Other effects:
no effect on clinical observations, feed intake, body weight development

Any other information on results incl. tables

No irritation was observed on the intact and scarificed skin at any time point.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No adverse effects observed. Not irritating.
Executive summary:

0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize. No irritation was observed on the intact and scarificed skin at any time point.