2-Naphthalenecarboxylic acid, 6-[[[4-[(1-oxo-2-propen-1-yl)oxy]butoxy]carbonyl]oxy]-

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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study, available as unpublished report, Test itm purity less than 80%., fully adequate for assessment.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 Nousan No. 8147, November 24 2000

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:

297132-04-8

EC Number:

608-403-9

Cas Number:

297132-04-8

IUPAC Name:

297132-04-8

Details on test material:

- Name of test material (as cited in study report): 4-(4-Acryloyloxy-butoxycarbonyloxy)-benzoic acid
- Degree of purity / content: 66.7 area %
- Physical state / appearance: Solid / white
- Homogeneity: The test substance was homogeneous by visual inspection.
- pH-value: of a 10% aqueous preparation: about 4
- Storage conditions: Room temperature, protected from humidity and light.

- Molecular formula (if other than submission substance): C15H16O7
- Molecular weight (if other than submission substance): 308.2
- Smiles notation (if other than submission substance): C=CC(=O)OCCCCOC(=O)Oc1ccc(cc1)C(=O)O
- Structural formula attached as image file (if other than submission substance): see Fig.

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 6 - 7 months
- Weight at study initiation: 3.76 - 3.91 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung ("GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

minimally moistened

Controls:

other: untreated skin of the animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g (ca 0.3g adjusted for purity)

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 (2 males and 1 female)

Details on study design:

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

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 h

SCORING SYSTEM: evaluation of skin reactions is performed according to the quoted guidelines.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24-48-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Moderate erythema (grade 2) was observed in all animals immediately after removal of the patch. Slight erythema (grade 1) persisted in 2 animals up to 1 hour and in 1 animal up to 24 hours after removal of the patch.
- No other cutaneous reactions were observed during the study.
- The cutaneous reactions were reversible in 2 animals within 24 hours and in 1 animal within 48 hours after removal of the patch.
- Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0 for edema.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU