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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:
Nov/Dec 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1980
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
274-675-7
EC Name:
Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
70571-81-2
Molecular formula:
C22H17N3O6S.Na
IUPAC Name:
sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd, Huntingdon, UK
- Age at study initiation: no data
- Weight at study initiation: 2.8 to 3.1 kg
- Housing: single
- Diet (e.g. ad libitum): ssniff K ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours; 7 and 14 days
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: full
- Type of wrap if used: covered with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Due to the staining of the test material detection of reddening was temporarily difficult; at 1 h no erythema value was derived in all animals, at 24 h in one animal. However, as the other two animals did not show any reddening, this was assumed to also be true for the third animal
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation
Other effects:
reversible staining of the skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.
Executive summary:

A sample of the test item was tested in three female New Zealand White rabbits for acute dermal irritating properties according to OECD guideline 404. The dermal exposure period was 4 hours under semi-occlusive conditions. The test item did not cause any skin effects. Thus, under the conditions of this study, the test item can be considered as non-irritating.