Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]

Endpoint summary

Description of key information

Studies on inhalative acute toxicity of the test item were not performed.

The studies that were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat accorded to OECD guidelines 401 and 403. The test substance did not induce mortalities, abnormalities or clinical signs when applied oral. Also, single administration of the analogue substance via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 5000 mg/kg bw, LC50 is > 5.24 mg/l air.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

insufficient information to animals, enviromental conditions and test substance

GLP compliance:

no

Remarks:

priot to GLP-introduction

Test type:

standard acute method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Weight (g) at study initiation: 113 male, 109 female
- Fasting period before study: 18h
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Photoperiod (hrs dark / hrs light): 12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE (50 % PEG)
- Concentration in vehicle: 17 %
- Amount of vehicle (if gavage): 30 ml

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no mortality occurred

Mortality:

no mortality

Clinical signs:

other: no clinical signs

Gross pathology:

no findings

Other findings:

The faces were stained red throughout the study.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes

Limit test:

yes

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
- Age at study initiation: young adult
- Weight at study initiation: males 274 - 324g, females 244- 260g
- Fasting period before study: /
- Housing: groups of five
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 52-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: To: /

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical exposure chamber with continuous flow
- Exposure chamber volume: 30 l
- Method of holding animals in test chamber: a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber '0' ring
- Source and rate of air: compressed air was supplied by means of a Gast oil free compressor
- Method of conditioning air: passed through a water trap and respiratory quality filters which removed particulate material above 0.005 pm before
- System of generating particulates/aerosols: produced from the test material using a 'Wright Dust Feed' mechanism located at the top of the exposure chamber and driven by a variable speed motor. The dust feed was connected to a metered compressed air supply.
- Method of particle size determination: determined three times during the exposure period using a Cascade Impactor
- Temperature, humidity, pressure in air chamber: measured by an electronic thermometer/humidity meter (Kane-May Ltd., Welwyn Garden City, Hertfordshire, U.K.) located in a vacant port in the animals' breathing zone of the chamber and recorded every thirty minutes throughout the four-hour exposure period.

TEST ATMOSPHERE
- Brief description of analytical method used: The chamber was maintained under negative pressure. Homogeneity of the test atmosphere within the chamber was not specifically determined during this study, but, chambers of the same design have been fully validated and shown to produce evenly distributed atmospheres in the animals' breathing zone with a wide variety of test materials. (Green J.D. et al. Fundamental and Applied Toxicology 4, 768 - 777, 1984)
- Samples taken from breathing zone: no

VEHICLE
- air

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: particle size of the generated atmosphere of the test material inside the exposure chamber was determined three times during the exposure period using a Cascade Impactor. This device consisted of six impactor stages with stainless steel collection substrates (10, 6, 3.5, 1.6, 0.9 and 0.5 pm cut-off points) and a back up glass fibre filter. collection substrates were weighed before and after sampling and the weight of test material, collected at each stage, calculated by difference. From the results obtained the weight distribution of particles in the size range > 10 pm, 10 - 6 pm, 6 - 3.5 pm, 3.5 -1.6 pm, 1.6 - 0.9 pm and 0.9 - <0.5 pm was calculated.

Analytical verification of test atmosphere concentrations:

no

Remarks:

concentration estimated at regular intervals during the exposure period, gravimetric method used, employed glass fibre filters (Gelman type A/E 25 mm)

Duration of exposure:

ca. 4 h

Concentrations:

5.0 mg/litre

No. of animals per sex per dose:

5 per sex and dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations hourly during exposure, immediately on removal from the restraining tubes at the end of the exposure, one hour after termination of the exposure and subsequently once daily for 14 days, bodyweights were recorded on the day of exposure, days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Using the mortality data obtained, an estimate of the acute inhalation median lethal concentration (LC50) of the test material was made.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.24 mg/L air

Exp. duration:

4 h

Remarks on result:

other: no mortality occurred

Mortality:

no mortalities

Clinical signs:

other: During exposure wet fur, decreased respiratory rate and test material staining of the fur were noted. On removal from the chamber animals additionally showed hunched posture, lethargy and pilo-erection. Laboured respiration and ptosis were common and ther

Body weight:

Expected bodyweight development was noted throughout the study

Gross pathology:

No abnormalities were detected at necropsy

Interpretation of results:

GHS criteria not met

Conclusions:

No deaths occurred in a group of ten rats exposed to a mean achieved concentration of 5.24 mg/litre (range 4.25 - 6.33 mg/litre). It was therefore considered that the acute inhalation median lethal concentration (LC50) of the test material in the Sprague-Dawley strain rat was greater than 5.24 mg/litre.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5.24 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Procedure and observations

A single dose of 5000 mg/kg bw dissolved in PEG was administrated to a group of 10 rats (5/sex/dose) by gavage (Ciba 1975). After treatment animals were observed for 14d and checked for clinical signs. All animals survived until scheduled necropsy; abnormalities or signs of toxicity were not observed. The feces of the treated animals was red stained throughout the study.

To evaluate the acute inhalative toxicity, male and female rats (5/sex/dose) were exposed for 4h to a dust aerosol of the analogue substance (range 4.25 - 6.33 mg/l air, nose only) (BASF 2010). Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing on day 1, 7 and 13 after treatment. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.

Discussion

Application of the test substance or an analogue via oral or inhalative route did not induce any signs of toxicity. None of the animals died due to treatment, viability and bodyweight gain were unaffected by the test article. The test item was not tested for acute dermal toxicity. With regard to the physico-chemical properties of the substance (pH, structure, solubility), the very limited skin penetration and the absence of systemic and local effects in acute oral and acute inhalation studies dermal toxicity is not likely.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).