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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study 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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich
EC Number:
288-509-6
EC Name:
2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich
Cas Number:
85736-97-6
IUPAC Name:
85736-97-6
Constituent 2
Reference substance name:
Isotridecyl methacrylate
EC Number:
304-180-4
EC Name:
Isotridecyl methacrylate
Cas Number:
94247-05-9
Molecular formula:
C17H32O2
IUPAC Name:
Isotridecyl methacrylate
Details on test material:
- Supplier: Evonik Röhm GmbH, D-64293 Darmstadt, Germany
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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
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
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:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1 - 72 h
Score:
1.67
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
1.33
Max. score:
4
Remarks on result:
other: In 1 animal not fully reversible within 8 days

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:
not irritating
Remarks:
Migrated information 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 an acute dermal irritation / corrosion study (OECD 404, GLP) New Zealand White rabbits (strain: no data) were dermally exposed to undiluted 0.5 g Isotridecyl methacrylate for 4 hours. Animals then were observed for 8 or 9 days.

The mean erythema score (average value of the single scores (animals 1-3; erythema; intact skin, 24h, 48 h and 72h)  was determined to be 0.44 out of 4 and, accordingly, the mean edema score 1.33 out of 4. 

 

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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