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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
other: well performed GLP compliant OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

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:
1,4-bis(mesitylamino)anthraquinone
EC Number:
204-155-7
EC Name:
1,4-bis(mesitylamino)anthraquinone
Cas Number:
116-75-6
Molecular formula:
C32H30N2O2
IUPAC Name:
1,4-bis(mesitylamino)anthraquinone

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K.
- Age at study initiation: 12 - 17 weeks
- Weight at study initiation: 2.23 - 2.34 kg
- Housing: individually housed in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers, Limited, New Leake, Boston, Lincolnshire, U.K.) ( ad libitum)
- Water: drinking water (ad libitum)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 60 - 65
- Air changes (per hr): PPROX: !%
- Photoperiod: 12 hrs dark /12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
the test material was moistened with distilled water
Controls:
no
Amount / concentration applied:
A quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (2 females, 1 male)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (gauze patch)
- Type of wrap if used: surgical adhesive tape (2.5 cm x 4 cm) additionally fixed with an elastic corset

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in diethyl ether.
- 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 to 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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial signs of slight irritation were fully reversible within 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: no signs of irritation at any time
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites one hour after patch removal, at two treated skin sites at the 24-hour observation and at one treated skin site at the 48-hour observation.

Very slight oedema was noted at two treated skin sites at the 24-hour observation. No other adverse skin reactions were noted.

All treated skin sites appeared normal 72 hours after treatment.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test result, it is concluded thatthe test substance is not irritating to skin.
Executive summary:

A 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 Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B.4. in Commission Directive 84/449/EEC.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. All treated skin sites appeared normal 72 hours after treatment. No corrosive effects were noted.

Based on these findings it is concluded that the test item is not irritating to skin.