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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

june 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented, GLP conform, limit dose is too low

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

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 material form:

solid: nanoform

Details on test material:

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: male 186 g, females 172 g
- Housing: groups of 5
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

4.13 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Evaluation of the particle size distribution revealed a mass median aerodynamic diameter of 1.9 micrometers and a geometric standard deviation of 2.3.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4.13 mg/L air

Mortality:

One male animal died due to an accident during exposure.

Clinical signs:

other: The animals showed irregular respiration, gasping, panting, bristling coat, stilted gait, uncoordinated gait, ataxic gait, trembling, sunken flanks and narrowed palpebral fissures. All clinical signs were reversible on day 7 of the study. The fur of the a

Gross pathology:

Autopsy of the animal, which died due to accident during exposure, revealed black discolouration of the lungs and dark discolouration of the liver.
Dissection of the animals killed at the termination of the study revealed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the present study, the 4-hour LC50 is thus greater than 4.13 mg / 1 air.