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Administrative data

Description of key information

Skin irritation: 
- irritating (EU method B.46; GLP) neat test substance, relative mean tissue viability after 60 minutes was 12.2% compared to negative control
Skin corrosion:
- not corrosive (OECD TG 431; GLP) neat test substance, relative mean tissue viability after 3 minutes was 97.7% compared to negative control / relative mean tissue viability after 60 minutes was 93.3% compared to negative control
Eye irritation:
- not irritating (OECD TG 405; GLP) neat test substance, slight to moderate ocular discharges at the 1 h observation; no other eye reactions were observed
- not irritating (HET-CAM; GLP) neat test substance, mean irritation score = 0.00

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-10-05 - 2010-10-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP
Qualifier:
according to guideline
Guideline:
other: EU B.46
Deviations:
yes
Remarks:
The test item was brought onto a nylon mesh on a microscope slide. Instead of incubating it for 30 minutes at 37 °C, the test item was incubated for 60 minutes at 37 °C. This deviation can be seen as uncritical.
Qualifier:
according to guideline
Guideline:
other: EU B.46
Deviations:
yes
Remarks:
The plate was not left to stand over night at room temperature. The plate was shaken for two hours and then the tissues were pierced with an injection needle.
Qualifier:
according to guideline
Guideline:
other: EU B.46
Deviations:
yes
Remarks:
Within the pre-tests and the main study 25±6 mg of the test item were used instead of 25mg. This deviation can be seen as uncritical since it was very difficult to weigh an exact amount of test item because of its resin appearance.
GLP compliance:
yes (incl. QA statement)
Species:
other: Human Skin Model
Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
60 min
Observation period:
60 min
Irritation / corrosion parameter:
other: other: % Formazan Production
Value:
12.2
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 min. Max. score: 50.0. Reversibility: no data. (migrated information)

For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:

 % Formazan Production

Designation

Test item

Positive Control

% Formazan production (Tissue 1)

12.6%

7.0%

% Formazan production (Tissue 2)

12.9%

7.3%

% Formazan production (Tissue 3)

11.0%

7.7%

% Formazan production Mean

12.2%

7.3%

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
The test item is considered irritant.
After the treatment, the relative absorbance values were decreased to 12.2%. This value is well below the threshold for irritation (50%).
The optical density of the negative control was well within the required acceptability crite-rion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 7.3% (required: For these reasons, the result of the test is considered valid.
Executive summary:

One valid experiment was performed. Three tissues of the human skin model EpiDermTM were treated with Epoxy half acrylate for 60 minutes.

25 mg of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size.

DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).

After the treatment with the test item, the relative absorbance values were reduced to 12.2 %. This value is well below the threshold for irritation potential (50%). Therefore, Epoxy half acrylate is considered as irritant in the Human Skin Model Test.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24th April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
30 May 2008
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 13-14 weeks
- Weight at study initiation: 2518 - 2820 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not given
- Humidity (%): not given
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
eyes were not rinsed after application
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed after application

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: hair loss and scabs were observed on the eye left of animal #1 from day 2 to 6 after instillation of test item, this was considered to be due to eye scratching
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The instillation of the test item into the eye resulted in slight to moderate ocular
discharges at the 1 hours observation (grade 1 in two animals and grade 2 in one animal). These effects were reversible: slight discharge was still observed at the 24 h observation in one animal, but was no longer evident after 48 h. No other eye reactions were observed.

Other effects:
No intercurrent deaths occurred during the course of the study. Hair loss and scabs were observed on the eye left of one animal (animal no. 1) from day 2 to 6 after instillation of test item, this was considered to be due to the eye scratching. No clinical signs were observed in any other animal during the study.
The body weight of the animals was within the range commonly recorded for this strain and age.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this study, Epoxy half acrylate was not irritating to the eye.
Executive summary:

In a primary eye irritation study according to OECD Guideline 405 (24 April 2002) and EU method B.5 (30 May 2008), 0.1 mL of Epoxy half acrylate (100% a.i.) was instilled into the conjunctival sac of the right eye of 3 female young adult New Zealand White rabbits. The eyes were not rinsed afterwards. Animals then were observed for up to 7 days.  Irritation was scored by the method of Draize.

The instillation of the test item into the eye resulted in slight to moderate ocular discharges at the 1 hours observation (grade 1 in two animals and grade 2 in one animal). These effects were reversible: slight discharge was still observed at the 24 h observation in one animal, but was no longer evident after 48 h. No other eye reactions were observed.

In this study, Epoxy half acrylate was not irritating to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

For the assessment of the skin irritation potential of Epoxy half acrylate an in vitro skin corrosion test and an in vitro skin irritation test are available.

 

In a dermal irritation study performed according to OECD Guideline 431 two tissues of the human skin model EpiDerm™ were treated with Epoxy half acrylate for three minutes and one hour, respectively. Averagely, 21.6 mg of the solid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8m KOH was used as positive control. After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were reduced to 97.7 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 93.3 %. This value, too, is well below the threshold for corrosion potential (15 %). Therefore, Epoxy half acrylate

is considered as not corrosive in the Human Skin Model Test.

 

In a dermal irritation study performed according to EU method B.46 three tissues of the human skin model EpiDermTM were treated with Epoxy half acrylate for 60 minutes. 25 mg of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size. DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%). After the treatment with the test item, the relative absorbance values were reduced to 12.2%. This value is well below the threshold for irritation potential (50%). Therefore, Epoxy half acrylate is classified as irritating to skin, Category 2 in the Human Skin Model Test.

 

Eye irritation

For the assessment of the eye irritation potential of Epoxy half acrylate an in vitro study (HET-CAM) and an in vivo study are available:

 

HET-CAM

This in vitro study was performed to assess the irritating potential of Epoxy half acrylate by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was five minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sulphate (1 % solution) and sodium hydroxide (0.1-N solution) were used as positive controls. Both positive controls induced severe irritation on the blood vessels. The negative control showed no irritation, the irritation score for the positive controls lay above the demanded threshold. The test item was tested pure. A mean irritation score of 0.00 was calculated, corresponding to a classification as not irritant.

 

In vivo study

In a primary eye irritation study according to OECD Guideline 405 (24 April 2002) and EU method B.5 (30 May 2008), 0.1 mL of Epoxy half acrylate

(100% a.i.) was instilled into the conjunctival sac of the right eye of 3 female young adult New Zealand White rabbits. The eyes were not rinsed afterwards. Animals then were observed for up to 7 days.  Irritation was scored by the method of Draize. The instillation of the test item into the eye resulted in slight to moderate ocular discharges at the 1 hours observation (grade 1 in two animals and grade 2 in one animal). These effects were reversible: slight discharge was still observed at the 24 h observation in one animal, but was no longer evident after 48 h. No other eye reactions were observed. In this study, Epoxy half acrylate was not irritating to the eye.

 

Respiratory irritation

No data on the respiratory irritation of Epoxy half acrylate are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.


Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study, GLP

Justification for selection of eye irritation endpoint:
OECD guideline study, GLP

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available reliable, relevant and adequate data, Epoxy half acrylate is classified as irritating to the skin (Category 2; H315: Causes skin irritation) according to regulation (EC) 1272/2008. The substance does not need to be classified for eye irritation.