A mixture of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 July 1992 to 05 August 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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:

Batch No. HT 3728/TV 1
Purity: 60-70%
Physical properties: powder, dark red
Storage condition: room temperature, keep dark
Validity: May 15, 1997
Test material received: June 5, 1992

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Test animals

Species:

rat

Strain:

other: Tif: RAI f

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: 189 - 228 g
- Housing: test animals were housed in Macrolon cages type 4, with standardized soft wood bedding.
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) were provided ad libitum
- Fasting period before study: overnight
- Water: ad libitum
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

one single oral dose by gastric intubation

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

10 test animals (5 males and 5 females)

Control animals:

no

Details on study design:

Administration of the test article: one single dose, gavage by gastric intubation
Dose level: 2000 mg/kg (males and females)
Total number of test animals: 10
Vehicle: distilled water
Volume applied: 20 ml/kg body weight
Observation period: 14 days

Observations and records:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Statistics:

No data

Results and discussion

Effect levels

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: Pil'oerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 days.

Gross pathology:

At autopsy, a spotted thymus was found in 4 males, one of them was involuted additionally. In the same animal, a spotted liver was seen.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) in rats after oral administration was greater than 2000 mg/kg.

Executive summary:

A GLP-compliant acute oral toxicity study in Tif RAI f rats (5/sex) was carried out with FAT 45155/B and observed for a 14 day post-treatment observation period. The study was carried out according to OECD guideline 401. There was no mortality observed during the study. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 days. At autopsy, a spotted thymus was found in 4 males, one of them was involuted additionally. In the same animal, a spotted liver was seen. Based on the study results, the median lethal dose (LD50) in rats after oral administration was greater than 2000 mg/kg.