N,N-bis(2-hydroxypropyl)benzamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 15th to May 31st

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class 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

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 (range of 17-23 °C)
- Stability: Stable under storage conditions

Test animals

Species:

rat

Strain:

other: HanBrl: Wist (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Biotechnology and animal Breeding Division CH-4414 Fullinsdorf/Switzerland
- Age at study initiation: 8 weeks for males, 10 weeks for females.
- Housing: 3 per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- 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

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0,2 g/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test for EU CLP classification

Doses:

2000 mg/Kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Mortality/viability: daily during acclimation, twice daily during days 1-15
Body weights: on test day 1 (pre-administration), 8 and 15
Clinical signs: daily during acclimation, four times on day 1, once daily dusign days 2-15

- 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: No clinical signs were noted during the course of the study

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 oral 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 three male and three female HanBrl: Wist(SPF) rats was treated with substance at 2000 mg/kg bw by oral gavage. The test item was diluted in vehicle (bi-distilled water) at a concentration of 0,2 g/mL and administered at a volume of 10 mL/Kg. The animals were examined for clinical signs daily during acclimation, 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 acclimation, day 1 and days 2 -15. 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. No clinical signs were evident during the course of the study. 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.