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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Pre-guideline study but comparable to guideline study. Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Principles of method if other than guideline:
Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials".
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glycoldimethacrylat
- Supplier: Evonik Industries AG, Darmstadt, Germany
- Purity: not metioned, but commercial grade is assumed

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: mean value 2,5 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
Amount / concentration applied:
undiluted 0.5 mL
Duration of treatment / exposure:
24 hour(s)
Observation period:
24h and 72h post application
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.42
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.42
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Only data of shaved skin have been used, data of shaved and scarified skin have not been used.

Any other information on results incl. tables

Overall primary irritation score (PDII): 0.42 of 8 scores FDA (Draize), 1959,  

re-evaluated according to OECD 404

Reevaluation of the test results according to OECD404/GHS: only records for the shaved skin (not scarified) were considered  Erythema/ 24h     Erythema/72h  Oedema/24h  Oedema/72h
 animal 1  1  0  0  0
 animal 2  0  0  0  0
 animal 3  1  0  0  0
 animal 4  1  0  0  0
 animal 5  1  0  0  0
 animal 6  1  0  0  0
 average (single scores: animal 1-6)  0,8333  0  0  0
 Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  0,42  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  0  
 Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  0,42    

Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the 
test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Ethylene glycol dimethacrylate was not irritating in a primary skin irritation study with in rabbits (24/72-hour occlusive application, no wash of the test substance, re-evaluated according to OECD 404).
Executive summary:

In a primary pre-guideline dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to 0.5 mL undiluted Ethyleneglycol dimethacrylate for 72 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.

The mean erythema score (average value of  the single scores (animals 1-6; erythema; intact skin, 24h and 72h)  was determined to be 0.42 out of 4 and the mean edema score 0 out of 4. Therefore Ethylene glycol dimethacrylate is

not a dermal irritant .

Therefore the test substance has not to be classified - according to GHS classification criteria and according to Draize-criteria - as non irritant for skin (GHS-hazard category: none).

Remarks concerning the study result: The study for skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.

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