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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:
May 26, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Principles of method if other than guideline:
Test method similar to OECD 404.
GLP compliance:
no
Remarks:
pre GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
267-224-0
EC Name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
67827-60-5
Molecular formula:
C31H26N3O6S.Na
IUPAC Name:
sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.6 to 2.0 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG Gossau SG- ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 852, 854, 855
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no dermal effect observed
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: 856
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intanct skin
Irritation parameter:
erythema score
Basis:
animal: 857, 859
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 852, 854, 855
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no dermal effect observed
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 856
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 857, 859
Time point:
other: mean score following grading at 24, 48, 72 hours
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

Method:

The skin irritation was determined in an irritation test on rabbits according to Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 404.

Result:

Not irritant.