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

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-{4-[2-(4-{2-hydroxy-3-[(2-methylprop-2-enoyl)oxy]propoxy}phenyl)propan-2-yl]phenoxy}propyl 2-methylprop-2-enoate

EC Number:

701-308-4

Cas Number:

36425-15-7

Molecular formula:

n/a

IUPAC Name:

2-hydroxy-3-{4-[2-(4-{2-hydroxy-3-[(2-methylprop-2-enoyl)oxy]propoxy}phenyl)propan-2-yl]phenoxy}propyl 2-methylprop-2-enoate

Details on test material:

The report describes 2,2'-Bis-4(3'-methacryloyloxy-2'hydroxy)propoxyphenyl propane as a colourless, clear, viscous fluid produced and delivered by the sponsor of the study (Röhm GmbH, Chemische Fabrik).
The undiluted test substance was used the test.
No data on chemical or physical characteristics of the test substance is described in the report.

Test animals

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.

Test system

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.

Results and discussion

In vivo

Results

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

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.