Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

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 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

EC Number:

251-257-2

EC Name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Cas Number:

32846-21-2

Molecular formula:

C23H26N4O6S2.Na

IUPAC Name:

sodium 6-amino-5-({2-[cyclohexyl(methyl)sulfamoyl]phenyl}diazenyl)-4-hydroxynaphthalene-2-sulfonate

Test material form:

other: solid

Specific details on test material used for the study:

Code No: FAT 20003/G
Batch NO: EN 200106.49
Stability: guaranteed by the sponsor until June 1989
Description: solid
Contents of active ingredient: 80.5 %
Test Article Received: July 5, 1984

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
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 170-198 g
- Fasting period before study: Overnight fasting
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 5515%
- Air changes: 15 air changes/h
- Photoperiod: 12 h light/12 h day

IN-LIFE DATES: From: July 10, 1984 to: July 24, 1984

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days;
Signs and symptoms: daily
Body weight: on Days 1, 7, 14 and at death
- Necropsy of survivors performed: Yes; spontaneously dying animals were submitted to gross necropsy as soon as possible; survivors at the end of the observation period.

Statistics:

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

Results and discussion

Preliminary study:

not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed throughout the observation period.

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur, and curved body position were seen. In addition, a slight sedation and diarrhoea were observed shortly after the application. The animals recovered within 11 days.

Gross pathology:

No treatment-related deviations from normal morphology could be detected.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test substance was >5000 mg/kg bw.

Executive summary:

A study was conducted on FAT 20003/G to assess the acute oral toxicity of the test substance in Tif: RAIf (SPF) rats according to OECD Guideline 401.

A group of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 5000 mg/kg bw of the test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals during a 14 d observation period.

No mortality was observed throughout the observation period. Normal body weight gains were recorded in all the animals throughout the study. Dyspnoea, exophthalmos, ruffled fur, and curved body position were seen. In addition, a slight sedation and diarrhoea were observed shortly after dosing. The animals recovered within 11 days. Terminal necropsy findings were normal.

Under the study conditions, the oral LD50 of the test substance was >5000 mg/kg bw in male and female rats.