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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
June 1st, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959, of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone
EC Number:
943-670-8
Molecular formula:
not applicable
IUPAC Name:
Reaction mass of 1,5-diamino-4,8-dihydroxy(4-hydroxyphenyl)anthraquinone and 1,5-diamino-4,8-dihydroxy-2-(4-methoxyphenyl)anthraquinone
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: 1.5 to 2 kg- Housing: individual housing in metal cages- Diet: NAFAG, Gossau SG, standard rabbit food, ad libitum- Water: ad libitum- Acclimation period: 4 days minimumENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1- Humidity (%): 55 ± 5- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and non-abraded skin
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
0 h, 48 h after patch removal
Number of animals:
6 animals: 3 male and 3 female
Details on study design:
TEST SITE- Area of exposure: 2.5 cm × 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: #1 and #6
Time point:
other: 24, 48 and 72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
other: no dermal effects observed
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: #2, #3, #4, #5
Time point:
other: mean 24, 48 and 72h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 24, 48 and 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no dermal effects observed
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no dermal effects observed
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal: #1, #3, #5
Time point:
other: mean 24, 48 and 72h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal: #2, #6
Time point:
other: mean 24, 48 and 72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: abraded skin

Any other information on results incl. tables

Results

Intact skin

Animal/sex Reaction 0 h 24 h 48 h 72 h Mean 24, 48 and 72 h
1 M Erythema 0 0 0 0 0
2 M Erythema 0 0 0 0 0
3 M Erythema 0 0 0 0 0
4 F Erythema 0 0 0 0 0
5 F Erythema 0 0 0 0 0
6 F Erythema 0 0 0 0 0
1 M Oedema 1 1 0 0 0,33
2 M Oedema 0 0 0 0 0
3 M Oedema 0 0 0 0 0
4 F Oedema 0 0 0 0 0
5 F Oedema 0 0 0 0 0
6 F Oedema 1 1 0 0 0,33

Scarified skin

Animal/sex Reaction 0 h 24 h 48 h 72 h Mean 24, 48 and 72 h
1 M Erythema 0 0 0 0 0
2 M Erythema 0 0 0 0 0
3 M Erythema 0 0 0 0 0
4 F Erythema 0 0 0 0 0
5 F Erythema 0 0 0 0 0
6 F Erythema 0 0 0 0 0
1 M Oedema 2 2 0 0 0.67
2 M Oedema 1 1 0 0 0.33
3 M Oedema 2 2 0 0 0.67
4 F Oedema 3 3 0 0 1
5 F Oedema 2 2 0 0 0.67
6 F Oedema 1 1 0 0 0.33

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Non-skin irritant
Executive summary:

The substance was tested for skin irritation potential using the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959, the US Association of Food and Drug Officials (AFDO).

2.5 cm × 2.5 cm intact and abraded skin of 3 male and 3 female Himalayan rabbits were exposed to 0.5 ml of test substance in an occlusive preparation for 24 h. Skin reactions were recorded at 0 h and 48 h after patch removal. For the purpose of calculating erythema and edema scores at 24, 48 and 72 h after patch removal, the following method was adopted: scores at 0 h were taken as scores at 24 h and scores at 48 h were also taken as scores at 72 h.

Intact skin showed no skin reactions at all for erythema; 2/6 rabbits show very slight edema at 0h, but this skin reactions were reversible within 48h.

No erythema was observed also in scarified skin. Slight edema was observed in scarified skin at 0 h. These skin reactions were reversible within 48 h.

For all animals, the calculation of mean skin reaction scores (24, 48 and 72 h) after patch removal gave the following values for intact skin: erythema score = 0 and oedema score = 0.1; and for abraded skin: erythema score = 0 and oedema score < 1.

Therefore, the test substance is a non-skin irritant.