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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
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 (incl. QA statement)

Test material

Constituent 1
Test material form:
liquid: viscous
Details on test material:
- Substance type: Technical product.
- Storage condition of test material: No data.

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: 12-16 weeks.
- Weight at study initiation: 2.21-2.93 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum period of five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19-22°C.
- Humidity: 60-65%.
- Air changes: approximately 15 air-changes per hour.
- Photoperiod: 12 hours dark / 12 hours light.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml.
Duration of treatment / exposure:
Four hours.
Observation period:
72 hours.
Number of animals:
Three rabbits.
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm.
- Type of wrap if used: gauze patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours, the test sites were examined for evidence of primary irritation and scored according to the Draize scale (0 = no reaction ; 4 = severe reaction)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Individual mean scores: #1 0.3, #2 0.7, #3 0.3.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was noted at two treated skin sites one hour after patch removal, at all treated skin sites at the 24-hour observation and at one
treated skin site at the 48-hour observation. All treated skin sites appeared normal 72 hours after treatment (see Table 1).

Any other information on results incl. tables

Table 1: Mean scores for dermal irritation

Skin reaction

Reading (hours)

Individual scores

Female (2.93 kg)

Male (2.65 kg)

Male (2.21 kg)

Erythema/Eschar Formation

1

0

1

1

24

1

1

1

48

0

1

0

72

0

0

0

Oedema Formation

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to Regulation 1272/2008/EC.
Conclusions:
Based on the results of a GLP-compliant guideline study, the substance is considered to be not irritating to rabbit skin.
Executive summary:

Skin irritating/corrosive effects of 2-amylanthraquinone were studied in 3 albino rabbits. 0.5 ml of 2-amylanthraquinone was applied on the shaved skin of test animals under semi-occlusive coverage. After 72 hours of observation no signs of skin irritation or corrosion were present. The test substance is considered to be non irritating to the skin of albino rabbit under the conditions of this study.