Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

According to OECD and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

EC Number:

225-935-3

EC Name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

Cas Number:

5160-02-1

Molecular formula:

C17H13ClN2O4S.1/2Ba

IUPAC Name:

barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, SPF breeding colony
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: male 178 g - 183 g (mean 181 g), female 177 g - 186 g (mean 182 g) on day 1 (treatment)
- Fasting period before study: from 16 hours before to 3 - 4 hours after treatment, access to water permitted
- Housing: in groups of five in Makrolon type 4 cages with standard softwood bedding
- Diet: standard rat diet (Altromin 1324) ad libitum
- Water: tap water in plastic bottles ad libitum
- Acclimation period: not necessary (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Amount of vehicle (if gavage): 10 mL/kg body weight (test item in vehicle administered)
- Purity: Oleum Sesami Ph. Eur. III, Mainland Pharmazeutische Fabrik GmbH, Frankfurt

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days starting with treatment day 1
- Frequency of observations and weighing:
- mortality/viability: during the first 30 minutes and approximately 1, 2, 4 and 6 h after administration on day 1 and twice daily (weekends and public holidays once daily) on days 2-15
- clinical signs: during the first 30 minutes and approximately 1, 2, 3 and 6 h after administration on day 1 and twice daily (weekends and public
holidays once daily) on days 2-15
- body weights: on days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

None

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured during the whole study

Clinical signs:

other: the animals showed sunken flanks, stilted gait and squatting posture. All clinical signs of intoxication were reversible one day after application. Red coloured feces were observed one day after application

Gross pathology:

No macroscopic findings at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single application of 2000 mg/kg bw of the test substance did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Executive summary:

One group of five male HoeWISK (SPF71) rats and one group of five female HoeWISK (SPF71) rats were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (sesame oil) at a concentration of 20 % (w/v) 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 30 minutes, 1, 2, 4 and 6 hours after treatment on day 1 and twice daily (weekends and public holidays once daily) during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 4 and 6 hours after administration on test day 1 (with the clinical signs) and twice daily (weekends and public holidays once daily) during days 2-15. 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.

The animlas showed sunken flanks, stilted gait and squatting posture. All clinical signs of intoxication were reversible within one day after applikation

Development of body weight was not impaired.

No macroscopic findings were recorded for the animals at scheduled necropsy.

Therefore, the test substance has not to be classified as acutely toxic or as STOT SE according to Regulation (EC) No 1272/2008.