4'-chloro-2',5'-dimethoxyacetoacetanilide

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:

other: well performed OECD and GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4'-chloro-2',5'-dimethoxyacetoacetanilide

EC Number:

224-638-6

EC Name:

4'-chloro-2',5'-dimethoxyacetoacetanilide

Cas Number:

4433-79-8

Molecular formula:

C12H14ClNO4

IUPAC Name:

N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide

Details on test material:

- Name of test material (as cited in study report): Naphthol AS-IRG

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Origin: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 7950 Biberach
Animal identification: numbered ear tags
Weights: 2.7 - 3.2 kg
Age: about 3 - 5 months
Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
Temperature: 18 +/- 3 °C
Relative humidity: 55 +/- 20 %
Lighting time: 12 hrs per day
Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum
Water: deionized, chlorinated water from automatic water dispensers, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

0.5 g Naphtol pasted with 0.3 ml polyethylene glycol 400

Duration of treatment / exposure:

Exposure period: 4 hrs. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Observation period:

Total observation period: 72 hrs.
Observations at: 30-60 min, 24, 48 and 72 hrs after removal of patches

Number of animals:

3

Details on study design:

Type of wrap: cellulose patch
Area exposed: 2.5 x 2.5 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean of animal # 72, 176, 177 each

Time point:

other: Mean of 24, 48, 72 h

Score:

0

Reversibility:

other: initial slight effects were fully reversible wihin 24 h

Results 2

Irritation parameter:

edema score

Basis:

other: mean of animal # 72, 176, 177 each

Time point:

other: Mean of 24, 48, 72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: no effects at any time

Irritant / corrosive response data:

No signs of irritation/corrosion except very slight erythema (at 1h) have been observed during the entire study period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Not irritating

Executive summary:

The test item was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg Naphthol AS-IRG mixed with 0.3 ml polyethylene glycol 400 were applied to the shaved skin of New Zealand White rabbits. After 4 h exposure time the semiocclusive covering was removed and remaining substance was removed from the skin with warm tap water. Mean scores (mean of 24, 48, 72 h) were claculated for oedema and erythema for each rabbit.

All calculated mean scores were 0. Based on these findings the test substance is neither skin irritating nor skin corrosing in this test.