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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: Guideline study with acceptable restrictions. Non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Deviations:
no
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
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethyltriglycol methacrylat
- Substance type: organic
- Physical state: liquid
- Analytical purity: as supplied by Röhm GmbH: purity in the test report not mentioned, commercial grade assumed > 98,5% ; colourless liquid
- pH: 6.8

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: New Zealand white rabbits,Schriever Kaninchenfarm, Bremervörde, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Single caging in battery of cages with paper roll disposal system
- Diet: ad libitum, Mümmel Z Kaninchenzuchkorn, Saniff Spezialfutter GmbH, Soest, Westfalen, Germany
- Water: ad libitum, quality as for humann consumption
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±2 °C
- Humidity (%): 50 - 85 %
- 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:
4 hour(s)
Observation period:
4h, 28h, 52 h and 76h post application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: the whole trunk of the animal was covered with a gummed bandage
- Type of wrap if used: rubber sleeve to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage, no wash off

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edema (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: 4 hours
Score:
0
Max. score:
4
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
Remarks:
out of 6 animals
Time point:
other: 4 hours
Score:
0
Max. score:
4
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 of 8 scores FDA (Draize), 1959,  evaluation according to OECD 404

Evaluation of the test results according to OECD404/GHS: only records for the shaved skin (not scarified) were considered  Erythema/ 28h     Erythema/76h  Oedema/28h  Oedema/76h
 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
 average (single scores: animal 1-6)  0 0  0  0
 Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  0  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    

 
    
Classification criteria according to the different classification systems:

EU-GHS:Category 1: Corrosive subcategories  

Corrosive in >= 1 of 3 animals (applies to authorities not using subcategories): Corrosive 
(only applies to some authorities)  
Subcategory    Exposure                       Observation 
------------------------------------------------------------ 
1A             <= 3 minutes                   <= 1 hour 
1B             > 3 minutes to <= 1 hour       <= 14 days 
1C             > 1 hour to <= 4 hours         <= 14 days 
------------------------------------------------------------  

A: Single harmonized corrosion category, using the results of animal testing. 
A: Corrosive is a test substance that produces destruction of skin tissue, 
namely, visible necrosis through the epidermis and into the dermis, in at least 
1 of 3 tested animals after exposure up to 4 hours duration. Corrosive reactions
are typified by ulcers, bleeding, bloody scrabs and, by the end of observation 
at 14 days, by discoloration due to bleaching of the skin, complete areas of 
alopecia and scars. Histopathologic determinations should be consided evaluate 
questionable lesions. 

Substances and/or mixtures are considered corrosive (Skin categorry 1) if it 
has a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/
acid  reserve suggests the substance or prepatration may not be corrosive 
despite the low or high pH value, then further testing needs to be carried out 
to confirm  this, preferably by use of an appropriate validated in vitro test.

Category 2:

(1) Mean value of >= 2.3 to < 4.0 for erythem/eschar or for oedema in at least 
    2 of 3 animals from gradings at 24, 48 and 72 hours after patch removal or, 
    if reactions are delayed, from grades on 3 consecutive days after the onset 
    of skin reactions, or 
(2) Inflammation that persits to the end of the observation period normally 14 
    days in at least 2 animals, particularly taking into account alopecia 
    (limited area), hyperkeratosis, hyperplasia, and scalling, or 
(3) In some cases where there is pronounced variability of response amoung 
    animals, with very definite positive effects related to chemical exposure in
    a single animal but less than the criteria above.

UN-GHS (additional category 3):

Category 3: Mild irritant (Applies to only some authorities for e.g. UN-GHS)  

Mean value of >= 1.5 to < 2.3 for erythem/eschar or for oedema from gradings in 
at least 2 of 3 tested animals from grades at 24, 48 and 72 hours or, if 
reactions are delayed, from grades on 3 consecutive days after the onset of skin
reactions (when not included in the irritant category above).  

According to the results of this dermal irritation study Ethyltriglycol 
methacrylate has to be classified as follows:

According to GefStoffV: non-irritant (4 hour exposition, no wash off the test 
                        substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and
                        oedema)
According to UN-GHS:Hazard category: None(Erythem 0, 4 hour exposition, no wash off the test substance)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ethyltriglycol methacrylate was not irritating in a primary skin irritation study in rabbits (4-hour occlusive application, no wash of the test substance). Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
According to the results of this dermal irritation study Ethyltriglycol methacrylate has to be classified as follows:
According to GefStoffV: non-irritant (4 hour occlusive application, no wash off the test substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema)
According to UN-GHS: Hazard category: None (4 hour occlusive application, no wash off the test substance) not irritating)
Executive summary:

In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to

0.5 mL undiluted Ethyltriglycol methacrylate for 4 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, 28h and 76h) was determined to be 0 out of 4 and the mean edema score was 0 out of 4.   

Remarks concerning the study result: The study for acute skin irritation/corrosion was performed according to OECD 404. The test values were evaluated according to OECD criteria and test scores (erythema, oedema) obtained for the  scarified skin were regarded as irrelevant. According to the results of this dermal irritation study Ethyltriglycol methacrylate has to be classified as follows: According to GefStoffV: non-irritant (4 hour application, no wash off the test substance) According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema) According to UN-GHS: Hazard category: None (4 hour application, no wash off the test substance) not irritating)

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