Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 17 August 1995; Experiment end date - 27 September 1995; Study completion date - 19 October 1995.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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 in the animal room transiently exceeded the targeted range of 40-70 %.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

yes

Remarks:

The relative humidity in the animal room transiently exceeded the targeted range of 40-70 %.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

EC Number:

264-129-6

EC Name:

Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

Cas Number:

63405-85-6

Molecular formula:

C20H18N4O5S.Na

IUPAC Name:

sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Identification: TECTILON GELB 4R ROH, FEUCHT LABORGETROCKNET (FAT 20004/I) [crude, lab dried)
Description: Red orange powder
Batch Number: P3+4 PM
Purity/Formulation: ca 90 %
Stability of Test Article: Stable under storage condition; expiration date: Sep 1998
Storage Conditions: In the original container at room temperature from direct sunlight.

Test animals

Species:

rat

Strain:

Wistar

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: females 9-10 weeks, Males 7-8 weeks
- Housing:Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch nos. 86/95 and 65/95 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst)
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 23 °C
- Humidity (%): 47 - 76 %
- 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 (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Bi-distilled

Details on oral exposure:

DOSE FORMULATION
The test article was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke & Kunkel, D-79219 Staufen).
Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke & Kunkel, D-79219 Staufen).
The preparation was made shortly before dosing.


TREATMENT
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 16 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.

Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article

Doses:

100 mg/kg (Group 1)
1000 mg/kg (Group 2)
2000 mg/kg (Group 3)

No. of animals per sex per dose:

5 males- 5 female per group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality.

Statistics:

The LOGIT-Model (COX, Analysis of Binary Data, London 1977) was used to calculate the mean lethal dose. The 90 %, 95 % and 99 % confidence limits for the toxicity value and the slope of the dose response line were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

428.55 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the end of the study period.

Clinical signs:

No clinical signs of toxicity were observed during the observation period in all animals of all groups. Except of one animal of group 2 (no. 20) which showed sedation, hunched posture, dyspnea and ruffled fur.

Body weight:

The body weight of the animals was within the normal range for rats of this strain and age for all surviving animals.

Gross pathology:

In the male and female animals of group 1 no macroscopic findings were observed. In the male and female animals of group 2 the thoracic cavity contained watery fluid and in the jejunum, black-brown contents (males) were observed. In the male and female animals of group 3 the thoracic cavity contained watery fluid (males); distended stomach and black-brown contents in the jejunum were observed, the females showed dark red discoloration of the lungs.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The mean lethal dose (LOGIT-model) for the acute oral toxicity of FAT 20004/I in rats of both sexes observed for a period of 14 days is: LD50: 428.55 mg/kg

Executive summary:

The purpose of this study was to assess the acute oral toxicity of FAT 20004/I when administered by single oral gavage to rats, followed by an observation period of 14 days. The test article was administered to groups of 5 male and 5 female rats by oral gavage, at single doses of 100 mg, 1000 mg and 2000 mg/test article/kg body weight. No clinical signs of toxicity were observed during the observation period in all animals of all groups. Except of one animal of group 2 which showed sedation, hunched posture, dyspnea and ruffled fur. The body weight of the animals was within the normal range for rats of this strain and age for all surviving animals. In the male and female animals of group 1 no macroscopic findings were observed. In the male and female animals of group 2 the thoracic cavity contained watery fluid and in the jejunum, black-brown contents (males) were observed. In the male and female animals of group 3 the thoracic cavity contained watery fluid (males); distended stomach and black-brown contents in the jejunum were observed, the females showed dark red discoloration of the lungs. Based on these observations, the mean lethal dose (LOGIT-model) for the acute oral toxicity of FAT 20004/I in rats of both sexes observed for a period of 14 days is: LD50: 428.55 mg/kg

For Males: 367.63 mg/kg

For Females: 469.40 mg/kg