Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 October 1995 to 10 November 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The relative humidity recorded in the experimental room was outside the range specified in the protocol (37-74 %).

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

EC Number:

274-395-5

EC Name:

Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

Cas Number:

70209-97-1

Molecular formula:

C25H22ClN5O7S2.Na

IUPAC Name:

sodium 2-({2-amino-8-hydroxy-6-[(2-methylphenyl)sulfamoyl]-1-naphthyl}diazenyl)-5-[(chloroacetyl)amino]benzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 20075/B
- Physical state: Red Powder
- Analytical purity: 63.88 %
- Lot/batch No.: 1.56
- Expiration date of the lot/batch: June 2000
- Storage condition of test material: In the original container in the refrigerator (8 °C) away from direct sunlight.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 1.56
- Expiration date of the lot/batch: June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container in the refrigerator (8 °C) away from direct sunlight.
- Stability under storage conditions: Stable under stated storage condition
- Stability of the test substance in the solvent/dispersant/vehicle/test medium: Unknown in bi-distilled water, therefore is excluded from the statement of compliance.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hanlbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 197.1 - 208.8 g; females: 176.0 - 189.6 g
- Fasting period before study: overnight fasting prior to application
- Housing: Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: Pelleted standard Kliba 343, Batch no. 66/95 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum
- Water: Community tap water from Füllinsdorf, available ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 37-74
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark

IN-LIFE DATES: From: 20-Oct-1995 To: 08-Jan-1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight

DOSAGE PREPARATION (if unusual): 2000 mg/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1 and daily during days 2-15 and weighing is done on test day 1 (pre-administered), 8 and 15 day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology.

Statistics:

None.

Results and discussion

Preliminary study:

No mortality observed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed during the observation period.

Gross pathology:

No organ abnormalities were observed at necropsy.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 of FAT 20075/B is greater than 2000 mg/kg body weight.

Executive summary:

Acute oral toxicity test was conducted according to OECD 401 guideline and in accordance with GLP in 1996. In this study the test substance was administered to a Wistar rats (5/sex) by oral gavage, at a single dose of 2000 mg test substance / kg body weight. There were no deaths as a result of treatment with the test article, no clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age and no organ abnormalities were observed at necropsy. Based on the study results, the mean lethal dose (LD₅₀) of FAT 20075/B after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg.