4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

402-130-7

EC Name:

-

Cas Number:

106246-33-7

Molecular formula:

C21 H28 Cl2 N2

IUPAC Name:

4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline

Details on test material:

- Substance code: P5367
- Batch No.: 1/86
- Appearance: Off-white to yellowish powder
- Storage: At ambient temperature in the dark

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age: 6 - 8 weeks
- Weight at study initiation: 215 - 305 g
- Housing: groups of 5 by sex in suspended polypropylene cages
- Diet: Special Diet Services Expanded Rat and Mouse Maintenance Diet No. 1
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23°C
- Humidity: mean 51%

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The test material, at a dose level of 2000 mg/kg, was applied evenly onto the prepared gauze dressing and wetted with distilled water. The dressing was then applied to the shaved back of each rat with approximately 10% of the body surface in contact with the test material. The trunk of the rat was then encircled with a strip of non-irritating tape (Sleek).

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Each rat was individually housed for a contact period of 24 hours following application, after which the dressing was removed and the skin wiped with a damp tissue to remove excess material. The rats were then returned to their original cages. The rats were observed frequently on the day of dosing and for 14 days following dosing. They were weighed immediately prior to dosing, 7 days after dosing and at death or sacrifice at the end of the 14 day
observation period. At death or at the end of the observation period and sacrifice by nitrogen asphyxiation, each animal was subjected to a gross post mortem.
- ;

Results and discussion

Preliminary study:

no pre-test performed

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

MALES:
- 2000 mg/kg bw: No mortality observed in males.


FEMALES:
- 2000 mg/kg bw: No mortality observed in females

Clinical signs:

other: No deaths and no clincal signs of toxicity observed.

Gross pathology:

No effects on organs observed.

Other findings:

No signs of local toxicity observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 on Sprague-Dawley rats (both sexes) was found to be > 2000 mg/kg.

Executive summary:

The study was performed 1986 as GLP-test following EU-testing method B.3. The used species were Sprague-Dawley rats; 5 males and 5 females were treated with a single dose of 2000 mg/kg. The test item was moistened with distilled water and applied by occlusive dressing. Neither clinical signs nor effects on organs were noted. Body weight gains were lower than expected, particularly in females.

In conclusion, the acute dermal LD50 was determined to be > 2000 mg/kg.