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Description of key information

Two skin irritation/corrosion studies and one eye irritation/corrosion study are available.  All three studies used rabbits as the test species, specifically the New Zealand White strain.  One of the skin irritation studies was conducted according to OECD guideline 404.  The eye irritation study was conducted in accordance with OECD Guideline 405.  No indications of skin or eye irritation were observed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Remarks:
Rabbit study, enabling assessment of skin irritation and corrosion
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 2nd 1992 - August 24th 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary guideline study, compliant wih the relevant guidelines.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Number of animals used was in excess of guideline minimum
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Cyracure UVR-6110
- Substance type: Not documented
- Physical state: Colourless, transparent, slightly viscous liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: 100% 3,4-epoxy cyclohexyl methyl-3,4 epoxy cyclohexyl
carboxylate
- Purity test date: Not documented
- Lot/batch No.: 55-61
- Stability under test conditions: Not documented
- Storage condition of test material: Stored at room temperature.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. (Denver, PA).
- Age at study initiation: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg (males) and 2.6 to 3.5 kg (females)
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in.).
- Diet (e.g. ad libitum): AGWAY PROLAB Animal Diet High Fibre Rabbit was available ad libitum except during the actual dosing period.
- Water (e.g. ad libitum): Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.1 - 21.6°C
- Humidity (%): 40 - 60%
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.

IN-LIFE DATES: From: 2 June 1992 To: 16 June 1992
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml


Duration of treatment / exposure:
4 hour exposure period.
Observation period:
14 days
(Animals were observed at 1, 24, 48 and 72 hours and 7 and 14 days)
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: Not documented - test site was circa 2.5 x 2.5 cm
- Type of wrap if used: Polyethylene sheeting was placed loosely over the gauze patch on which the test substance was applied.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): As much excess test substance was removed as possible
- Time after start of exposure: Following the 4 hour exposure period.

SCORING SYSTEM: Draize scoring method
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
ca. 1.35
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: No irreversible tissue destruction noted.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Application of 0.5 ml of CYRACURE UVR-6110 to covered rabbit skin for a 4-hour contact period produced minor erythema on 6 of 6 rabbits. Minor transient oedema was produced on 3 animals. There was no oedema present on any animal by 2 days. Erythema subsided on all rabbits within 14 days.
Other effects:
There was no irreversible tissue destruction noted.

Using the EU criteria for assessing skin irritation the mean score for 24, 48 and 72 hours for erythema was 0.833 and for oedema was 0.17. Recovery was complete within 14 days for erythema and within 2 days for oedema.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the test substance, CYRACURE UVR-6110 was not considered to be a skin irritant. As a result of this, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC as the criteria were not fulfiled for erythema and oedema.
Executive summary:

In a study conducted by Myers et al, (1992), the test substance, CYRACURE UVR-6110 was investigated for its potential to act as a skin irritant. The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5ml of the test substance was applied via a gauze patch. Polyethylene sheeting was wrapped around the test site to create an impermeable barrier. The contact period with the test substance was 4 hours after which, as much excess test substance as possible was removed.

The modified primary irritation score was 1.35. Minor erythema was observed on all 6 rabbits directly after the 4 hour contact period. Minor transient oedema was evident on 3 animals but it had subsided fully by day 2. Erythema had subsided fully within 14 days. Based on these results, the test substance was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 2nd 1992 to August 24th 1992.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary guideline study.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Cyracure UVR-6110
- Substance type: epoxy resin
- Physical state: Colourless, transparent, slightly viscous liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: 100% 3,4-epoxy cyclohexyl methyl-3,4 epoxy cyclohexyl
carboxylate
- Purity test date: Not documented
- Lot/batch No.: 55-61
- Expiration date of the lot/batch: Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: Stored at room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. (Denver, PA).
- Age at study initiation: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg or 2.6 to 3.5 kg for males and females respectively
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in).
- Diet (e.g. ad libitum): AGWAY PROLAB Animal Diet High Fibre Rabbit was available ad libitum except during the actual dosing period.
- Water (e.g. ad libitum): Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.1 - 21.6°C
- Humidity (%): 40 - 60%
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.

IN-LIFE DATES: From: June 2, 1992 To: June 11, 1992
Vehicle:
not specified
Controls:
other: the untreated eye of each animal served as the control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
Duration of treatment / exposure:
9 days
Observation period (in vivo):
9 days
(Animals were observed at 1, 24, 48 and 72 hours and at 7 and 9 days following instillation)
Number of animals or in vitro replicates:
4 rabbits (2 males and 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented

SCORING SYSTEM: Draize (1959) scoring method.

