Reaction products of disodium 3,5-diamino-2-[(2-sulfonatophenyl)diazenyl]benzoate and  diazotised sodium 2-[(4-aminophenyl)sulfonyl]ethyl sulfate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 06 February 2003; Experiment completion date - 04 March 2003; Study completion date - 13 March 2003.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identity: FAT 40’810/A
Description: Brown solid
Batch number: WP 6/02
Expiry date: 12-DEC-2009
Purity: approx. 75.0%
Stability of test item dilution: For at least 7 days in water at room temperature.
Storage conditions: In the original container, at room temperature (range of 20 ±3 °C, provided at RCC Ltd), away from direct sunlight.

Specific details on test material used for the study:

Identity: FAT 40810/A
Batch: WP 6/02
Purity: approx. 75 %
Appearance: Solid, dark brownish powder
Expiration date: 12 December 2010
Storage: At room temperature at about 20 °C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system: Rat, HanBrl: Wist (SPF)
Rationale: Recognized by the international guidelines as a recommended test system.
Source: RCC Ltd, Biotechnology and Animal Breeding, CH-4414 Füllinsdorf / Switzerland
Number of animals per group 3 males and 3 females
Total number of animals 3 males and 3 females
Age when treated: Males: 8 weeks, Females: 12 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked immediately prior to treatment.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Husbandry: Room no. 104/ RCC Ltd, Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10 – 15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 ± 3 °C and for relative humidity between 30 - 70 % (values above 70 % during cleaning process possible), 12 hours fluorescent light 12 hours dark, music during the light period.
Accommodation: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 67/02 (Provimi Kliba AG, CH-4303 Kaiseraugst Switzerland) ad Iibitum. Results of analyses for contaminants are archived at RCC Ltd, ltingen.
Water: Community tap water from Füllinsdorf ad Iibitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, ltingen.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for 17 to 19 hours (access to water was permitted). Food was provided again 3 hours after dosing. The application volume was 10 ml/kg body weight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females and 3 males

Control animals:

no

Details on study design:

The study strictly followed the OECD 423 toxic class methodology and in lack of mortality and other effects at 2000 mg/kg bw no further doses were tested. Animals were observed for 15 days following dosing for mortality/viability (daily), body weight (prior to administration, on days 8 and 15) and clinical signs (daily). Following the observation period, the animals were killed by intraperitoneal injection and macroscopic examinations were performed.

Statistics:

No statistics was applied in lack of symptoms/mortality.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: No clinical signs were observed during the course of the study. No deaths occurred during the study. CLINICAL SIGNS: No clinical signs were observed in any animals. BODY WEIGHTS: The body weight of all animals was within the range commonly

Gross pathology:

Effects on organs: No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute LD50 (oral, rat) of FAT 40810/A: >2000 mg/kg bw

An acute oral toxicity study was conducted in accordance with OECD test guideline 423 and EEC B.1 to assess toxicity of FAT 40810/A upon single administration.

Executive summary:

An acute oral toxicity study was conducted in accordance with OECD test guideline 423 and EEC B.1 to assess toxicity of FAT 40810/A upon single administration. Three male and three female HanBrl: WIST (SPF) rats were treated with FAT 40810/A by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of FAT 40810/A after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight.