Methacrylic acid, monoester with propane-1,2-diol

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:

test procedure in accordance with national standard methods with acceptable restrictions

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 by staff of the Division of Pharmacology, FDA acc. to Draize

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:

Methacrylic acid, monoester with propane-1,2-diol

EC Number:

248-666-3

EC Name:

Methacrylic acid, monoester with propane-1,2-diol

Cas Number:

27813-02-1

Molecular formula:

C7H12O3

IUPAC Name:

1-hydroxypropan-2-yl 2-methylprop-2-enoate; 2-hydroxypropyl 2-methylprop-2-enoate

Test material form:

liquid

Details on test material:

The chemical 2-propenoic acid, 2-methyl-, monoester with 1,2-propanediol (CAS No. 27813-02-1) consists of two isomers. This occurs due to the method of industrial production, which is usually either the reaction between methacrylic acid and propylene oxide, or methacrylic acid esterification of 1,2-propanediol. The predominant isomer is the secondary alcohol 2-propenoic acid, 2-methyl, 2-hydroxypropyl ester, which is assigned the CAS No. 923-26-2, and the isomer 2-propenoic acid, 2-methyl, 2-hydroxy- 1-methylethyl ester, the other chemical in this group, for which CAS 4664-49-7 is assigned. The purification of the two isomers requires extensive effort and it is supposed no such effort has been taken during data collection otherwise noted. Therefore toxicity information for both CAS No. 923-26-2 and CAS No. 27813-02-1 is considered to be applicable to both chemicals..

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: 0,005 to 1 % 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, #2, #3, #4, #5, #6

Time point:

other: 24/72h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

other: 24/72h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

0/6 animals had erythema or edema after 72 hours. Mean scores for erythema and edema after 24 and 72 hrs were 0.

Any other information on results incl. tables

 

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

 

1. Primary irritation index of the shaved skin

 

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

 

 

2. Primary irritation index of the shaved/scarifized skin

 

Animal No.	Primary irritation index
1	0.00
2	1.00
3	0.50
4	0.00
5	0.00
6	0.50
X2	0.33

 

Total index: X₁ +   X₂= 0.33

 

 

• = fragmentary value

 

 

Reevaluation according to OECD 404

 

	Erythema		Edema
	24h	72h	24h	72h
Animal  1	0	0	0	0
Animal  2	0	0	0	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	0	0	0
Total mean	0		0
	Erythema		Edema

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: not irritating

Executive summary:

2-Hydroxypropyl 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 New Zealand White rabbits were exposed to undiluted HPMA on the shaved and shaved + scarified skin under occlusive conditions for 24 hours. The  observation time was  72 hrs. No erythema or edema were observed in any animal after 24 and 72 hrs at the shaved skin.

Therefore in this study 2-hydroxypropyl methacrylate is not irritating to skin according to EU regulation 1271/08 and UN-GHS requirements.