Benzenebutanoic acid, 4-[(4-methoxybenzoyl)amino]-.beta.-methyl-3-nitro-.gamma.-oxo-, methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 04 November 1996 to 04 February 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Compliant to GLP, adequate coherence between data, comments and conclusions. Observed deviations were not considered to have compromised the validity of the study. Indeed no observation was performed at 48 hours: however, even if an erythema and/or oedema score of 4 was observed at this time in 2/3 animals at the latest, the mean eythema and/or oedema score over 24, 48 and 72 hours would be in this case 1.3. This value would not lead to a classification according to Directive 67/548/EEC and CLP criteria ). The skin was shaved instead of being clipped as indicvated in OCDE 404: however only rabbits with intact skin were kept for the study. Some data are missing (expiration date of the tested batch, analytical certificate, storage conditions...).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

skin shaved instead of been clipped, no skin observation 48 hours after patch removal

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-290-2

EC Name:

-

Cas Number:

74149-72-7

Molecular formula:

C20H20N2O7

IUPAC Name:

methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate

Details on test material:

- Name of test material (as cited in study report): UD-CG 115 Nitrobenzamide (Gamma-NAP)
- Substance type: monoconstituent
- Lot/batch No.: 1/94
- Purity test date: 21/10/1996

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH - Biberach/Riss
- Age at study initiation: 38 - 41 weeks
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: stainless steel wire cages with a floor area of 3878 cm2
- Diet (e.g. ad libitum): standardized pelleted diet (SSNIFF Spezialdiäten GmbH)
- Water (e.g. ad libitum): filtered, demineralized water of drinking quality adjusted to pH 2.6 +/- 0.3 with hydrochloric acid
- Acclimation period: > 2 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+3°C ; -1°C)
- Humidity (%): 55% (min. 50%)
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From 04 November 1996 to 12 November 1996

Test system

Type of coverage:

other: occlusive on the right side and semi-occlusive on the left side

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

other: cranial sites, treated with physiological saline, served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (moistened with 0.5 mL of physiological saline)

Duration of treatment / exposure:

4 hours

Observation period:

1 week

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 3 x 3 cm square area of shaved skin
- Type of wrap if used: gauze bandage patches enclosed in a protective bandage

REMOVAL OF TEST SUBSTANCE
Not indicated.

SCORING SYSTEM:
Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: animals 1, 2 and 3

Time point:

other: 24 hours

Score:

0

Reversibility:

other: not applicable (no erythema observed during the study)

Results 2

Irritation parameter:

erythema score

Basis:

other: animals 1, 2 and 3

Time point:

other: 72 hours

Score:

0

Reversibility:

other: not applicable (no erythema observed during the study)

Results 3

Irritation parameter:

edema score

Basis:

other: animals 1, 2 and 3

Time point:

other: 24 hours

Score:

0

Reversibility:

other: not applicable (no edema observed during the study)

Results 4

Irritation parameter:

edema score

Basis:

other: animals 1, 2 and 3

Time point:

other: 72 hours

Score:

0

Reversibility:

other: not applicable (no edema observed during the study)

Irritant / corrosive response data:

Neither edema nor eythema was observed in any of the 3 animals at the sites treated with the test article.
Very slight erythema (grade 1) was observed in 1/3 rabbit, at 24 hours, at the site treated with physiological saline (under semi-occlusive dressing).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was not irritant by skin contact.

Executive summary:

The substance was not irritant by skin contact.