Reaction products of methacrylic acid and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Endpoint summary

Description of key information

The substance has no  acid-/alkaline reserve.
Skin irritation was studied according to OECD Guideline 404 and EU Method B.4. The substance obtained an overall irritation score of 0.17. Small Vinyl Ester is considered as not irritating to skin.
Eye irritation was studied according to OECD Guideline no. 437. The substance obtained an irritation similar to the negative control. The substance is considered as not irritating to eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

In vivo study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 h exposure to test substance on both shaved and shaved/abrased sites on the trunk of rabbits

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 h exposure to test substance on both shaved and shaved/abrased sites on the trunk of rabbits

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 6 adult albino-rabbits
- Source: Not specified
- Age at study initiation: Not specified (adult)
- Weight at study initiation: Average weight 2.5 kg
- Housing: Single cages
- Diet (e.g. ad libitum): Standard rabbit diet (Mümmel Z, Plange)
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: Not described

ENVIRONMENTAL CONDITIONS: Temperature, air humidity, Airchanges, and light/dark period were not specified in the report.

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml of undissolved test substance
- Application method: Applied on a gauze piece of 2.5 cm x 2.5 cm, fixated to the skin by Leukoplast non-irritating tape.
- Coverage of exposed skin areas: The entire back of the rabbit was covered in a fitted rubber cover/cloth to prevent evaporation of the test substance.

No vehicle or solvent was used for dissolving or diluting the test substance.

Duration of treatment / exposure:

24 hours

Observation period:

a total of 72 hours. Observation points at 24 hours after start of exposure (at removal of the gauze piece with the test substance) and after 72 hours.

Number of animals:

6

Details on study design:

On each rabbit four contact sites were present:
2 exposure sites with application of the test substance; 1 shaved site and 1 shaved/abrased site
2 untreated sites without application of test substance; 1 shaved site and 1 shaved/abrased site

TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
- % coverage: not described
- Type of wrap if used: Rubber wrapping

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not described
- Time after start of exposure: 24 h

SCORING SYSTEM: Grading of the skin reactions was performed evaluating the appearance of A) erythema and B) oedema, each on a scale from 0 to 4. The assessment was done comparing the reaction of the treated sites with the untreated sites scoring. The grading and scoring terms are in accord with OECD Guideline no. 404 and EU Method B.4

The score of each animal after 24 and 72 hours was logged for erythema and oedema on the shaved and shaved/abraded sites, respectively. For each animal an index (average score) for the reaction on the shaved or shaved/abraded sites was calculated as the arithmetic mean of the scores obtained at the respective sites.
The group index for the shaved or shaved/abraded skin was calculated as the arithmetic mean of the individual indexes. Finally, the acute skin irritation index of the test substance as an skin irritant was calculated as the combined mean of the group indexes.
Substances with acute skin irritation index below 2 was categorized as mild irritants, indexes between 2 and 5 as medium irritating, and indexes above 6 as very irritating. The categorization was in accord with recommendations from the Verband der Chemischen Industrie e.V., 13.5.1976, Frankfurt/Main, Germany.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 h

Score:

0.17

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: None

Irritant / corrosive response data:

See tables below

Other effects:

No

Table 1: Results:

			24 h	72 h
Animal 1	Shaved	Erythema	0	0
		Oedema	0	0
	Shaved/Abraded	Erythema	2	0
		Oedema	0	0
Animal 2	Shaved	Erythema	0	0
		Oedema	0	0
	Shaved/Abraded	Erythema	0	0
		Oedema	0	0
Animal 3	Shaved	Erythema	0	0
		Oedema	0	0
	Shaved/Abraded	Erythema	0	0
		Oedema	0	0
Animal 4	Shaved	Erythema	0	0
		Oedema	0	0
	Shaved/Abraded	Erythema	1	0
		Oedema	0	0
Animal 5	Shaved	Erythema	0	0
		Oedema	0	0
	Shaved/Abraded	Erythema	0	0
		Oedema	0	0
Animal 6	Shaved	Erythema	0	0
		Oedema	0	0
	Shaved/Abraded	Erythema	1	0
		Oedema	0	0

 

Table 2: Index of the acute skin irritation in shaved and shaved/abraded skin.

