Octyl methacrylate

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.

NOTE:Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.