Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes

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, no GLP, short report, no analytical data

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)

GLP compliance:

no

Remarks:

pre.dates GLP-regulations

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes

EC Number:

276-160-2

EC Name:

Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes

Cas Number:

71888-93-2

Molecular formula:

C63H66ClN10O12xCo

IUPAC Name:

Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Diet (e.g. ad libitum): starved overnight before treatment

no further data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: water with 0,5 % tragacanth

Details on oral exposure:

VEHICLE
- Aqueous tragacanth (0,5 %)
- Concentration in vehicle: 40 %


MAXIMUM DOSE VOLUME APPLIED: 37,5 mL/kg

Doses:

15000 mg/kg

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

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died within 66 hours after treatment.

Clinical signs:

other: Lethargy, piloerection, and diarrhoea. Orange stained urine was observed from all rats.

Gross pathology:

Normal

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The extreme limit dose of 15000 mg/kg aplied by oral gavage to rats caused death in 1 of 10 animals only. The LD50 was above 15000 mg/kg bw..

Executive summary:

METHOD:

10 rats (five males and five females) of the CFY strain, in the weight range 130 to 158 g were starved overnight before treatment with the test item.
The test item was prepared as a 40% suspension in aqueous gum tragacanth (0. 5%) and administered by oral intubation at a dosage volume of 37.5 ml/kg bodyweight. Rats treated with the vehicle alone (37.5 ml/kg) 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 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. Orange stained urine was observed from all rats.

One female rat died within 66 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. Slightly depressed bodyweight gains were observed during the first week of observation, but returned to normal during the second week of observation, compared with controls. Terminal autopsy findings were normal.

 

CONCLUSION

The acute median lethal oral dose (LD50) to rats of the test item was found to be greater than 15000 mg/kg bodyweight.