Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study with short report but giving the essential details of the study; no GLP; poor substance characterisation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)

EC Number:

275-864-7

EC Name:

Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)

Cas Number:

71701-15-0

Molecular formula:

C42H44CrN9O6

IUPAC Name:

Chromate(1-), bis[2-[2-[4,5-dihydro-3-methyl-5-(oxo-kO)-1-phenyl-1H-pyrazol-4-yl]diazenyl-kN1]benzoato(2-)-kO]-, hydrogen, compd. with 2-ethyl-1-hexanamine (1:1:1)

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

animals were starved overnight before treatment

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous tragacanth (0,5%)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 %
- Amount of vehicle (if gavage): 50 mL/ kg

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: extreme dose and volume

Mortality:

one male died within 21 hours after treatment

Clinical signs:

other: shortIy after doSsing: lethargy, piloerection and diarrhoea.

Gross pathology:

no adverse effects

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

fhe acute median lethal oral dose (LDso) to rats of the test item was fourd to be: greater than 15 g/kg bodyweight

Executive summary:

EXPERIMENTAL PROCEDURE

Rats of the CFY strain in the weight range 142 to 174 g were starved overnight before treatment with the test item.

The test item w

as prepared as a 30% suspension in aqueous gum tragacant·h (0.5%) and administered by oral intubation at a dosage volume of 50 ml/kg bodyweight. Rats treated with the vehicle alone served as controls.

During the observation period of 14 days a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.

RESULTS

Ten rats (five males and five females) were treated with the test item at

a dosage level of 15 g/kg bodyweight.

Signs of reaction to treatment, observed shortly after dosing, consisted of lethargy, piloerection and diarrhoea. One male rat died witlln 21 hours of treatment.

Autopsy did not reveal any specific cause of death.

Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within two days of treatment. This observation was substantiated by normal bodyweight gains, compared with controls and normal autopsy findings.

CONCLUSION

The acute median lethal oral dose (LD50) to rats of he test item

was found to be: greater than 15 g/kg bodyweight.