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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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).
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
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24+72 h
Score:
0
Max. score:
0
Remarks on result:
other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Any other information on results incl. tables

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

 

 

  1. 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: X+   X2= 0.37

 * = fragmentary value

Reevaluation according to OECD 404

 

 

Erythema

 

Edema

 

 

24h

72h

24h

72h

Tier 1

1

0

0

0

Tier 2

1

*

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

0,33333333

0

0

0

 

 

 

 

 

Total mean

0,16666667

 

0

 

 

Erythema

 

Edema

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
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 test substance for 24 h, occlusive. After 24 hours, 2 animals showed slight erythema (one of them died during the test not related to the test substance). Within 72 hours erythema were fully reversible. None of the 6 animals showed edema during the test.

According CLP criteria 2 -Hydroxyethyl methacrylate is not irritating to skin.