Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0

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:

other: 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 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:

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

Details on test material:

IUCLID4 Test substance: as prescribed by 1.1 - 1.4

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

Results 2

Irritation parameter:

edema score

Basis:

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

Time point:

other: 2472h

Score:

0

Max. score:

4

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
Tier 1	0	0	0	0
Tier 2	0	0	0	0
Tier 3	0	0	0	0
Tier 4	0	0	0	0
Tier 5	0	0	0	0
Tier 6	0	0	0	0
Mean	0	0	0	0
Total mean	0		0
	Erythema		Edema

 

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

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". .Therefore Hydroxypropyl methacrylate is not irritating according to EU-CLP requirements.