Dodecanoic acid, 3-[[3-[[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methyl]-3,5,5-trimethylcyclohexyl]imino]-2,2-dimethylpropyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

supporting study

Study period:

2004-11-03 to 2004-11-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read across to hydrolysis product.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 92/69/EEC

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

102985-93-3

Cas Number:

102985-93-3

IUPAC Name:

102985-93-3

Constituent 2

Reference substance name:

2,2-Dimethyl-3-lauroyloxy-propanal

IUPAC Name:

2,2-Dimethyl-3-lauroyloxy-propanal

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: young adult rabbits 10 weeks old
- Weight at study initiation: 2513-2764 g
- Housing: Animals were housed individually in metal cages.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5mL
- Concentration (if solution): 100 %

Duration of treatment / exposure:

4 hours

Observation period:

Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours after the patch removal.

Number of animals:

3 male animals

Details on study design:

TEST SITE
- Area of exposure: 6 %.
- Type of wrap if used: plastic.

REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test item was removed with water at body temperature.
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
- The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No response observed.

Other effects:

None.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test item 2,2-Dimethyl-3-lauroyloxy-propanal applied to the rabbits’ skin evoked no observable irritating response. Thus, the classification of the test item as a skin irritant is not required.

Executive summary:

The acute skin irritation study of 2,2-Dimethyl-3-lauroyloxy-propanal was performed in New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). The test item was administered in a pure state, as a single dose of 0.5 mL, to the shaved skin of all experimental rabbits. The untreated skin of each animal served as control. After 4 hours any remaining test item was removed with water at body temperature. The animals were examined at 1, 24, 48 and 72 hours after the patch removal. No irritation symptoms (erythema and oedema) or other signs occurred after the patch removal and during the 72-hour observation period, so the study was terminated at the 72nd hour. During the study the behaviour and general state of animals were normal. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00 respectively. Thus, the classification of the test item 2,2-Dimethyl-3-lauroyloxy-propanal as a skin irritant is not required.