Bis[(3,4-epoxycyclohexyl)methyl] adipate

Endpoint summary

Description of key information

Skin Irritation/ Corrosion: Read-Across Substance

Based on these results, the test material 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.

Eye Irritation: Read-Across Substance

Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 June 1992 to 24 August 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

other: read-across target

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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: ad libitum except during the actual dosing period.
- Water: 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: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.

IN-LIFE DATES: From: 02 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 material was applied.
- Following application of the test material, the animals were placed in a restraining device for the 4 hour contact period.

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

SCORING SYSTEM: Draize scoring method

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

Application of 0.5 mL of the test material 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:

GHS criteria not met

Conclusions:

Based on the results of this study, the test material was not considered to be a skin irritant. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008 as the criteria were not fulfilled for erythema and oedema.

Executive summary:

In a study conducted by Myers et al, (1992), the test material was investigated for its potential to act as a skin irritant. The study was performed in accordance with the standardised guideline OECD 404, under GLP conditions.

The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5mL of the test material 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 material was 4 hours after which, as much excess test material 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 material 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.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Justification for type of information:

Read across to substance with the same functional groups.

Reason / purpose for cross-reference:

read-across source

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 June 1992 to 24 August 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Read across to substance with the same functional groups.

Reason / purpose for cross-reference:

other: read-across target

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- 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: diet was available ad libitum except during the actual dosing period.
- Water: 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: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod: 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:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

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 material 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.

Interpretation of results:

GHS criteria not met

Remarks:

Not eye irritating

Conclusions:

Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.

Executive summary:

In a study conducted by Myers et al., (1992),the test material was investigated for its potential to act as an eye irritant. The study was conducted in accordance with the standardised guideline OECD 405, under GLP conditions.

0.1mL of the test material was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test material 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.

Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Justification for type of information:

Read across to substance with the same functional groups.

Reason / purpose for cross-reference:

read-across source

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation/ Corrosion: Read-Across Substance

In a study conducted by Myers et al, (1992), the test material was investigated for its potential to act as a skin irritant. The study was performed in accordance with the standardised guideline OECD 404, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5mL of the test material 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 material was 4 hours after which, as much excess test material 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 material 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.

Eye Irritation: Read-Across Substance

In a study conducted by Myers et al., (1992), the test material was investigated for its potential to act as an eye irritant. The study was conducted in accordance with the standardised guideline OECD 405, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

0.1mL of the test material was placed into the conjunctival sac of one eye of each of 4 animals (2 per sex). The test material 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.

Under the conditions of this study, the test material was considered to be non irritating to eyes. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin and eye corrosion or irritation.