Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-09-20 to 1982-10-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1981

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)

EC Number:

308-114-5

EC Name:

Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)

Cas Number:

97862-65-2

Molecular formula:

C40H28CrN8O10S2.C28H31N2O3.C20H32N

IUPAC Name:

Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)

Test material form:

solid: particulate/powder

Details on test material:

- Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder

Specific details on test material used for the study:

- Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder

Test animals

Species:

rat

Strain:

other: Tif:RAIF (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 -8 weeks
- Weight at study initiation: 151 - 211 g
- Housing: Animals were caged in groups of 5 in Macrolon cages type 3 with standardised soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: Rat food, NAPAG No. 890, NAPAG AG Gossau, Switzerland, provided ad libitum
- Water: Drinking water, provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25, 50, 100 mg/mL vehicle
- Amount of vehicle: 10 mL

Doses:

250, 500, 1000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

From the body weights the group means and their standard deviations were calculated. Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

525 mg/kg bw

Based on:

test mat.

95% CL:

> 417 - < 688

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

525 mg/kg bw

Based on:

test mat.

95% CL:

> 345 - < 871

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

525 mg/kg bw

Based on:

test mat.

95% CL:

> 345 - < 871

Mortality:

Males
250 mg/kg bw: no mortalities
500 mg/kg bw: 2 mortalities, both 2 h after treatment
1000 mg/kg bw: 5 mortalities, one at 1h after treatment, four at 2 h after treatment.

Females
250 mg/kg bw: no mortalities
500 mg/kg bw: 2 mortalities, both 2 h after treatment
1000 mg/kg bw: 5 mortalities, one at 1h after treatment, four at 2 h after treatment.

Clinical signs:

other: No specific symptoms were seen, except for transient clonic- tonic muscle spasms in the animals treated with 500 mg/kg.

Gross pathology:

No compound related gross organ changes were observed. However, due to the colour of the test item, a red discoloration of the whole body was observed during 9 days in the animals treated with 250 mg/kg and during the whole observation period in the animals treated with 500 mg/kg.

Other findings:

The surviving animals recovered within 10 days.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria