2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25th June 1992 to 9th July 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

EC Number:

424-190-3

EC Name:

2,3,4,4'-tetrakis(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulfonato)benzophenone

Cas Number:

105641-66-5

Molecular formula:

C53H26N8O17S4

IUPAC Name:

2,3-bis({[5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)-6-[4-({[5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)benzoyl]phenyl 5-oxo-6-(λ⁵-diazynylidene)-5,6-dihydronaphthalene-1-sulfonate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: males appr. 7 weeks, females appr. 8 weeks
- Weight at study initiation: males: 178-184 g, females 169-190 g
- Housing: Makrolon Type 4 cages, groups of 5
- Diet: ad libitum Altromin 1324 rat diet
- Water: tap water ad libitum
- Acclimation period: appr. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension in sesame oil
- Amount applied: 10 mL/kg bw

Doses:

one limit dose of 2000 mg/kg bw was applied

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: Symptoms and lethality was monitored twice a day, weighings were undertaken weekly.
- Necropsy of survivors performed: yes, all animals were examined for macroscopically visible changes

Results and discussion

Preliminary study:

A dose-range finding study was performed with the following test concentrations: 500, 1000 and 2000 mg/kg bw (one animal/sex each). No clinical symptoms and deaths were observed in the 500 and 1000 mg/kg bw dose groups. Two hours after application of 2000 mg/kg bw the animals showed stilted gait and squatting posture. These symptoms were reversible at the first day p.a..

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Two hours after application the animals showed stilted gait and squatting posture, drawn flanks and bristling coat. These symptoms were reversible within the first day p.a..

Gross pathology:

No macroscopically visible changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item was greater than 2000 mg/kg bw after oral administration to rats.

Executive summary:

The acute oral toxicity of the test item was investigated in a group of five male and five female Wistar rats at a dosage of 2000 mg/kg bw. The animals were starved overnight prior to dosing. The test material was administered at a constant volume-dosage of 20 mL/kg, as a suspension (20 %) in sesame oil. Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy. There was no death and clinical signs of reaction to the treatment (two hours after application the animals showed stilted gait and squatting posture, drawn flanks and bristling coat) were reversible within the first day p.a... All animals achieved expected bodyweight gains and necropsy findings were unremarkable. Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg bw.