Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb - Mar 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline conform GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate

EC Number:

228-726-5

EC Name:

Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate

Cas Number:

6337-43-5

Molecular formula:

C22H26O8

IUPAC Name:

1,3-diethyl 2-({4-[3-ethoxy-2-(ethoxycarbonyl)-3-oxoprop-1-en-1-yl]phenyl}methylidene)propanedioate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (male), 10 weeks (females)
- Body weight: 2.0 -2.1 kg
- Housing: individually, in stainless steel cages
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimatization: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 5. Feb. To: 14. Feb. 2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1 hour post application
24 hours post application
48 hours post application
72 hours post application

Number of animals:

3

Details on study design:

Four days before treatment, one flank was clipped with an electric clipper, exposing an area of approx. 100 cm2 (10 x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was agein clipped.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.5 g of the test item was placed on a surgical gauze patch (ca. 4 x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of the treatment was 4 h. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no erythema in any animal at any observation time

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no edema in any animal at any observation time

Irritant / corrosive response data:

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all score 0). The individual mean score for erythema/eschar and edema of the three animals was therefore 0.
No irreversible alterations of the treated skin were observed nor corrosive effects evident on the skin.

Other effects:

No signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based upon the classification criteria (EU Classification Labelling and Packaging Regulation (1272/2008/EC)), the substance is considered to be not irritating.

Executive summary:

The substance was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404.

With reference the reported scores (edema (mean):0, erythema (mean): 0) The substance does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).