N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Sep - 03 Oct 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide

EC Number:

287-466-0

EC Name:

N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide

Cas Number:

85508-41-4

Molecular formula:

C21H21ClN6O6

IUPAC Name:

N-{2-[(2-chloro-4,6-dinitrophenyl)diazenyl]-5-(diallylamino)-4-methoxyphenyl}acetamide

Test material form:

solid: particulate/powder

Details on test material:

- Name in test report: Disperse Blue 291.1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 188.3 g +/- 10.8 g
- Housing: in transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70% r.h.
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw (single dose)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The acute oral toxicity of Disperse Blue 291.1 was tested only at a dose level of 2000 mg/kg body weight (limit test) according to toxicity data of related compounds. The animals received the compound as a 20 % suspension in tylose, the administration volume
was 10 mL/kg body weight. If no compound-related mortality is produced in this limit test according to the guidelines no further dose has to be tested.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice per day (once per day during weekends)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels

Key result

Sex:

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:

No mortality occured

Clinical signs:

other: 30 – 60 minutes hour after administration: uncoordinated gait, squatting posture and irregular respiration Urine was discolored red on day 1 and later on up to day 3 discolored dark as well as faeces.

Gross pathology:

No macroscopically visible changes observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance did not lead to any deaths. Only transient unspecific clinical signs of acute toxicity were seen after oral exposure (gavage) of 6 female rats. The LD50 > 2000 mg/kg bw. The substance is not classifiable according to GHS criteria.

Executive summary:

An acute oral toxicity study with Disperse Blue 291:1 was conducted in female rats according to OECD 423 at the limit dose levels of 2000 mg/kg body weight.

No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific clinical signs the animals showed impairments of motility and respiration starting 30 – 60 minutes after test substance administration. Additionally, urine was discoloured reddish on Day 1 and further on, urine and faeces were discoloured dark up to Day 3. From day 4 until the end of the study, no clinical signs were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period and underwent necropsy. No macroscopically visible changes were observed during necropsy.