Benzeneacetic acid, 2-(6-carboxy-2,3-dimethylphenoxy)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18-28 November 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to EC and OECD guidlines and according to GLP principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(carboxymethyl)phenoxy]-3,4-dimethylbenzoic acid

EC Number:

601-485-7

Cas Number:

117570-93-1

Molecular formula:

C17 H16 O5

IUPAC Name:

2-[2-(carboxymethyl)phenoxy]-3,4-dimethylbenzoic acid

Constituent 2

Reference substance name:

2-(6-carboxy-2,3-dimethylphenoxy)-benzeneacetic acid

IUPAC Name:

2-(6-carboxy-2,3-dimethylphenoxy)-benzeneacetic acid

Details on test material:

Name of test material (as cited in study report): ASA404 C7
- Substance type: off-white powder
- Physical state: solid
- Analytical purity:99.9%
- Purity test date: 18 September 2008
- Lot/batch No.: 072301
- Expiration date of the lot/batch:18 March 2009
- Stability under test conditions: not indicated
- Storage condition of test material: stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 8-16 weeks
- Weight at study initiation: 1822-2907 grams
- Housing:individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.8-23.6
- Humidity (%): 42-61
- Air changes (per hr):approximately 15
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: 18 November 2008 To: 28 November 2008

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g test substance moistened with 0.3 mL water

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2X3 cm
- % coverage: 100%
- Type of wrap if used: A metalline patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned of residual test substance using tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

0

Reversibility:

other: no irritation noted

Irritant / corrosive response data:

No erythema or oedema was caused by 4 hours exposure to ASA404 C7

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

no irritation