N,N-bis(2-hydroxypropyl)benzamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 2nd to May 16th, 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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 at about 20 °C
- Stability: Stable under storage conditions

Test animals

Species:

rat

Strain:

other: HanCrl: Wist Han (Glx. BRL)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 9 weeks for males, 11 weeks for females
- Housing: 5 per sex in Makrolon type-4 cages with standard softwood bedding during acclimation. Individually in makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet (e.g. ad libitum): Pelleted stabdard Kliba 3433, batch no. 07/00 rat 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): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

bi-distilled

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of the total body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/Kg bw
- Concentration (if solution): 0,5 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were examined 4 times during test (Day 1), once daily during observation period (Day 2-15). Weighing on Day 1 prior to administration, then on Day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study

Clinical signs:

other: Slight focal erythema was noted in animal no: 3,5,6,8 and 10 at the second observation day and was considered to be a test item-related non toxic effect. Slight scale skin was noted in female no. 6 at the third obsrvation day and was considered to be inc

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: EU CLP criteria not met

Conclusions:

The median lethanl dose of the substance after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50(rat): > 2000 mg/kg bw

Executive summary:

A group of five male and five female HanCrl: Wist Han (Glx. BRL)BR rats was treated with substance at 2000 mg/kg bw by dermal application. The test item was diluted in vehicle (bi-distilled water) at a concentration of 0,5 g/mL and administered at a volume of 4 mL/Kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15. Mortality/viability was recorded together with clinical signs at the same time intervals during day 1. During test days 2 -15 it was recorded two times a day. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. Slight focal erythema was noted in animal no: 3,5,6,8 and 10 at the second observation day and was considered to be a test item-related non toxic effect. Slight scale skin was noted in female no. 6 at the third obsrvation day and was considered to be incidental. All other animals were without findings. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Therefore, LD50 of the substance was determined to be greater than 2000 mg/Kg bw.