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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets minimum scientific standards for a dermal irritation study and provides sufficient information for assessment
Justification for type of information:
Read across from the 2 Ethylhexyl methacrylate category member donor substance.
REPORTING FORMAT FOR THE CATEGORY APPROACH
see attached category document
PM_Lower Alkyl (C1-C8) Methacrylates
This is a category (C1-C8 Lower Alkyl Methacrylates) with clear trends in the physicochemical properties of its members, related to molecular weight, molecular size and hydrophilicity.
The degree of skin irritation observed in animals with the C1-C8 methacrylate esters is slight on short exposure to moderate on prolonged exposure of 24 hours, in the rabbit. In humans there is evidence
from Nyquist et al. (1958) that 5% MMA in paraffin and olive oil caused erythema and eczematous reactions. Although there are no relevant, documented data on human experience with the other esters it
is likely that they will be comparable to MMA. For 2-EHMA, a new in vitro study showed the low skin irritation potential with clear negative results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Labeling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Octyl methacrylate
EC Number:
218-465-5
EC Name:
Octyl methacrylate
Cas Number:
2157-01-9
Molecular formula:
C12H22O2
IUPAC Name:
octyl 2-methylprop-2-enoate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
24 and 72-h post dosing
Number of animals:
6
Details on study design:
Six NZ White rabbits were restrained in stocks and the fur removed by clipping. Half of the exposed area was abraded and the other half remained intact. 0.5 ml(vol) of test compound was applied to the shaved intact and abraded skin sites and covered with surgical gauze. The area  was then wrapped with impervious tape and a stockinette sleeve.  Test material remained in contact for 24 hrs and then removed.  Irritation  scores were determined at 24 and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
erythema score
Basis:
mean
Time point:
other: 24+72h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: shaved skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24+72h
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: shaved skin
Irritation parameter:
erythema score
Remarks:
erythema score
Basis:
mean
Time point:
other: 24+72h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24+72h
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: scarified skin
Irritant / corrosive response data:
The reactions displayed at the first reading interval ranged from barely perceptible to moderate reddening and swelling of the skin, at both intact and abraded sites. Evidence of irritation persisted to the end of the test period in each animal. Examples of a general increase in turgor, discolouration and induration were also identified in this study.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Executive summary:

The cutaneous irritation that could be induced by 2-ETHYLHEXYL METHACRYLATE was evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register (USA) -29 F.R. 13009, 1964.

2-ETHYLHEXYL METHACRYLATE was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours.

Barely perceptible to moderate reddening and swelling of the skin were exhibited 24 hours following application. Reactions persisted to 72 hours. For the intact skin, the mean scores over 24 and 72 h were 1.9 and 2.2 for erythema and oedema, respectively.

Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as an slight irritant when applied 24 hours to the rabbit skin.

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