Reaction product of disodium 4,4'-dinitrostilbene-2,2'-disulphonate, p-[(4-amino-2,5-xylyl)azo]benzenesulphonic acid, 3-[(4-amino-2-methoxyphenyl)azo]-4-hydroxybenzenesulphonic acid, copper (II) sulfate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 21, 1978 to May 5, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1979

Materials and methods

Principles of method if other than guideline:

4-Hour Acute Inhalation Toxicity in Rats in Accordance With the Regulations as Defined in the Protocol Submitted by Ciba-Geigy. Ten laboratory rats (5 males & 5 females) are exposed in a 40 liters (36 x 36 x 31 cm) glass exposure chamber, to the test substance via the inhalation route at an atmospheric concentration of 2.34 ± 0.26 mg/l for 4 hours.

GLP compliance:

no

Test type:

fixed concentration procedure

Test material

Test material information

Constituent 1

Reference substance name:

tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate

EC Number:

943-210-6

Molecular formula:

Not applicable. UVCB Substance

IUPAC Name:

tetrasodium 15-[(Z)-2-{4-[(E)-2-{4-[(E)-2-{2,5-dimethyl-4-[(E)-2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]-2-sulfophenyl}ethenyl]-3-sulfophenyl}diazen-1-yl]-10,12-dioxa-2,3-diaza-11-cupratricyclo[11.4.0.0^{4,9}]heptadeca-1(17),2,4,6,8,13,15-heptaene-6-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: no data- Weight at study initiation: 245 - 324 g- Housing: The animals were housed, individually, in suspended wire bottom cages- Diet: ad libitum- Water: ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 23 ± 1 °C- Humidity (%): 45-55 %- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTIONThis test was conducted in a 40 l (36 x 36 x 31 cm) glass exposure chamber. The sides and the bottom of the chamber had centred holes (3-4 cm in diameter) to allow access to the chamber for testing and exhaust of the atmosphere. The port in the bottom of the chamber was centred over a 10 cm hole in a wooden platform. A funnel (8.5 cm in diameter) was brought from the underside of the platform through the hole and centred on the port in the bottom of the chamber. Dynamic air flow within the chamber was maintained by connecting the funnel to a vacuum pump for continuous changing of the chamber atmosphere.- Exposure chamber volume: 40 l (36 x 36 x 31 cm) glass exposure chamber.- Source and rate of air: Dynamic air flow within the chamber was maintained by connecting the funnel to a vacuum pump for continuous changing of the chamber atmosphere.- System of generating particulates/aerosols: The test substance was generated as a dust using a 3-neck, round-bottom, 250 ml Pyrex flask. A stirring mechanism was placed through the center neck of the flask and an air line through one of the side necks. The third neck was connected by a glass elbow (which had an air vent to allow flushing) to the chamber. The dust was introduced into the chamber through a side port. A piece of rubber was taped over the outer area around the hole and a vertical slit made in the rubber to allow the entrance of the glass elbow from the dust generator. Constant flow of material was maintained by a calibrated flowmeter connected between the air line and the generating apparatus. In all instances, the air flow was maintained at or above 0.5 liter of air per minute per rat. - Method of particle size determination: Particle size determinations were made using a Cascade Impactor- Treatment of exhaust air: filter holder was attached to a vacuum pump which was regulated to exhaust 1.0 liter of air per minute from the chamber through the filterTEST ATMOSPHERE- Brief description of analytical method used: Measurement of the atmospheric concentration of test substance in the chamber was achieved using a Gelman Model 1235 stainless steel filter holder containing a pre-weighed glass fiber filter (Gelman type AE-47 mm).

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

2.34 ± 0.26 mg/l

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: 4 times for clinical signs. All animals were weighed prior to the initiation of the exposure and on days 1, 7 and 14 following exposure. - Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 2.34 mg/L air (analytical)

Based on:

test mat.

95% CL:

ca. 0.26

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 2.106 mg/L air (analytical)

Based on:

act. ingr.

95% CL:

ca. 0.26

Exp. duration:

4 h

Mortality:

no mortality observed

Clinical signs:

other: abnormal respiration was noted during the first 2 hours post-exposure. This condition was not noted 4 hours post-exposure and animals appeared normal for the remainder of the observation period.

Body weight:

Eight animals (4 males and 4 females) showed slight weight losses on day one; however, all animals were gaining weight normally for the remainder of the observation period.

Gross pathology:

The results of the gross pathological examinations showed that organs of all rats were within normal limits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not classified according to CLP Regulation (EC n. 1272/2008)

Conclusions:

The test substance shows no adverse effect at concentration of 2.34 mg/l (2.10 mg/l based on active ingredient).

Executive summary:

The substance has been tested for acute toxicity via inhalation route. Ten laboratory rats (5 males and 5 females) initially weighing between 245 and 324 grams, when exposed to test substance via the inhalation route at an atmospheric concentration of 2.34 ± 0.26 mg/l for 4 hours, exhibited no observable adverse clinical signs during the exposure. Abnormal respiration was observed in all animals during the first 2 hours post-exposure. However, all animals appeared normal when observed 4 hours after the exposure. No abnormalities were noted during the 14-day post-exposure period, therefore the LC0 is 2.34 mg/l (2.10 mg/l based on active ingredient). The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions. The average mass median particle diameter was 8.04 ± 1.62 µm. Gross pathological observations showed organs of all animals to be within normal limits.