Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate

EC Number:

250-800-0

EC Name:

Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate

Cas Number:

31778-10-6

Molecular formula:

C29H25N5O5

IUPAC Name:

butyl 2-({2-hydroxy-3-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]-1-naphthyl}diazenyl)benzoate

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding colony
- Weight at study initiation: 82-86 g
- Fasting period before study: 16 h
- Diet: Standard-ALTROMIN R ( Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

10 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: no data
- Frequency of weighing: once a week

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animals died during the 14-day observation period

Mortality:

No animal died.

Clinical signs:

other: No clinical signs observable.

Other findings:

Test substance was excreted via the faeces.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Single oral application of 15 g test item/kg was not lethal to female rats. The LD 50 value for acute oral toxicity is > 15 g/kg bw in female Albino rats.

Executive summary:

10 Female Wistar rats were exposed to 15000 mg test item/kg bw once by gavage. Animals were observed for a period of 14 days. No animal died within this time and clinical signs and body weight development were normal. Therefore the LD50 value is > 15000 mg/kg bw for female Wistar rats.