4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile

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other: GLP compliant guideline study, available as unpublished report, no restriction, fully adequate for assesment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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 Nousan No. 8147

GLP compliance:

yes (incl. QA statement)

Remarks:

BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile

EC Number:

259-766-1

EC Name:

4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile

Cas Number:

55699-10-0

Molecular formula:

C14H19NO

IUPAC Name:

2-(4-tert-butyl-3-hydroxy-2,6-dimethylphenyl)acetonitrile

Details on test material:

- Name of the test substance used in the study report: 4-tert-Butyl-3-hydroxy-2,6-xylylacetonitrile

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: 6 -7 months
- Weight at study initiation: 3.91 - 4.32 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area 3000 cm2; wooden gnawing blocks (Typ KNH E-041) as enrichment from Abedd Lab. and Vet. Service GmbH Vienna, Austria
- Diet: 130 g/day, Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst BASEL, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned
- 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 of the same animal

Amount / concentration applied:

The solid test substance was minimally moistened with a suitable amount of doubly distilled water to guarantee skin contact immediately before test-substance application. Because of the natural moisture of the skin doubly distilled water was used for moistening, so that the test was carried out under conditions as physiological as possible. The test patch (2.5 cm x 2.5 cm) was covered with an amount of minimally moistened solid preparation corresponding to a dose of 0.5 g of undiluted test substance.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, flank
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed with Lutrol and Lutrol/water (1 : 1).
- Time after start of exposure: 4 h

SCORING:
Immediately after removal of the patch and approx. 1, 24, 48 and 72 h after removal of the patch. Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany) were used for reading

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Moderate erythema, observed in all animals immediately after removal of the patch. Decreased to slight erythema was still observed in all animals up to 1 hour after removal of the patch. The cutaneous reactions were reversible in all animals within 24 hours after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the conditions of the test the substance is considered to be not corrosive or irritating to the skin.

Executive summary:

The potential to cause acute dermal irritation or corrosion was assessed in a OECD 404 guideline study (compiant with GLP), by a single topical application of an amount of 0.5 g of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm covered with semiocclusive dressing. After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 1, 24, 48, and 72 hours after removal. Slight or moderate erythema was observed in all animals up to 1 hour after removal of the patch. The cutaneous reactions were reversible in all animals within 24 hours after removal. The average score (24 to 72 hours) for irritation was calculated to be 0 for erythema and for edema. It was concluded that the test substance was not irritating to the skin.