2-ethylhexyl 3,5,5-trimethylhexanoate

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 3,5,5-trimethylhexanoate

EC Number:

275-073-7

EC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Cas Number:

70969-70-9

Molecular formula:

C17H34O2

IUPAC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Test animals

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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.

Applicant's summary and conclusion

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.