Irritation index shaved skin		Irritation index shaved/abraded skin
Animal No.	Average Index	Animal No.	Average Index
1	0	1	0.50
2	0	2	0.00
3	0	3	0.00
4	0	4	0.25
5	0	5	0.00
6	0	6	0.25
Average (X1)	0	Average (X2)	0.17
Overall irritation index (X1+ X2)	0.17

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Empfehlung des Verbandes der Chemischen Industrie e.V., 13/05/1976, 6 Frankfurt/Main, Germany.

Conclusions:

Small Vinyl Ester is categorized as "not irritating", with an overall irritation score of 0.17.

Executive summary:

The acute skin irritation/corrosion of Samall Vinyl Ester was tested in 6 albino-rabbits. Exposure for 24 h on shaved and shaved/abraded skin was performed using 0.5 ml of undiluted test substance on 2.5 cm x 2.5 cm gauze pieces covered with a fitted rubber cover, followed by observation of the skin reaction at 24 h and 72 h after start of the exposure test. For control 2 untreated shaved and shaved/abraded sites were observed concomitantly. Scoring of erythema and oedema reactions was performed in accord with current standards for grading of skin reactions. The experimental setup and procedure essentially followed the methods described in EU Methods B.4 (Dermal Irritation/Corrosion) and OECD guideline for Testing of Chemicals no. 404. The overall irritation score was 0.17. Thus, Small vinyl Ester is not a skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-03-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 437

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

not signed

Species:

other: Cow

Details on test animals or tissues and environmental conditions:

Eyes from cattles were used same days as they were slaughtered

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

1122 mg and 2484 mg

Duration of treatment / exposure:

Corneas were pre-incubated for 1 hour minimum at 32 C. Exposure time was 10 minutes. After exposure the cornea was rinsed to remove the test substance, and incubated for 2 hours for opacity measurement. The permeability was measured after 90 minutes incubation with sodium flourescein

Observation period (in vivo):

Corneas were incubated for 2 hours after exposure for opacity measurement, and 90 minutes for permeability testing

Number of animals or in vitro replicates:

3 eyes for negative, positive, positive on gauze pacth and the test substance, respectively.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Done after exposure time
- Time after start of exposure:

SCORING SYSTEM: Opacity was measured using an opacitometer (OP-KIT,MC2, Clermont, France)

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

other: Mean Opacity

Basis:

mean

Time point:

other: 2 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

other: Mean Permeability

Basis:

mean

Time point:

other: 90 minutes

Score:

0.011

Max. score:

0.015

Irritant / corrosive response data:

The In Vitro Irritancy score (IVIS) were calculated to 0.2. According to OECD Guideline 437 a substance has to induce a IVIS more or equal to 55.1 in order to be defined as corrosive or severe irritant. The positive controls induced a IVIS at 147 and 134, respectively, where as the negative control induced a IVIS at 0.0, conclusively the tested substance was similar to the negative control.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Small Vinyl Ester was tested for eye irritating potential and permeability, following OECD Guideline 437. The substance obtained values similar to the negative control, thus Small Vinyl Ester is considered a non irritant.

Executive summary:

Small Vinyl Ester was tested for eye irritating potential and permeability, following OECD Guideline 437. Data for the negative and positive controls showed validity of the test system. Small Vinyl Ester obtained values for both Opacity and Permeability, similar to the negative control. The obtained In Vitro Irritancy Score (IVIS) was 0.2, whereas according to the OECD Guideline 437, a substance has to obtain a IVIS at 55.1 or more in order to be defined as a corrosive or irritant. In can therefore be concluded that Small Vinyl Ester is not an irritant when tested according to OECD Guideline 437.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The substance did not show acid-/alkaline reserve capacity, cf. IUCLID section 4.23.

Skin irritation: The substance was tested for skin irritation potential, essentially following the methods described in EU Methods B.4 (Dermal Irritation/Corrosion) and OECD guideline for Testing of Chemicals no. 404.

Eye irritation: The substance was tested for eye irritating potential and permeability, following OECD Guideline 437. Data for the negative and positive controls showed validity of the test system.

Justification for classification or non-classification

Based on the findings of reliable skin irritation and eye irritation studies conducted on the substance, classification of the substance is not justified.