[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-Hexanol, 2-ethyl-, reaction products with 1,6-diisocyanatohexane and Hexane, 1,6-diisocyanato-, homopolymer

EC Number:

939-549-4

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 1-Hexanol, 2-ethyl-, reaction products with 1,6-diisocyanatohexane and Hexane, 1,6-diisocyanato-, homopolymer

Test material form:

other: Liquid

Details on test material:

- Physical state / appearance: Liquid / clear, colorless - yellowish
- Homogeneity: The test substance was homogeneous by visual inspection.
- Stability: The stability under storage conditions over the period was guaranteed by the sponsor.
- Storage conditions: Room temperature, exclusion of oxygen (stored under nitrogen)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 5 months
- Weight at study initiation: 3.08 - 3.39 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of the same animal.

Amount / concentration applied:

The test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 mL of the undiluted liquid test substance.

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

- Clipping of the fur: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animal(s).
- Body weight determination: Just before application of the test substance and after the last reading.
- Route of application: The test substance was applied in a single dose to the intact untreated skin The test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1 : 1).
- Readings: lmmediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals up to day 14.
- Illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
- Check for dead animals or moribund: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
- Evaluation of results: For evaluation, the calculation of the mean values of erythema and edema for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 0 - 1 hour

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Erythema extending beyond the area of exposure in all 3 animals

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48

Score:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Erythema extending beyond the area of exposure in all 3 animals

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Erythema extending beyond the area of exposure in all 3 animals, in 2 animals dryness of the skin was observed

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 7 days

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: In two animals the study was discontinued because the animals were free of findings, in the 3rd animal scaling was observed.

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 14 days

Score:

0.33

Max. score:

4

Remarks on result:

other: In the 3rd animal scaling was observed

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 0-24 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours - 14 days

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Moderate erythema (grade 2), observed in all animals immediately and 1 hour after removal of the patch, increased to marked (grade 3) in all animals after 24 hours and decreased to slight or moderate (grade 1 or 2) in one or two animals after 48 and 72 hours. In one animal marked erythema persisted up to 72 hours, decreased to slight after day 7 and persisted up to study termination on day 14.
- Slight edema (grade 1) was noted in all animals immediately after removal of the patch up to 24 hours.
- Additionally erythema was extended beyond the area of exposure in all animals after 24 hours up to 72 hours. Moreover scaling and dryness of the skin was noted. The cutaneous reactions were reversible in two animals within 7 days, while in one animal slight erythema and scaling was still present up to study termination on day 14. Mean scores over 24, 48 and 72 hours for each animal were 2.3, 2.0 and 3.0 for erythema and 0.3 for edema.