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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:
weight of evidence
Study period:
1984-03-27 to 1984-03-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD guideline, GLP, observation period only 72 h.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period only 72 h
Principles of method if other than guideline:
The study was based on that described in the Journal Officiel de la Republique Francaise, 21 February 1982. Six male New Zealand White rabbits were treated with the undiluted test substance for 24 h under semiocclusive conditions to examine the skin irritating potential of the test substance.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics & Rosemead Rabbits Ltd., Lea Valley, Essex
- Age at study initiation: approximately 12 - 16 weeks
- Weight at study initiation: 2.78 - 3.10 kg
- Housing: individually
- Diet: free access to a standard laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire)
- Water: free access to tapwater
- Acclimation period: a minimum period of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Humidity (%): Humidity was not controlled but remained within a range of 52 - 58% RH recorded daily on a wet and dry bulb hygrometer.
- Air changes (per hr): approximately 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Type of wrap if used: The test material was introduced under a composite patch which consisted of a 2.5 cm x 2.5 cm square of absorbant lint BPC backed by a 4.0 cm x 4.0 cm square of absorbant lint BPC with a final backing of a 3.0 cm x 3.0 cm square of polythene. The patches were applied to the abraded and intact test sites of each animal and held securely in position by two lengths of Sleek adhesive strapping (Smith & Nephew Limited) in the form of a cross. An elasticated corset was then applied (Seton's Tubigrip) to prevent interference with the patches.

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gentle swabbing with cotton wool soaked in lukewarm water or other suitable solvent.
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize J.H (1959): Association of Food & Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemieals in Foods, Drugs and Cosmetics"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #4
Time point:
other: 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #3, #6
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #2
Time point:
other: 24/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
erythema score
Basis:
animal: #5
Time point:
other: 24/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Remarks:
24 hours exposure
Irritation parameter:
edema score
Basis:
animal: #1, #3, #6
Time point:
other: 24/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #2, #4
Time point:
other: 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
The test material produced slight or well-defined cutaneous irritation in 6/6 rabbits. Very slight to moderate erythema, with or without very slight oedema was observed at the intact and abraded sites of all six rabbits at the 24 hours reading. The reactions had ameliorated completely in one rabbit by the 72 hours observation when very slight to well-defined erythema, with or without very slight oedema persisted at the intact and abraded sites of four rabbits and the abraded site only of the remaining rabbit.
No data is available on reversibility after 72 h. As most of the 72 h scores were lower compared to the 24 h scores, a full reversibility is expected after at least 21 days.
Other effects:
no

Any other information on results incl. tables

Exposition:  24 h
Animal  Reading  Erythema Edema
1 24 h 1 0
2 24 h 2 1
3 24 h 1 0
4 24 h 1 1
5 24 h 2 1
6 24 h 1 0
1 72 h 0 0
2 72 h 1 0
3 72 h 1 0
4 72 h 0 0
5 72 h 2 1
6 72 h 1 0
1 24 - 72 h 0.5 0
2 24 - 72 h 1.5 0.5
3 24 - 72 h 1 0
4 24 - 72 h 0.5 0.5
5 24 - 72 h 2 1
6 24 - 72 h 1 0
mean (animal 1-6) 24 - 72 h 1.1 0.3

The test material produced a Primary Cutaneous Irritation Index of 1.5 and was classified as a slight irritant to the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this primary dermal irritation study in rabbit, Allyl methacrylate was slightly irritating.
Executive summary:

In a primary dermal irritation study similar to OECD 404 6 rabbits were dermally exposed to 0.5 mL of undiluted Allyl methacrylate to approximately 2.5 cm² skin area. Two application sites per animal were treated, one site was left intact, the other was abraded. Test sites were covered with an semi-occlusive dressing for 24 hours. Animals were observed for 72 hours. Irritation was scored according to Draize J.H (1959): Association of Food & Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics". In this study, Allyl methacrylate was slightly irritating and is not a dermal irritant.. Study performance does not comply with requirements of the relevant recent EU and OECD guidelines, where a less vigorous application regime with an exposure period of 4 hours, treatment of only intact skin is stipulated.

Thus, it can be assumed, that a substance which shows no irritating activity under the application regime of Association of Food & Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" will also be non irritating under the application regimes of the relevant recent EU and OECD guidelines. Therefore the study is adequate for C&L purposes.