N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: data sharing dispute

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

as published under Directive 84/449/EWG

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

EC Number:

258-110-1

EC Name:

N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Cas Number:

52697-38-8

Molecular formula:

C18H19BrN6O5

IUPAC Name:

N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain Bor: WISW (SPF Cpb)
- Source: WINKELMANN, Borchen
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Mean weight - Males; 170g (189-199g), Females; 170g (169-190g)
- Fasting period before study: from about 16 hours before
- Housing: in fully air-conditioned rooms in macrolon cages (type 3) on soft wood granulate in groups
of 5 animals
- Diet (e.g. ad libitum): Altromin® 1324 Pellets), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (± 2°C)
- Humidity (%): 50 (± 10 %)
- Photoperiod (hrs dark / hrs light): 12 hours daily

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning
and in the afternoon), on weekends and public holidays only once. During this time the animals were
weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: Development of body weight was not impaired.

Gross pathology:

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

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of the substance for
the male and female rat is greater than 5000 mg/kg body weight.

Executive summary:

Acute oral toxicity testing of Disperse Violet 93:1 in the rat yielded a median lethal dose (LD50) above
5000 mg/kg body weight in both male and female animals. No lethality occurred after application of 5000
mg/kg body weight. Development of body weight was not impaired. The animals killed at the end of the
observation period showed no macroscopically visible changes. Based on the results obtained in this
study the median lethal dose value (LD50) of the substance for the male and female rat is greater than
5000 mg/kg body weight.