N,N-bis(2-hydroxypropyl)benzamide

Endpoint summary

Description of key information

In two limit test studies via oral and dermal routes, according to international OECD guidelines: LD50 > 2000 mg/Kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

In two limit test studies via oral and dermal routes, according to international OECD guidelines: LD50 > 2000 mg/Kg bw.

Therefore, according to EU CLP criteria the substance should not be classified for acute toxicity via oral or dermal route.

No data are available for acute inhalation toxicity and a specific study was not performed.