Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

1 (reliable without restriction)

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)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

EC Number:

289-530-3

EC Name:

Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Cas Number:

89899-25-2

Molecular formula:

C20H10CrN2O8S2.Na

IUPAC Name:

Sodium [3-(hydroxy-​κO)-4-{[1-(hydroxy-​κO)-5-sulfonaphthalen-2-yl]diazenyl-​κN1}naphthalene-1-sulfonato(4-)]chromate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

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
- Diet: Rat food, NAFAG No. 890, NAFAG AG,Gossau, SG (Switzerland); ad libitum
- Water: ad libitum
- Housing: Animals were caged in groups of 5 in Macrolon cages type 3 with standardized soft wood bedding
- Fasting: Prior to dosing, the animals were fasted overnight.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity: 55±15%
- Air changes: Approximately 15 air changes per hour
- Photoperiod: Light cycle of 12 hours light and 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

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

Details on oral exposure:

Volume (ml/kg body weight) applied: 20

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: body weight, clinical symptoms

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

Preliminary study:

A preliminary study was not conducted.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured.

Clinical signs:

other: Clinical signs such as dyspnoea, exophthalamos, ruffled fir, diarrhoea and curved body position were observed during the study.

Gross pathology:

No compound related gross organ changes were observed.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of FAT 20290/A after single oral administration to male/female rats, observed over a period of 14 days is >5000 mg/kg bw.

Executive summary:

The acute oral toxicity potential of FAT 20290/A was evaluated in a study conducted according to OECD Guideline 401. Ten Tif:RAIf (SPF) rats that included 5 males and 5 females, were treated with FAT 20290/A by oral gavage administration at a dosage of 5000 mg/kg bw. The animals were examined daily during the observation period and mortality and clinical signs were recorded. Body weights were recorded on day 1 (prior to administration) and on days 7 and 14. All animals were necropsied at the end of the observation period. All animals survived until the end of the study period. Clinical signs such as dyspnea, exophthalmos, ruffled fir, diarrhea and curved body position were observed during the study. Dyspnea and exophthalmos were noted till Day 13, ruffled fur was noted till day 8. The body weight of the animals was within the range commonly recorded for this strain and age. No compound related gross organ changes were observed. Based on these findings, the median lethal dose of FAT 20290/A after single oral administration to rats observed over a period of 14 days is >5000 mg/kg bw.