TOOL USED TO ASSESS SCORE: fluorescein staining performed on day 1 and at each subsequent examination days.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other:
Remarks:
No effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
> 0 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritant / corrosive response data:
A volume of 0.1 ml of test substance instilled into rabbit eyes produced no corneal injury or iritis in any of 4 rabbit eyes dosed. Minor conjunctival irritation was observed in all 4 rabbits within 1 hour. The dosed eye of 1 rabbit healed by 48 hours. The 3 remaining rabbits had a normal ocular appearance within 72 hours to 9 days.
Other effects:
No additional effects observed.

No additional information

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following instillation of 0.1ml of the test substance into the eyes of rabbits, it was determined that CYRACURE UVR-6110 was not irritating to the eyes. Based on these results, the test substance does not require classification according to Regulation EC No. 1272/2008 as it does not meet the criteria for classification outlined. None of the mean scores for corneal iridial or conjunctival reactions exceeded the threshold values requiring classification inaccordance wit Directive 67/548/ EEC, as amended.
Executive summary:

In a study conducted by Myers et al., (1992),the test substance, CYRACURE UVR-6110 was investigated for its potential to act as an eye irritant. 0.1ml of the test susbtance was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test substance was not removed so the exposure period was 9 days. Following exposure, no corneal injury or iritis in any of 4 rabbit eyes dosed was observed. Minor conjunctival irritation was observed in all 4 animals within one hour, with the dosed eye of 1 rabbit healing by 24 hours and the 3 remaining rabbits had a normal appearance within 72 hours to 9 days. Based on these results, the test substance was considered to be non irritating to eyes. As a result of this, the test substance does not require classification according to Regulation EC No. 1272/2008.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation/Corrosion:

In a study conducted by Buch and Gardner (1981), a single dermal application of 0.5ml Celloxide 2021 was applied to intact and abraded test sites on the shaven dorsum of six New Zealand White rabbits. The period of contact time was 23 hours, after which the test material was removed by gentle washing and the skin reactions were observed for the following 14 days. Under the conditions of this assessment, Celloxide 2021 elicited a Primary Irritation Index of zero. Based on these results, the test material was classified as "mildly irritating" to skin- the lowest grade assigned under the classification used for this study.

In a study conducted by Myers et al, (1992), the test substance, CYRACURE UVR-6110 was investigated for its potential to act as a skin irritant. The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5ml of the test substance was applied via a gauze patch. Polyethylene sheeting was wrapped around the test site to create an impermeable barrier. The contact period with the test substance was 4 hours after which, as much excess test substance as possible was removed.

The modified primary irritation score was 1.35. Minor erythema was observed on all 6 rabbits directly after the 4 hour contact period. Minor transient oedema was evident on 3 animals but it had subsided fully by day 2. Erythema had subsided fully within 14 days. Based on these results, the test substance was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.

The key study was considered to be the study conducted by Myers et al, 1992, as it was conducted according to GLP and was compliant with the Guidelines. The study conducted by Buch et al (1981), was considered as supporting information as the animals skin was abraded prior to application of the test substance.

Eye Irritation/Corrosion:

In a study conducted by Myers et al., (1992),the test substance, CYRACURE UVR-6110 was investigated for its potential to act as an eye irritant. 0.1ml of the test substance was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test substance was not removed so the exposure period was 9 days.

Following exposure, no corneal injury or iritis in any of 4 rabbit eyes dosed was observed. Minor conjunctival irritation was observed in all 4 animals within one hour, with the dosed eye of 1 rabbit healing by 24 hours and the 3 remaining rabbits had a normal appearance within 72 hours to 9 days. Based on these results, the test substance was considered to be non-irritating to eyes. As a result of this, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC as it does not fulfil the criteria to warrant a classification.

Justification for classification or non-classification

Skin Irritation/Corrosion:

The test substance used in the key study, CYRACURE UVR-6110, was not classified as a skin irritant as it did not fulfil the criteria as detailed in Regulation EC No. 1272/2008 or Directive 67/548/EEC.

Eye Irritation/Corrosion:

The test substance used in the study, CYRACURE UVR-6110 did not induce any irritant effects and so, was not classified according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.