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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study well documented, following official guidelines, GLP compliant

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)

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disperse Blue 79:1

IUPAC Name:

Disperse Blue 79:1

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. Mortalities 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 subiected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was recorded

Clinical signs:

other: Hunched posture and piloerection were noted in alI treated animals on the day of dosing and on day one. All animals also showed decreased respiratory rate and orange stained urine at the 4-hour observation. All animals recovered and appeared normal on day

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information following the CLP Regulation Criteria used for interpretation of results: EU

Conclusions:

The substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.

Executive summary:

Ten rats were dosed once in a limit test following a dose range finding study, with the tested substance at 5000 mg/kg. The rats were observed at 1 and 4h and daily up to 14 days. No mortality was observed and clinical signs were normal at day 2 of the observation period. Under the experimental conditions the LD50 > 5000 mg/kg.