2-hydroxy-3-(prop-2-enoyloxy)propyl 2-methyl-2-propylhexanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 14, 2001 to May 18, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Molecular formula:

C16H28O5

IUPAC Name:

Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Constituent 2

Reference substance name:

Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Molecular formula:

C17H30O5

IUPAC Name:

Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate

Constituent 3

Reference substance name:

glycerol 1,3-dineodecanoate

Molecular formula:

C23H44O5

IUPAC Name:

glycerol 1,3-dineodecanoate

Constituent 4

Reference substance name:

Sum of other constituents, each of them at <1%

Molecular formula:

Not available

IUPAC Name:

Sum of other constituents, each of them at <1%

Test material form:

liquid

Specific details on test material used for the study:

Batch no.: F016143 05
Appearance: Light-yellow, clear viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

females

Details on test animals or test system and environmental conditions:

Source: Charles River Wiga, D-97633
Acclimatization: 5 days
Body weight: 2.0-2.4 kg
Temperature: ca. 20.3°C, relative humidity : ca. 58.8% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin 2123, ad libitum
Water: tap water for human consumption, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

- Hair was clipped on the dorsal areas of the trunks one day before the application of the test substance. The test sites were median on the dorsal thoracal region. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing.
- The skins were examinated for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examinated (using a cold light source KL 1500 electronic) for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily.
- Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

other: no effects were seen

Remarks:

no effects were seen

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

other: no effects were seen

Remarks:

no effects were seen

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

other: no effects were seen

Remarks:

no effects were seen

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

other: no effects were seen

Remarks:

no effects were seen

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

other: no effects were seen

Remarks:

no effects were seen

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Reversibility:

other: no effects were seen

Remarks:

no effects were seen

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema were observed. The primary irritation index was 0.0. The test substance was considered not irritating to the skin.

Other effects:

No general toxic effects of the test substance were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

does not need to be classified

Conclusions:

Under the study conditions, the test substance was considered not irritating to rabbit skin.

Executive summary:

An in vivo study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404, EU Method B.4 and EPA-Guideline OPPTS 870.2500, in compliance with GLP. Hair of 3 female rabbits (New-Zealand White) was clipped on the dorsal areas of the trunks one day before the application of the test substance. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing. The skins were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily. Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12. No general toxic effects of the test substance were observed. All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema was observed. The primary irritation index was 0.0. Under the study conditions, the test substance was considered not irritating to the skin (Wolf, 2001).