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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Principles of method if other than guideline:
Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials".
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, 2-methyl-, C12-18-alkyl esters
EC Number:
292-095-2
EC Name:
2-Propenoic acid, 2-methyl-, C12-18-alkyl esters
Cas Number:
90551-77-2
IUPAC Name:
90551-77-2
Test material form:
other: liquid
Details on test material:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: rabbit standard diet (Höing 222), ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
Amount / concentration applied:
undiluted 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
24h and 72h post application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data availible
- Type of wrap if used: gummed bandage to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage.

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:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.33
Max. score:
8
Reversibility:
no data
Remarks on result:
other: No data in respect to reversibility for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: No data in respect to reversibility for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.334
Max. score:
4
Reversibility:
no data
Remarks on result:
other: No data in respect to reversibility for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information no classification Criteria used for interpretation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)
Conclusions:
Methacrylic acid ester 14.2 has some mild irritating potential to skin.
However, it is non-irritating with respect to EU and UN-GHS classification criteria.

Classification: not irritating
Executive summary:

In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to 0.5 mL undiluted Methacrylic acid ester 14.2 for 72 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.

The mean erythema score (average value of  the single scores (animals 1-6; erythema; intact skin, 24h and 72h)  was determined to be 1.00 out of 4 and the mean edema score 0.334 out of 4. Slight formation of edema could be observed in one of the test animals within 24 and 72 hours.

Methacrylic acid ester 14.2 is not a dermal irritant.

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

Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the  test values were reevaluated according to OECD criteria and test scores  (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

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