Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate

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: Guideline study (OECD TG 404), with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate

EC Number:

281-339-3

EC Name:

Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate

Cas Number:

83929-47-9

Molecular formula:

C15H10Cl2N2O5

IUPAC Name:

methyl 4-[(2,5-dichlorophenyl)carbamoyl]-2-nitrobenzoate

Details on test material:

- Name of test material (as cited in study report): Nitro-MMT-Dichloranilid-25 TF8

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.8-3.5 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.1 ml 0.9% NaCl solution

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #16, 17, 51 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (erythema) at any time

Results 2

Irritation parameter:

edema score

Basis:

animal: # 16, 17, 51 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Irritant / corrosive response data:

No skin reactions were observed at any time point.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

The test material is not irritating to skin under these test conditions.

Executive summary:

The test material was tested in an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Five hundred mg of the test item were applied to the clipped dorsal skin of 3 rabbits for 4 hours under semiocclusive conditions. Thereafter the test item was washed of with luke warm water and erythema or edema formation were scored over a period of 72 hours. The test item did not induce any skin reactions (neither erythema nor edema) and was not irritating to skin under these test conditions.