2-hydroxyethyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959)

Principles of method if other than guideline:

Method: Appraisal of the safety of chemicals in foods, drugs and cosmetics by the Staff of the Division of Pharmacology, FDA, Hautgiftigkeit nach Draize (1959)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxyethyl methacrylate

EC Number:

212-782-2

EC Name:

2-hydroxyethyl methacrylate

Cas Number:

868-77-9

Molecular formula:

C6H10O3

IUPAC Name:

2-hydroxyethyl methacrylate

Test material form:

liquid

Specific details on test material used for the study:

Supplier: Röhm GmbH, Darmstadt, Germany
Purity: not specified in the report.
Company data in the years of the report: 0,071 bis 0,91 % methacrylic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (average)
- Housing: individual cages
- Diet: rabbit standard diet (Höing 222)
- Water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -1 (max. limitation)
- Humidity (%): 50-60
- Photoperiod ( hrs light): 12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, shaved and scarified

Vehicle:

unchanged (no vehicle)

Controls:

other: as a contol 2 areas of the treated animals were also shaved ans scrarified but remained untreated

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume): 0.5 ml

Duration of treatment / exposure:

24 hour(s)

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: rubberized cloth

CONTROL.
- as a contol 2 areas of the treated animals were also shaved and scrarified but remained untreated

REMOVAL OF TEST SUBSTANCE
- Washing : no wahing was done


SCORING SYSTEM:
1. Erythema and scars formation
no erythema 0
very slight erythema 1
clear erythema 2
moderate to severe erythema 3
severe erythema (scarlet red) 4
and slightly scars formation

2. Edema formation
no edema 1
very slight edema 2
moderate edema (thickness ca. 1mm) 3
severe edema (thickness more than 4
1mm, large than the edge of the
contact)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean 24+72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Remarks on result:

other: before end of test, animal died, not treatment related

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24+72 h

Score:

0

Max. score:

4

Remarks on result:

other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).

Irritant / corrosive response data:

2/6 animals showed mean response scores for erythema of 0.5 and 1, respectively after 24 and 72 hrs or 24 hrs, respectively. Mean erythema scores in 4/6 animals were 0.
No edema scores were detected in 6/6 animals.

Any other information on results incl. tables

Original data of the test report:

Animal Nr.			Scores (24 h)	Scores (72 h)
1	shaved	Erythema and scras formation	1	0
		Edema formation	0	0
	shaved/scarified	Erythema and scras formation	2	1
		Edema formation	1	0
2	shaved	Erythema and scras formation	1	*
		Edema formation	0	*
	shaved/scarified	Erythema and scras formation	0	*
		Edema formation	0	*
3	shaved	Erythema and scras formation	0	0
		Edema formation	0	0
	shaved/scarified	Erythema and scras formation	1	0
		Edema formation	1	0
4	shaved	Erythema and scras formation	0	0
		Edema formation	0	0
	shaved/scarified	Erythema and scras formation	0	1
		Edema formation	0	0
5	shaved	Erythema and scras formation	0	0
		Edema formation	0	0
	shaved/scarified	Erythema and scras formation	0	0
		Edema formation	0	0
6	shaved	Erythema and scras formation	0	0
		Edema formation	0	0
	shaved/scarified	Erythema and scras formation	0	0
		Edema formation	0	0

*= animal died prio to the end of the test, death not attributed to the treatment with the substance

 

 

1. Primary irritation index of the shaved skin

 

Animal No.	Primary irritation index
1	0.25
2	0.25*
3	0.00
4	0.00
5	0.00
6	0.08
X1	0.08

 

 

2. Primary irritation index of the shaved/scarified skin

 

Animal No.	Primary irritation index
1	1.00
2	0.00*
3	0.50
4	0.25
5	0.00
6	0.00
X2	0.29

 

Total index: X₁ +   X₂= 0.37

 * = fragmentary value

 

Reevaluation according to OECD 404

 

	Erythema		Edema
	24h	72h	24h	72h
Animal 1	1	0	0	0
Animal 2	1	*	0	*
Animal 3	0	0	0	0
Animal 4	0	0	0	0
Animal 5	0	0	0	0
Animal 6	0	0	0	0
Mean	0,33333333	0	0	0
Total mean	0,16666667		0
	Erythema		Edema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: not irritating

Executive summary:

2 -Hydroxyethyl methacrylate was tested in a primary skin irritation test to rabbits according to "Appraisal of the safety of chemicals in food, drugs and cosmetics by the Staff of the Division of Parmacology, FDA, 1959 in food, drugs and cosmetics". 6 animals were treated with the undiluted test substance for 24 h, occlusive. After 24 hours, 2 animals showed slight erythema at the shaved intact skin (one of them died during the test not treatment related). Within 72 hours erythema were fully reversible. None of the 6 animals showed edema during the test.

Therefore in this study hydroxyethyl methacrylate is not irritating to skin according to EU regulation 1271/08 and UN-GHS requirements.