2-ethylhexyl 3,5,5-trimethylhexanoate

Endpoint summary

Description of key information

The substance was non-irritating to eyes and skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harveys Lake, Pennsylvania.
- Housing: during the test period the animals were individually housed in stainless steel wire bottomed cages in an environmentally controlled room
- Diet (e.g. ad libitum): Purina rabbit pellets ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

other:

Amount / concentration applied:

0.5 g of the test material

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

six healthy rabbits

Details on study design:

Six healthy rabbits were each uniquely identified and then prepared by clipping the trunk free of hair. Two 2.5 cm² square patches were placed under over intact skin and abraded skin on each rabbit. Five-tenths of a milliliter or 0.5 g of the test material was placed under each patch. The entire trunk of the animal was wrapped with a rubberized elastic cloth to retard evaporation and as an aid in maintaining test patch position. Rabbits were placed in neck collars and returned to their individual cages. Collars were removed after 24 hours. All test sites were wiped with a cloth to prevent further exposure. Skin lesions were evaluated at 24 and 72 hours and scored.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

intact (left)

Time point:

other: 24 hrs

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hrs

Remarks on result:

other: Individual scores not available from report

Irritation parameter:

edema score

Basis:

mean

Remarks:

intact (left)

Time point:

other: 24 hrs

Score:

0

Max. score:

4

Remarks on result:

other: Individual scores not available from report

Irritation parameter:

erythema score

Basis:

mean

Remarks:

abraded(right)

Time point:

other: 24 hrs

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hr

Remarks on result:

other: Individual scores not available from report

Irritation parameter:

edema score

Basis:

mean

Remarks:

abraded(right)

Time point:

other: 24 hrs

Score:

0

Max. score:

4

Remarks on result:

other: Individual scores not available from report

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24-72hours

Score:

ca. 0.17

Max. score:

8

Remarks on result:

other: Individual scores not available from report

Irritant / corrosive response data:

Test article was found to cause the primary irritation erythema score of 0.33 at 24 hours, but these effects were fully reversible within 72 hours.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the available data, the test article is considered to be a non-primary irritant to the skin.

Executive summary:

The primary skin irritation potential of the test article was investigated. Two 2.5 cm² square patches were placed under over intact skin and abraded skin on each rabbit. Five-tenths of a milliliter or 0.5 g of the test material was placed under each patch. The scoring of skin reactions was performed at 24 and 72 hours after removal of the collars. All test sites were wiped with a cloth to prevent further exposure. Skin lesions were evaluated at 24 and 72 hours and scored.

Under the conditions of this experiment, the test material 2-ethylhexyl 3,5,5-trimethylhexanoate was found to cause a primary irritation score of 0.33 erythema after adiministration of 24 hours when applied to healthy intact and abraded rabbit skin, being fully reversible within 72 hours. Thus, the substance is considered being non-irritant to skin.

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:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline test wihout GLP

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harveys Lake, Pemnsylvania.
- Housing: Individually housed in stainless steel wire bottomed cages in an environmentally controlled room
- Diet (e.g. ad libitum): Purina rabbit pellets ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml of test material

Duration of treatment / exposure:

The upper and lower lids of one eye were gently held together for one second, before releasing; the eyes were not rinsed/washed afterwards.

Number of animals or in vitro replicates:

six healthy young, adult rabbits

Details on study design:

Six healthy young adult albino rabbits exhibiting no ocular defects or corneal defects were selected for testing. The test animals were each uniquely identified. One-tenth of a milliliter of the test material was placed on the everted lower lid of one eye of each rabbit. The upper and lower lids were gently held together for one second before releasing, to prevent loss of the test material. The contra lateral eye of each rabbit remained untreated and served as a control. Ocular lesions were evaluated by the method of Draize.

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

110

Remarks on result:

other: Individual scores not available from report

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

from all animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

110

Remarks on result:

other: Individual scores not available from report

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test material is considered to be non-irritating to the eyes of rabbits.

Executive summary:

Primary eye irritation was performed to assess the irritating potential of test substance 2-ethylhexyl 3,5,5-trimethylhexanoate. Six healthy young adult albino rabbits exhibiting no ocular defects or corneal defects were selected for testing. One-tenth of a milliliter of the test material was placed on the everted lower lid of one eye of each rabbit. The upper and lower lids were gently held together for one second before releasing, to prevent loss of the test material. 2-ethylhexyl 3,5,5-trimethylhexanoate was found to cause a Maximum Mean Total Score of 0.0. at 24, 48 and 72 hours after application, and thus is considered non-irritant to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

The primary skin irritation potential of the test article was investigated in 6 rabbits. Two 2.5 cm² square patches were placed under over intact skin and abraded skin on each rabbit. Five-tenths of a millilitre or 0.5 g of the test material was placed under each patch. The scoring of skin reactions was performed at 24 and 72 hours after removal of the collars. All test sites were wiped with a cloth to prevent further exposure.

Under the conditions of this experiment, the test material was found to cause a primary irritation score of 0.33 erythema after 24 hr administration in both healthy intact and abraded skin. All effects were reversible within 72 hours. Thus the substance is considered to be non-irritant to skin.

Eye irritation/damage

Primary eye irritation was performed to assess the irritating potential of test substance in 6 rabbits. One-tenth of a millilitre of the test material was placed on the reverted lower lid of one eye of each rabbit. The upper and lower lids were gently held together for one second before releasing, to prevent loss of the test material. The test article was found to cause a Maximum Mean Total Score of 0.0 at 24, 48 and 72 hours after application.

Thus the substance is considered to be non-irritant to eyes.

Respiratory irritation

No data are available and due to the low vapour pressure of the substance respiratory irritation is also not expected.

Human information: No human information is available regards irritation/corrosion.

Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study well documented performed prior to GLP.

Justification for selection of eye irritation endpoint:
OECD guideline study well documented performed prior to GLP.

Justification for classification or non-classification

The substance is not considered to be irritant to skin and eyes as it has been tested in vivo and showed virtually no effects to skin and no effects to eyes. Thus, it can be concluded that the test substance does not require classification for skin or eye irritation /corrosion according to CLP (Regulation EC No 1272/2008). Data on Respiratory irritation are not available but due to the low vapour pressure (0.094 Pa at 25 °C) and absence of inhalative exposure (the substance is used in skin care products) respiratory irritation is not of concern.