N,N-bis(2-hydroxypropyl)benzamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 05th to July 24th, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-hydroxypropyl)benzamide

EC Number:

436-010-0

EC Name:

N,N-bis(2-hydroxypropyl)benzamide

Cas Number:

422278-61-3

Molecular formula:

C13H19NO3

IUPAC Name:

N,N-bis(2-hydroxypropyl)benzamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): PRIMID V 40-32
- Physical state: Solid
- Analytical purity: 96%
- Lot/batch No.: HSH 0015.1
- Expiration date of the lot/batch: March 31, 2003
- Storage condition of test material: At room temperature in the range 17-23 °C
- Stability: Stable under storage conditions

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne/France
- Age at study initiation: 12-13 weeks for males, 10-11 weeks for females
- Weight at study initiation: 2.3-2.4 Kg
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclave wood and haysticks for gnawing
- Diet (e.g. ad libitum): Pelleted standard Kliba 3418, batch no. 90/01 rabbit maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

bi-distilled

Controls:

no

Amount / concentration applied:

0,5 g of substance per animal, diluted in bi-distilled water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 per test (both sexes)

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: individual mean score for erythema/eschar and oedema

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h after removal

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h after removal

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h after removal

Score:

0

Max. score:

0

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h after removal

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h after removal

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h after removal

Score:

0

Max. score:

0

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h after removal

Score:

0

Max. score:

0

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h after removal

Score:

0

Max. score:

0

Irritant / corrosive response data:

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times. The individual mean score for erythema/escar and oedema for each of the three animals was therefore 0.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin

Other effects:

No clinical signs of systemic toxicity and no mortality occured. No staining by the test item of the treated skin was observed. The body weights of alla rabbits were considered to be within the noraml range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Substance did not induce any reaction in rabbit skin. All erythema and oedema scores were 0. Therefore the substance can be considered as not irritating to skin

Executive summary:

The primary skin irritation potential of the substacne was investigated by topical semi-occlusive application of 0,5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment ws four hours. The scoring of skin reactions was performed 1,24,48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times. The individual mean score for erythema/escar and oedema for each of the three animals was therefore 0. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Therefore the substance can be considered as not irritating to skin.