diethyl pyridine-2,4-dicarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10.09.2002 - 20.12.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study has been performed under GLP and according to OECD guidelines.

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)

Version / remarks:

, 17th July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EC Directive No 92/69/EEC, B.4 (Acute toxicity: Dermal Irritation/Corrosion), 31st July 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

MEXORYL SBU

IUPAC Name:

MEXORYL SBU

Constituent 2

Reference substance name:

diethyl pyridine-2,4-dicarboxylate

EC Number:

680-341-5

Cas Number:

41438-38-4

Molecular formula:

C11H13N04

IUPAC Name:

diethyl pyridine-2,4-dicarboxylate

Details on test material:

- Name of test material: MEXORYL SBU- The test material is the same than the one mentioned in section 7.2.1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: CEGAV, Saint Mars d'Egrenne, France.- Age at study initiation: 2 - 4 months- Weight at study initiation: 2.7 ± 0.1 kg- Housing: housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm)- Diet (e.g. ad libitum): free access to 110 pelleted diet- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 3- Humidity (%): 30 - 70%- Air changes (per hr): 12- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin served as control

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 500 mg

Duration of treatment / exposure:

4 hours

Observation period:

1 hour, 24, 48 and 72 hours after removal of the dressing.

Number of animals:

three males

Details on study design:

TEST SITE- Area of exposure: right flank- % coverage: - Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressingSCORING SYSTEM:Erythema and eschar formation:- no erythema: 0- very slight erythema (barely perceptible): 1- well-defined erythema: 2- moderate to severe erythema: 3- severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Oedema formation- no oedema: 0- very slight oedema (barely perceptible): 1- slight oedema (edges of area well-defined by definite raising): 2- moderate oedema (raised approximately 1 millimetre): 3- severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Under this experimental conditions, the test item is non-irritant when applied topically to rabbits.

Executive summary:

The potential of the test item Mexoryl SBU to induce skin irritation was evaluated in rabbits according to OECD TG 404. The study was conducted in compliance with the principles of GLP.

The test item was applied for 4 hours to three male New Zealand White rabbits. A single dose of 500 mg of the test item first ground to a fine powder was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

Except for a very slight erythema noted in 1/3 animal on day 1, no cutaneous reactions were observed during the study. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and oedema. Under our experimental conditions, the test item is non-irritant when applied topically to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the skin.