2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: data sharing dispute

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate

EC Number:

222-813-1

EC Name:

2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate

Cas Number:

3618-72-2

Molecular formula:

C23H25BrN6O10

IUPAC Name:

2-{[2-(acetyloxy)ethyl]({4-[ (E)-2-(2-bromo-4,6-dinitrophenyl)diazen-1-yl]-5acetamido-2-methoxyphenyl})amino}ethyl acetate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

10 ml/kg
All rats were dosed once only by gavage using a metal cannula attached to a graduated syringe. The
dose volume administered to each animal was calculated according to its fasted bodyweight at the
time of dosing.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

A group of ten fasted rats (five males and five females) were dosed at the highest dose level used in
the range finding study which caused less than 50% mortalities.
Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Mort
alities and evidence of overt toxicity were recorded at each observation. Individual bodyweights were
recorded on the day of dosing (day 0) and on days 7 and 14.
AlI animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tis
sues were retained.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 850 mL/kg bw

Based on:

act. ingr.

Mortality:

No mortality was recorded

Clinical signs:

irregular respiration

Body weight:

lower than 10% body weight loss

Remarks:

Normal bodyweight gains were recorded for all animals during the study period.

Gross pathology:

No abnormalities were seen at necropsy at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the nominal LC50 was determined to be >5000 mg/kg bw (i.e. >4870 mg
a.i./kg bw).

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance to rats according
to OECD Guideline 401. Sprague Dawley rats were administered a single dose of the test substance
(97.4% purity) in arachis oil via gavage. There were 5 male and 5 female rats per group, exposed to
a nominal concentration of 5000 mg/kg bw (equivalent to 4870 mg a.i./kg bw). The animals were then
observed during 14 days for mortality and clinical signs. Bodyweights were recorded on the day of dosing
and on Days 7 and 14. All animals were subjected to gross necropsy examination for macroscopic
abnormalities at test end. No tissues were retained. There was no mortality. Hunched posture and
piloerection were noted in alI treated animals on the day of dosing and on Day 1. All rats also showed
decreased respiratory rate and orange stained urine at the 4 h observation point. The clinical signs
resolved by Day 2. Normal bodyweight gains were recorded throughout the study and no abnormalities
were seen at necropsy. Under the study conditions, the nominal LD50 was determined to be >5000 mg/
kg bw (i.e. >4870 mg a.i./kg bw) (Archroma, 1986).