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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
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other: GLP-compliant guideline study, available as unpublished report, Test itm purity less than 80%., fully adequate for assessment.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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
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

Constituent 1
Chemical structure
Reference substance name:
4-({[4-(acryloyloxy)butoxy]carbonyl}oxy)benzoic acid
EC Number:
608-403-9
Cas Number:
297132-04-8
Molecular formula:
C15H16O7
IUPAC Name:
4-({[4-(acryloyloxy)butoxy]carbonyl}oxy)benzoic acid
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.

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

Resultsopen allclose all
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
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
other: mean 24-48-72 h
Score:
0
Max. score:
4
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