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Diss Factsheets

Administrative data

Description of key information

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: no study conducted

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 Oct 2012 - 09 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: Japanese White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co. Ltd
- Age at study initiation: 21 weeks
- Weight at study initiation: 3.81 kg
- Housing: metal bracket-type cages (350 W x 500 D x 350 H, mm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 44 - 60%
- Air changes (per hr): 8 -13 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/section
- Concentration (if solution): according to test guideline

VEHICLE
- Amount(s) applied: 0.5mL

Duration of treatment / exposure:
4 hours
Observation period:
1 hr, 24 hr, 48 hr, 72 hr, and 4 days
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton swab soaked with tepid water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1 hr, 24 hr, 48hr, 72hr, 4 days

SCORING SYSTEM: macroscopic observation of the skin
- Method of calculation: according to the globalyl harmonised system of classification and labelling of chemicals (GHS) criteria for skin corrosion/irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 0 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48hr, 72hr, 4 days
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 0 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1hr, 24,hr, 48hr, 72hr, 4 days
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
At the sites treated with Methyl 2-(Allyloxymethyl)Acrylate, very slight erythema (score 1) accompanied by very slight oedema (score 1) was noted immediately after patch removal.

This irritative change worsened over time, and severe erythema (beet-redness) to eschar formation preventing grading of erythema (score 4) accompanied by severe oedema (score 4), indicating hemorrhagic eschar, was noted by 72 hours after patch removal.

This change was also found 4 days after patch removal.

Methyl 2-(Allyloxymethyl)Acrylate was classified as category 1 according to the the GHS criteria for skin irritation/corrosion.
On the basis of these results, it was concluded that Methyl 2-(Allyloxymethyl)Acrylatehas skin corrosion potential.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A Skin Irritation/ Corrosion study (Safety Research Institute for Chemical Compounds, 2013, Study SR12174) was conducted to determine the skin corrosion potential of 2-(Allyloxymethyl) acrylic acid methyl ester. The study was performed according to OECD test guideline 404 and in compliance with GLP.

The effects of dermal exposure to 2-(Allyloxymethyl) acrylic acid methyl ester were investigated in one New Zealand White rabbit. A single occlusive application of 2-(Allyloxymethyl) acrylic acid methyl ester for four hours elicited a dermal reaction ranging from well-defined to moderate to severe in the animal tested. No further animals were tested based on the reaction to 2-(Allyloxymethyl) acrylic acid methyl ester after the first testing. Very slight erythema (score 1) accompanied by very slight oedema (score 1) was noted immediately after patch removal at all sites tested with 2-(Allyloxymethyl) acrylic acid methyl ester. This irritative change got worse over time. Severe erythema (beet-redness) to eschar formation preventing grading of erythema (score 4) accompanied by severe oedema (score 4) was observed 48 and 72 hours after patch removal. This change was noted also noted 4 days after patch removal.

 

On the basis of this observation 2-(Allyloxymethyl) acrylic acid methyl ester is considered to be corrosive to skin and meets the criteria for classification as corrosive to skin.

According to Commission Regulation 1272/2008 table 3.2.1 CLP Annex I, 2-(Allyloxymethyl) acrylic acid methyl ester meets category 1.

 

An Eye Irritation study was not conducted to assess the effect of the instillation of 2-(Allyloxymethyl) acrylic acid methyl ester on the basis that it was found to have a skin corrosion potential

 

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: no study conducted

Justification for classification or non-classification

On the basis of the above studies, 2-(Allyloxymethyl) acrylic acid methyl ester meets the criteria for classification as corrosive to skin.

According to Commission Regulation 1272/2008, 2-(Allyloxymethyl) acrylic acid methyl ester is classified as corrosive to skin, Category 1; the related Signal word is "Danger", and the Hazard Statement is "H314: Causes severe skin burns and eye damage".