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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
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:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Test conducted following Code of Federal Regulations, Title 16, section 1500.41
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Acid Orange 116
IUPAC Name:
Acid Orange 116
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
- Weight at study initiation: 3.2 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 - 14 d

ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 18 °C
- Humidity: 40 %
- Photoperiod hrs dark / hrs light: 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
- Concentration: diluted 1:1 in water
Duration of treatment / exposure:
24 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: elastic permanent

PREPARATION OF TEST SITE
The flank skin of 6 rabbits was depilated on an area of ​​about 8 × 8 cm on both sides of the trunk with an electric hair clipper 24 hours before the start of the test. The right flank skin was also skarified by means of a cupping cupper.

OBSERVATION TIME POINTS
24 h (at removal of bandage, 48 h, 72 h and 8 days after start of the test

SCORING SYSTEM:
Erythema
0 no erythema
1 very slight, almost imperceptible erythema
2 well-developed erythema
3 moderate to severe erythema
4 severe erythema (dark red) to mild scabbing (deep skin injury) - burns

Oedema
0 no oedema
1 very slight, almost imperceptible oedema
2 mild edema (limits well marked by clear lifting)
3 moderate oedema (approximately 1 mm lift)
4 severe oedema (lifting more than 1 mm and exceeding the limits of the application)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Remarks:
due to staining of skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: score at 48 h, assumed as equal to highest score at 24 or 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other:
Remarks:
score at 48 h, assumed as equal to highest score at 24 or 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: score at 48 h, assumed as equal to highest score at 24 or 72 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: score at 48 h, assumed as equal to highest score at 24 or 72 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: score at 48 h, assumed as equal to highest score at 24 or 72 h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: score at 48 h, assumed as equal to highest score at 24 or 72 h

Any other information on results incl. tables

time skin irritation / animal no.
1 2 3 4 5 6
erythema intact 24 h * * * * * *
72 h * * * * * *
8 d * * * * * *
scarified 24 h * * * * * *
72 h * * * * * *
8 d * * * * * *
oedema intact 24 h 2 1 3 3 3 3
72 h 1 0 2 1 1 2
8 d 0 1 2 2 0 0
scarified 24 h 3 2 4 3 4 4
72 h 3 1 3 2 3 3
8 d 3 1 3 2 2 3

* Reading not possible due to substance-related staining of skin

Applicant's summary and conclusion

Interpretation of results:
other: skin irritant according to the CLP regulation (EC 1272/2008)
Conclusions:
Irritant to the rabbit skin.
Executive summary:

Method

Skin irritation assessement based on Code of Federal Regulations, Title 16, section 1500.41. Test substance was applied on clipped skin of 6 rabbits, both intact and scarified, under occlusive coverage for 24 h. Observations were done after 24 h , 48 h (not reported), 72 h and up to 8 d after starting of experiment.

Results

Presence of erythema could not be ascertained due to staining. Oedema was noted in all rabbits; more pronounced effects were reported on scarified skin with respect to intact skin. In all but one cases, effects decreased upon 8 days.

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