[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Guideline followed

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium

EC Number:

271-352-2

EC Name:

[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium

Cas Number:

68541-72-0

Molecular formula:

C20H13CrN4O5S

IUPAC Name:

[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 175 to 204 g
- Housing: Macrolon cages type 4
- Diet: ad libitum ((NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)
- Water: ad libitum
- Acclimation period: at least 5 days
- Fasting- overnight before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

None

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

None

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 to 4 days.

Gross pathology:

At necropsy, no deviations from normal morphology were found in all animals.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of compound FAT 20042/D in rats is >2000 mg/kg bw.

Executive summary:

FAT 20042/D was investigated for acute oral toxicity in a study conducted according to OECD Guideline 401. In this study, group of rats (5 males and 5 females) were administered the test substance at 2000 mg/kg bw and observations for mortality, clinical signs, body weights were done for 14 days post administration. No mortalities occurred in this study. Piloerection , hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 to 4 days. Body weight and body weight gain were not affected. At necropsy, no deviations from normal morphology were found in all animals. Based on the findings, the acute oral median lethal dose (LD50) of compound FAT 20042/D in rats was found to be >2000 mg/kg bw in both sexes.