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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:
1990-09-27 to 1991-01-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylanthraquinone
EC Number:
201-535-4
EC Name:
2-ethylanthraquinone
Cas Number:
84-51-5
Molecular formula:
C16H12O2
IUPAC Name:
2-ethyl-9,10-anthraquinone
Details on test material:
- Name of test material (as cited in study report): 2-Ehtylanthraquinone
- Physical state: pale yellow flakes
- Analytical purity: > 95%
- Impurities (identity and concentrations): not reported
- Purity test date: not reported
- Lot/batch No.: 146 - 332
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approximately 12 to 16 weeks
- Weight at study initiation: 2.26 - 2.54 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.)
- Water (e.g. ad libitum): ad libitum (mains drinking water)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22. On one occasion, the temperature was outside the upper limit specified in the protocol (21°C).
- Humidity (%): 49-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27.9.1990 To: 30.9.1990

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped free from fur
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
2 females, 2 males
Details on study design:
TEST SITE
- Area of exposure: dorsal/ flank area
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate t o severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well- defined by definite raising ): 2
Moderate oedema (raised approximately 1 millimetre ): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4

Primary Irritation Index
The scores for erythema and oedema a t the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided
by 6 to give the primary irritation index of the test material. The test material was classified according to the following scheme:
Primary irritation index = 0 : Non-irritant
Primary irritation index > 0 - 2: Mild irritant
Primary irritation index > 2 - 5: Moderate irritant
Primary irritation index > 5 - 8: Severe irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean of scores at 24 and 72 hours
Score:
0.3
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
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:
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:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Erythema/Eschar Formation

Reading (hours)

Individual Scores – Rabbit Number and Sex

(bodyweight kg)

86 female

(2.26)

89 male

(2.54)

92 female

(2.37)

1

1

0

1

24

1

0

1

48

0

0

0

72

0

0

0

Total of 24, 48 and 72 hours

1

0

1

Mean Score of 24, 48 and 72 hours

0.3

0.0

0.3

 

Oedema Formation

Reading (hours)

Individual Scores – Rabbit Number and Sex

(bodyweight kg)

86 female

(2.26)

89 male

(2.54)

92 female

(2.37)

1

1

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Total of 24, 48 and 72 hours

0

0

0

Mean Score of 24, 48 and 72 hours

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as a mild irritant to rabbit skin. No corrosive effects were noted. The test material can be classified as non-irritant according to Regulation (EC) No 1272/2008 (CLP).
Executive summary:

A GLP-study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD TG No. 404.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced incidents of very slight erythema and an isolated incident of very slight oedema. The test material produced a primary irritation index of 0.3 (out of 8) and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.

The test material can be classified as non-irritant according to Regulation (EC) No 1272/2008 (CLP).

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