Benzoic acid, 4-[[[4-[(1-oxo-2-propenyl)oxy]butoxy]carbonyl]oxy]-, 2-methyl-1,4-phenylene ester

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:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Physical state: powder / grey-white
- Analytical purity: 95.8% (per weight; HPLC)
- Lot/batch No.: ZD 1151/ 31 (production: 03-Dec-1997)
- Storage condition of test material: refrigerator, protected from light.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG / Chbb: NZW (SPF)
- Age at study initiation: young adult animais
- Weight at study initiation: 4.00 and 3.98 kg for the 2 females, 3.92 kg for the male
- Housing: The animals were single-housed in fully air-conditioned rooms in Stainless steel wire mesh cages with grating, floor area: 3000 cm2; animal identification: ear tattoo. No bedding in the cages; wood shavings in the waste trays.
- Diet, ad libitum: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, (about 130 g per animal per day). The feed used in the study was assayed for chemical and microbiological contaminants. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Water, ad libitum: about 250 ml tap water per animal per day. The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of BASF Aktiengesellschaft as well as for the presence of germs by a contract laboratory. In view of the aim and duration of the study the contaminants occurring were seen as not likely to influence the results.
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Central air-conditioning guaranteed a range of 20 - 24 degrees
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 hours (6.00 am - 600 pm/ 6.00 pm - 6.00 am)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3 (1 male and 2 females)

Details on study design:

TEST SITE
- Area of exposure: At least 24 hours before the test, the fur was removed, by clipping the dorsal part of the trunk of the animals (upper third of the back or flanks.). Only animals with healthy intact skin have been used. The test patch (2.5 cm x 2.5 cm) was covered with unchanged solid test substance moistened with aqua bidest (because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible).
- Type of wrap if used: The test patch was secured in position with a semiocclusive dressing; test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Polyethylenglycol DAB (BASF Aktiengesellschaft) and Polyethylenglycol DAB/water (1:1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline no. 404 (adopted July 17, 1992) and EEC directive 92/69, L 383A, B.4 (December 29, 1992).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all treated animals

Time point:

other: 1-24-48-72 hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: no erythema was observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all treated animals

Time point:

other: 1-24-48-72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: no edema was observed

Irritant / corrosive response data:

Under the test conditions chosen and considering the described findings LC 242 does not give indication of an irritant property to the skin. The test substance is therefore considered not irritating according to the EU and to GHS

Other effects:

No other effects were observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met