N,N'-(2-chloro-1,4-phenylene)bis(3-oxobutaneamide)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-12-20 to 2000-02-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

updated Guideline, adopted: February 24, 1987

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-010-4

EC Name:

-

Cas Number:

53641-10-4

Molecular formula:

C14H15ClN2O4

IUPAC Name:

N-[3-chloro-4-(3-oxobutanamido)phenyl]-3-oxobutanamide

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

HSD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstraße 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 weeks
- Weight at study initiation: males: 216 - 241 g, females: 203 - 227 g
- Randomization: Randomization schemes 98.0397 and 98.0698
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate, one animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least seven days
- Animal identification: cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

deionized

Details on dermal exposure:

Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm2.
The appropriate amount of the test substance was moistened on a two-ply gauze and an aluminium foil (6 x 8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal’s body.
At the end of the dermal exposure period of 24 hours the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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: Body weight on test days 1 (pre-administration), 8 and 15. Clinical signs: Each animal was examined for changes in appearance and behaviour twice every day , on weekends and on public holidays once per day.
At the end of the observation period the animals were sacrificed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

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:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other:

Gross pathology:

The animals killed at the end of the observation period
showed no macroscopically visible changes.

Other findings:

The skin of the animals showed no signs of irritation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU-REACh

Conclusions:

No deaths occurred during the whole study. Based on the results obtained in this study the LD50 of the test item is greater than 2000 mg/kg bw for male and female rats.

Executive summary:

No deaths occurred during the whole study. The development of body weight was not impaired, with except for one female animal, which showed an increase in body weight gain from day one to day eight of the study. From day eight up to the end of the study the body weight turned to normal. No symptoms were observed after administration of 2000 mg/kg bw. The skin of the animals showed no signs of irritation. At the end of the observation period the animals showed no macroscopically visible changes in gross pathology.