9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 November 1982 to 16 November 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)

EC Number:

264-092-6

EC Name:

9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)

Cas Number:

63310-16-7

Molecular formula:

C21H39O5B (based on the representative structure below)

IUPAC Name:

2-hydroxy-3-{[hydroxy({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}propyl (9Z)-octadec-9-enoate; 3-{[bis({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}-2-hydroxypropyl (9Z)-octadec-9-enoate; {2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy}boronic acid

Test material form:

liquid: viscous

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nitabell Rabbitry, Hayward, California, USA
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 2.21 - 2.44 kg (males); 2.09 - 2.46 kg (females)
- Housing: individually in wire-bottom cages
- Diet: approximately 115 g Purina Rabbit Chow #5321, daily
- Water: ad libitum
- Acclimation period: 5 - 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 ºC
- Humidity (%): 55 - 77 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 9 November 1982 to 16 November 1982

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL test material was applied to each of two intact and two abraded sites, on the back of each rabbit.

Duration of treatment / exposure:

4 hours

Observation period:

7 days post administration

Number of animals:

6 rabbits were used for the study

Details on study design:

TEST SITE
- Area of exposure: the backs were clipped free of fur the day before dosing. The epidermal abrasions (cross hatching) were made with a hypodermic needle penetrating the stratum corneum over areas of one square inch.
- Type of wrap if used: the treated area was covered with a gauze patch which was secured by adhesive tape. The trunk of each animal was loosely wrapped in a plastic sheet and paper towels were wrapped around the plastic sheets to prevent tearing. A collar was placed on each animal to protect the wrappings during the exposure period.

REMOVAL OF TEST SUBSTANCE
- After the 4 hour exposure period, the wrappings were removed and the skin wiped to remove any remaining test material.

SCORING SYSTEM: irritation was scored at 1, 24, 48 and 72 hours and at 7 days, using the scoring method of Draize (see "Any other information on materials and methods incl. tables" for more information).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

0

Max. score:

8

Remarks on result:

other: No signs of irritation observed

Irritant / corrosive response data:

The test material caused no irritation but did stain the skin of all animals yellow. The primary irritation score was 0.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The skin irritation potential of the test material was determined following a method equivalent to that in standardised guidelines OECD 404 and EU Method B.4. During the study, six rabbits received four hour applications of 0.5 mL test material to two intact and two abraded sites. All animals were assessed for the following 7 days for any signs of skin irritation. Under the conditions of the study, the test material caused no irritation, either to intact or abraded sites, but did stain the skin of all animals yellow. The primary irritation score was 0. The test material was subsequently concluded to be not irritating to the skin.