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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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

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