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Diss Factsheets

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:
June 2nd to 9th, 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
not specified
Remarks:
Test performed according to the Proposed Guideline, Federal register, Vol. 43, n. 163, August 22nd, 1978
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disperse Red 060
IUPAC Name:
Disperse Red 060
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: individual housing in metal cages
- Diet: NAFAG, no. 814, Gossau SG, standard rabbit food, ad libitum
- Water: ad libitum
- Acclimation period: 4 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: propylene glycol + saline (70:30 parts)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 %
Duration of treatment / exposure:
24 h
Observation period:
24 h, 48 h, 72 h, 4 d and 7 d 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:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Assessment

Due to intensive staining by the test substance, erythema was not assessable. For the purpose of calculating the primary irritation index, erythema was assumed to be equal to edema based on existing correlation (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Skin reaction scores of rabbits

Abraded skin

Animal/sex Reaction 24 h 48 h 72 h 4 d 7 d Mean 24, 48 and 72 h
19 M Erythema 0 0 0 0 0 0
20 M Erythema 1 0 0 0 0 0.33
21 M Erythema 0 0 0 0 0 0
22 F Erythema 1 0 0 0 0 0.33
23 F Erythema 1 0 0 0 0 0.33
24 F Erythema 0 0 0 0 0 0
19 M Oedema 0 0 0 0 0 0
20 M Oedema 1 0 0 0 0 0.33
21 M Oedema 0 0 0 0 0 0
22 F Oedema 1 0 0 0 0 0.33
23 F Oedema 1 0 0 0 0 0.33
24 F Oedema 0 0 0 0 0 0

Intact skin

Animal/sex Reaction 24 h 48 h 72 h 4 d 7 d Mean 24, 48 and 72 h
19 M Erythema 0 0 0 0 0 0
20 M Erythema 0 0 0 0 0 0
21 M Erythema 0 0 0 0 0 0
22 F Erythema 0 0 0 0 0 0
23 F Erythema 0 0 0 0 0 0
24 F Erythema 0 0 0 0 0 0
19 M Oedema 0 0 0 0 0 0
20 M Oedema 0 0 0 0 0 0
21 M Oedema 0 0 0 0 0 0
22 F Oedema 0 0 0 0 0 0
23 F Oedema 0 0 0 0 0 0
24 F Oedema 0 0 0 0 0 0

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 based on the Proposed guidelines of the US EPA 163.81 -5 "Primary dermal irritation study," Federal register, Vol. 43, No. 163, August 22, 1978 (1980). 0.5 g of test substance was applied to 2.5 cm × 2.5 cm intact and abraded skin in an occlusive preparation to 3 male and 3 female New Zealand White rabbits. 50 % solution of propylene glycol + saline (70:30 parts) was the vehicle used. The exposure duration was 24 h. Animal skin reactions were scored at 24 h, 48 h, 72 h, 4 d and 7 d after patch removal.

One male and two female rabbits showed slight edema and slight erythema on abraded skin at 24 h only. These skin reactions were reversible within 48 h. No skin reactions were observed on intact skin.

Abraded skin of all six animals had the following mean reaction scores (24, 48 and 72 h): erythema score < 1 and oedema score < 1.

Intact skin of all six animals had the following mean reaction scores (24, 48 and 72 h): erythema score = 0 and oedema score = 0.

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