Sodium 6-amino-4-hydroxy-5-[[2-(phenylsulphonyl)phenyl]azo]naphthalene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

June from 7th to 30th, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01

IUPAC Name:

Similar substance 01

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5 to 8 weeks old
- Weight at study initiation: males 157 - 171 g; females 140 - 157 g.
- Fasting period before study: overnight fast immediately before dosing.
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet, ad libitum.
- Water: ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 42 - 57 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

TEST MATERIAL
- Preparation: the test material was freshly prepared, as required, as a suspension at the appropriate concentration in distilled water. The concentration, homogeneity and stability of the test material preparation were not determined by analysis.
- Concentration: 200 mg/ml
- Dose volume: 10 ml/kg. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1 male and 1 female for range-finding
5 males and 5 females for main test

Details on study design:

RANGE-FINDING
- Duration of observation: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
- Frequency of observations and weighing: individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes.
- Necropsy of survivors performed: no necropsies were performed.

MAIN STUDY
- Duration of observation: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Frequency of observations and weighing: individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: animals were killed by cervical dislocation and subiected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

RANGE-FINDING
No deaths occurred.

MAIN STUDY
No deaths occurred.

Clinical signs:

RANGE-FINDING
No clinical signs of toxicity were recorded.

MAIN STUDY
Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted.
Red-coloured staining of the fur was noted in all males.

Body weight:

MAIN STUDY
AII animals showed expected gain in bodyweight during the study.

Gross pathology:

MAIN STUDY
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (rat) > 2000 mg/kg bw

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guideline 401. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

There were no deaths. Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

Conclusion

LD50 (rat) > 2000 mg/kg bw