Phenol, ethoxylated, esters with acrylic acid

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, ethoxylated, esters with acrylic acid

EC Number:

500-133-9

EC Name:

Phenol, ethoxylated, esters with acrylic acid

Cas Number:

56641-05-5

Molecular formula:

C13H16O4 (PHEA-2) - C23H36O9 (PHEA-7)

IUPAC Name:

2-phenoxyethyl prop-2-enoate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Miramer M142, Lot. No.: 0082301
- Expiration date of the lot/batch: 30 April 2001
- Purity test date: Not specified
- Purity: >95%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark.
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: NA
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: NA

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: administred as supplied by sponsor.
- Preliminary purification step (if any):NA
- Final dilution of a dissolved solid, stock liquid or gel: NA
- Final preparation of a solid:NA

FORM AS APPLIED IN THE TEST (if different from that of starting material)
Exposure scenarios
OTHER SPECIFICS: NA

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Weight range beteen 2.8 and 3.8kg bw, Age at least 10weeks prior first treatment. Housed individually in metal cages. Standard laboratory diet, SQC Rabbit Diet and drinking water ad libitum. Temperature 17-21 C, relative humidity 30-70%. Air exchange per hour was not specified. 12 hour/12 hours Light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml was applied under 25*25mm gauze pads to each intact skin site on each animal.

Duration of treatment / exposure:

3 minutes, 60 minutes and 4 hours

Observation period:

On the day of exposure ( 3 minutres and one hour), 24, 48 and 72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 25 mm x 25 mm
- % coverage: not specified
- Type of wrap if used: Semi occlusive: Porous gauze pads and Elastoplast elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water 34-37 oC
- Time after start of exposure: three minutes, one hour and four hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) three minutes, one hour and four hours.

SCORING SYSTEM:
- Method of calculation: Primary irritation index (PII) was calculated from the erythema and oedema scores.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.2

Reversibility:

fully reversible within: 96 hours

Irritant / corrosive response data:

Well-defiend erythema with very slight-to-slight oedema was observed in two animals from approximately one hour after bandage removal following the four hours exposure. Reaction had resolved in both animals by Day 4 (96h). No dermal irritation was observed in the remaining animals throughout the study.

Other effects:

No signs of toxicity or ill health

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

The skin irritation potential of M142 was tested using semi-occlusive application for four hours in three Rabbits (one male and two females) according to OECD test guideline 404. Dermal irritation was observed in two of three animals 4 hours after application. The primary irritation index (PII) was calculated to be 1.2. Based on the present test M142 was not subject for classification as a skin irritating substance.

Executive summary:

The skin irritation potential of M142 was tested using semi-occlusive application for four hours in three Rabbits (one male and two females) according to OECD test guideline 404.

Dermal observations were made three minutes, one hour, four hours, 24, 48 and 72 hours after removal of the semi-occlusive dressing. Well-defined dermal irritation was observed in two of three animals 4 hours after application. The primary irritation index (PII) was calculated to be 1.2. Mean values of erythema and oedema were below the values triggering CLP classification. Hence, based on the present test M142 was not subject for classification as a skin irritating substance.