2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sept - Oct 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24. Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

25. Apr. 1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide

EC Number:

404-910-2

EC Name:

2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide

Cas Number:

164578-14-7

Molecular formula:

C25H31N7O4

IUPAC Name:

N-[3-(diethylamino)propyl]-4-[(1E)-2-{2-oxo-1-[(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)carbamoyl]propyl}diazen-1-yl]benzamide

Test material form:

solid: bulk

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hoe:WISKf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
males: 8 weeks
females: 9 weeks
- Weight at study initiation:
males: 217 g (214-220 g)
females: 193 g (187-198 g)
- Housing: indiviudally in fully air-conditioned rooms in Macrolon cages type 3, on softwood granulate
- Diet (e.g. ad libitum): rat/mice diet Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES:
From: 19. Sept. To: 3 Oct. 1989

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x8 cm
- % coverage: 100
- Type of wrap if used: elastic gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 h after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): miostened with PEG 400 (1 g test item + 1 mL PEG 400)
- For solids, paste formed: yes

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: weekly
clinical signs: 30, 60 min, 2, 4, 6 h after application, thereafter daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

other: no clinical symptoms reported; applicattion sites were yellow colored

Gross pathology:

no changes observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation.The dermal LD50 was determined to be > 2000 mg / kg body weight.

Executive summary:

Under the conditions of the present study, a single dermal application of the substance to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of the test item after a single dermal administration to male and female rats, observed over a period of 14 days is:

LD50 > 2000 mg/kd bw; unclassified In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item has no obligatory labelling requirement for toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified. According to GHS (Globally Harmonized Classification System) the test item has no obligatory labelling requirement for toxicity and is not classified.