Fatty acids, C16-18 (even numbered, C18 unsaturated), 2-ethylhexyl esters, epoxidized

Endpoint summary

Description of key information

In vivo skin and eye irritation tests are performed with the test substance. Under the conditions of these studies, the test item exhibited neither an eye- nor a skin irritation potential.

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:

02.1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

Occlusive treatment.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted 2002)

Deviations:

yes

Remarks:

Occlusive treatment. Treatment of 4 animals. No data on purity of test substance.

GLP compliance:

yes

Specific details on test material used for the study:

- Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid

Species:

rabbit

Strain:

other: Kleinrusse Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult
- Sex: male
- Weight at study initiation: 2.31 kg (mean)
- Housing: single housing
- Diet: Diet 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod: 12 hrs dark / 12 hrs light

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch with test substance, covered with a plastic film and fixed with adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM:
Draize scheme

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Calculated from the raw data.

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Calculated from the raw data.

In the original assessment of the study a primary irritation index of 0.5 based on readings after 24, 48, and 72 hours was reported. (PII = Sum of all reactions/(Number of animals*Number of reading time points)

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusion, the test substance showed no skin irritating potential

Executive summary:

In a study according to OECD TG 404 (adopted 1981, GLP), the skin irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. The rabbits were treated with 0.5 mL of the undiluted test substance for 4 hours under occlusive conditions. Readings were performed 1, 24, 48, and 72 hours after application. An erythema mean score of 0.5 was calculated from the results after 24, 48, and 72 hours. The findings were fully reversible within 72 h. The corresponding edema score was 0. In conclusion, the test substance showed no skin irritating potential

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

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:

4 Mar 1988 - 11 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 1987)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 2002)

Deviations:

yes

Remarks:

Use of 4 animals and no data on purity of test substance.

GLP compliance:

yes

Specific details on test material used for the study:

- Chemical name: Epoxystearinsaeure-2-ethylhexylester
- Physical state: colorless liquid

Species:

rabbit

Strain:

other: Kleinrusse Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Sex: male
- Age at study initiation: adult
- Weight at study initiation: 2.42 kg (mean)
- Housing: single housing
- Diet: Altromin diet 2023, Altromin GmbH, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod: 12 hrs dark / 12 hrs light

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM:
Draize scheme

READINGS:
1, 6, 24, 48, and 72 hours after application

TOOL USED TO ASSESS SCORE:
fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.08

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Conjunctivae findings were observed at 1, 6, and 24 h after treatment. 3/4 animals had a score of 1, 1/4 animals had a score of 2 after 1 hour. After 6 h 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance showed no eye irritating potential

Executive summary:

In a study according to OECD TG 405 (adopted 1987, GLP), the eye irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. 0.1 mL of the undiluted test substance was instilled into the rabbits eye and no washing was performed. Readings were performed 1, 6, 24, 48, and 72 hours after application. Conjunctivae findings were observed at 1, 6, and 24 h after treatment, where 3/4 animals had a score of 1 and 1/4 animals had a score of 2 after 1 hour. After 6 h, 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

For the test substance in vivo data on skin and eye irritating properties are available. The concerning studies are summarized below.

Skin irritation in vivo

In a study according to OECD TG 404 (adopted 1981, GLP), the skin irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. The rabbits were treated with 0.5 mL of the undiluted test substance for 4 hours under occlusive conditions. Readings were performed 1, 24, 48, and 72 hours after application. An erythema mean score of 0.5 was calculated from the results after 24, 48, and 72 hours. The findings were fully reversible within 72 h. The corresponding edema score was 0. In conclusion, the test substance showed no skin irritating potential (Henkel 1988).

Eye irritation in vivo

In a study according to OECD TG 405 (adopted 1987, GLP), the eye irritating potential of the test substance was observed in 4 male Kleinrusse rabbits. 0.1 mL of the undiluted test substance was instilled into the rabbits eye and no washing was performed. Readings were performed 1, 6, 24, 48, and 72 hours after application. Conjunctivae findings were observed at 1, 6, and 24 h after treatment, where 3/4 animals had a score of 1 and 1/4 animals had a score of 2 after 1 hour. After 6 h, 2/4 animals had a score of 1, whereas no findings were observed in the other 2 animals. After 24 h a score of 1 was observed in 1/4 animals. No findings were observed in the other 3 animals. No conjunctivae findings were observed at later time points. No iris or corneal findings and chemosis were observed in any animal at any time point. Discharge (score 2) was observed in 4/4 animals 1 hour after treatment but was fully reversible within 6 hours. In conclusion, the test substance showed no eye irritating potential (Henkel 1988).

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. A GLP-compliant OECD 405 study is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008,as amended for the fourteenth time in Regulation (EC) No. 2020/217.