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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:
20.06.1989-28.06.1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 404, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 21 May 1981. EEC Directive 84/449/EEC, Part B: methods for the determination of Toxicity, B5. Acute Toxicity. Skin irritation. Official Journal of the European Communities, No L251, pp. 106-108
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were housed individually. Conventional laboratory diet (mümmel z, ssniff / Soest) and an unrestricted supply of drinking water
were available. The temperature of the experimental animal room was 18 °C (±2 °C) and the relative humidity 40 to 50 %.
Lighting sequence: 12 hrs light, 12 hrs darkness
Condition time: 7 days

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g, undiluted
Duration of treatment / exposure:
4 hours
At the end of the exposure period, residual test substance was removed by water.
Observation period:
After patch removal the skin was examined at 1 h, then at 24, 48 and 72 hrs and at day 8.
Number of animals:
3, 10 weeks old
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data availible
- Type of wrap if used: non-irritating tape, semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by water

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.
Remarks:
mean 24 + 48 + 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.
Remarks:
mean 24 + 48 + 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.
Remarks:
mean 24 + 48 + 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.
Remarks:
mean 24 + 48 + 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.
Remarks:
mean 24 + 48 + 72 h
Other effects:
No evidence of systemic effects.

Any other information on results incl. tables

Erythema Edema
24h 48h 72h 9d 24h 48h 72h 8d
Animal 1 1 1 0 0 2 1 1 0
Animal 2 0 0 0 0 2 2 1 1
Animal 3 1 1 0 0 1 1 1 0
Mean 0.66666667 0.66666667 0 0 1.66666667 1.33333333 1 0.33333333
Total-mean 0.44444444 1.33333333
Erythema Edema

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not irritating: Criteria used for interpretation of results: OECD GHS
Conclusions:
Isotridecyl methacrylate has some mild irritating potential to skin.
However, it is non-irritating with respect to EU and UN-GHS classification criteria.
Executive summary:

In a primary dermal irritation study (OECD 404, GLP) 3 New Zealand White rabbits were dermally exposed for 4 hours with 0.5 g undiluted Isotridecyl methacrylate under semiocclusiv conditions. Animals were observed after 1h, 24h, 48h 72h and after 8 or 9 days. The test was reevaluated acc. CLP criteria. Mean erythema scores after 24, 48 and 72 hours were 0, 0.33 and 0.66 of max. 4. Mean edema scores 0, 1.33 and 1.66 of max. 4. All reactions were fully reversible after 72 h or 8 days. Under CLP criteria Isotridecyl methacrylate is not irritating to skin.

The results demonstrate that Isotridecyl methacrylate (CAS 85736-97-6) is not a dermal irritant.

Therefore the test substance has to be classified - according to EU and GHS classification criteria - as non irritant for skin (GHS-hazard category: none).

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