Octadecanoic acid, 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Expiration date of the lot/batch: None provided
- Receipt date: February 7, 2000
- Appearance: White to offwhite granules
- storage: stored at room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS New Zealand White rabbits
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: adult
- Weight at study initiation: not mentioned
- Housing: housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 33-35
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 6.-10.3.2000

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g, 100%

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: /
- Type of wrap if used: elastic wrap was then further secured with adhesive tape around the trunk at the cranial and caudal ends

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze moistened with deionized water followed by dry gauze.
- Time after start of exposure: 4h

Dermal Observations
Animals were examined for signs of erythema and edema and the responses scored 1 hour after patch removal and at approximately 24, 48 and 72 hours after patch application according to the Macroscopic Dermal Grading System which is based on Draize.

Clinical Observations
Any unusual observations and/or mortality were recorded. General health/mortality checks were performed twice daily (in the morning and in the
afternoon).

Body Weights
Individual body weights were obtained for each animal priorto dosing on day 0 and prior to euthanasia.

Gross Necropsy
Each animal was euthanized by an intravenous injection of sodium pentobarbital following its final scoring interval. Gross necropsy examinations were not required for these animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Table 1: Mean Irritation Scores in Individual Animals

Animal No.	Erythema	Edema
R2101/M R2102/M R2103/M	0.33 0.00 0.33	0.00 0.00 0.00
Irritation Rating	Nonirritant	Nonirritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The potential irritant and/or corrosive effects of the test substance were evaluated on the skin of New Zealand White rabbits. Each of three rabbits received a 0.50 g dose of the test article as a single dermal application. The test article was moistened with deionized water to enhance test article contact with the skin. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with deionized water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 72 hours following patch application. Exposure to the test article produced very slight erythema on 3/3 test sites at the 1 -hour scoring interval. The dermal irritation resolved completely on all test sites by the 48-hour scoring interval.