Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

IUPAC Name:

Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Test material form:

solid: particulate/powder

Details on test material:

- Description: Black powder
- Storage Conditions: Room temperature

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was prepared at a concentration of 50 % w/v in corn oil and administered at a volume of 10.0 mL/kg. The test material was prepared on the day of dosing.

Test animals

Species:

rat

Strain:

other: Crl:CD (SD) BR VAF plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Approximately four to six weeks of age.
- Weight at study initiation: Weight range of 100 to 123 g prior to dosing.
- Fasting period before study: Yes. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: Housed in groups of up to five rats of the same sex in metal cages with wire mesh floors.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: All the rats were acclimated to the experimental environment for a period of 6 days prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C to 25 °C
- Humidity (%): 60 % R.H
- Air changes (per hr): The rate of air exchange was maintained at approximately 15 air changes/hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to provide 12 hours artificial light in each 24-hour period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test material was prepared at a concentration of 50 % w/v in corn oil.

MAXIMUM DOSE VOLUME APPLIED:
The test material was administered at a volume of 10.0 mLkg.

Doses:

5.0 g/kg bodyweight. The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter (10 choke).

No. of animals per sex per dose:

Five males and five females.

Control animals:

no

Details on study design:

- Duration of observation period following administration: All animals were observed for 14 days after dosing. The day of dosing was designated Day 1.
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation. The nature, severity, approximate time of onset and duration of each toxic sign.
Individual bodyweights of rats were recorded on Days 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: Yes. All animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities. The macrospic appearance of all examined tissues were recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral dose of test material at 5.0 g/kg bodyweight.

Clinical signs:

other: Pilo-erection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1. Dark blue eyes and extremities were observed in all rats from Day 3 to Day 6 or 7. Abnormal body carriage (hunched posture) was also observed in al

Gross pathology:

Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria.

Conclusions:

Under the conditions of the study, the acute lethal oral dose was greater than 5 000 mg/kg bodyweight in male and female rats.

Executive summary:

The acute oral toxicity of the test material was assessed in the rat in accordance with the standardised guideline EU Method B.1 under GLP conditions.

A group of ten rats (five males and five females) was treated with test material at 5 000 mg/kg bodyweight. The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter (10 choke). All animals were observed for clinical signs and mortality for a period of 14 days after dosing. Individual bodyweight gains were also monitored. All animals were euthanised on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination.

There were no deaths following a single oral dose of test material at 5 000 mg/kg bodyweight. Pilo-erection was observed in all rats within five minutes of dosing and throughout the remainder of Day 1. Dark blue eyes and extremities were observed in all rats from Day 3 to Day 6 or 7. Abnormal body carriage (hunched posture) was also observed in all females during this period. Recovery, as judged by external appearance and behaviour, was complete by Day 9. Slightly low bodyweight gains during the first week of the study were recorded for one male and three female rats on Day 8. All other rats achieved anticipated bodyweight gains throughout the study. Terminal autopsy findings were normal.

Under the conditions of the study, the acute lethal oral dose to rats of the test material was found to be greater than 5 000 mg/kg bodyweight.