1,7-Naphthalenedisulfonic acid, 4-amino-3-[(1E)-2-(2,4-disulfophenyl)diazenyl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfophenyl)diazenyl]-, sodium salt (1:5)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed at a GLP laboratory in accordance with OECD, EU and US testing guidelines for the assessment of Acute Inhalation Toxicity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

EC Number:

811-858-8

Cas Number:

2149571-68-4

Molecular formula:

C22 H11 N6 O18 S5 .5Na

IUPAC Name:

pentasodium 4-amino-3-[(1E)-2-(2,4-disulfonatophenyl)diazen-1-yl]-5-hydroxy-6-[(1E)-2-(4-nitro-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

Test material form:

aerosol dispenser: not specified

Remarks:

migrated information: aerosol

Details on test material:

6.1. Test Item
6.1.1. Test Item Information
Identification K1600 black dye
Appearance Black powder
Batch G-152
Purity/Composition 99.03%
Test substance storage At room temperature
Stable under storage conditions until 31 December 2016 (retest date) (taken from label)

Study Specific Test Item Information
pH 8.6 at concentration of 20%



6.2. Vehicle Information
Solubility in vehicle:
• Water
20-23%
Stability in vehicle:
• Water
Stable
Stability for at least 6 hours at room temperature is confirmed
over the concentration range 20 to 200 mg/mL,

Test animals

Species:

rat

Strain:

other: Rat: Crl:WI(Han) (outbred, SPF-Quality)

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

ca. 4 h

Concentrations:

The time-weighted mean actual concentration was 5.1 ± 0.15 mg/L. The nominal concentration
(amount of test item used divided by the volume of pressurized air used) was 22 mg/L. The generation
efficiency (ratio of actual and nominal concentration) was 23%.

No. of animals per sex per dose:

5 (five)

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

discriminating conc.

Effect level:

ca. 5.1 mg/L air (analytical)

Based on:

test mat.

95% CL:

>= 4.95 - <= 5.25

Exp. duration:

4 h

Any other information on results incl. tables

The time-weighted mean actual concentration was 5.1 ± 0.15 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 22 mg/L. The generation efficiency (ratio of actual and nominal concentration) was 23%. The concentration was measured at time points (n=18) that were equally distributed over the exposure period, the results of which demonstrated that the item was sufficiently stable. The generation was interrupted on three occasions in order to remove test item deposits from the system. To compensate for these interruptions, the generation time was elongated by 4 minutes in order to achieve an actual exposure time of 240 minutes.

The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were

determined twice during the exposure period. The MMAD was 1.8 µm (gsd 2.1) and 1.4 µm (gsd 1.9).

Mortality

No mortality occurred.

Clinical Signs

No clinical signs indicating test item related toxicity were seen during and after exposure. Black and

blue staining by the test item of several body parts was seen throughout the observation period.

Body Weights

Overall body weight gain in males and females was within the range expected for rats of this strain

and age used in this type of study and were therefore considered not indicative of toxicity.

Macroscopic Findings

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The inhalatory LC50, 4h value of K1600 black dye in Wistar rats was established to exceed 5 mg/L

Based on these results K1600 black dye does not have to be classified and has no obligatory labelling
requirement for acute inhalation toxicity according to the Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and
Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures
(including all amendments).

Executive summary:

The study was carried out based on the guidelines described in: - OECD Guidelines, Section 4, Health Effects. No.403, "Acute Inhalation Toxicity", Sep 2009. - Commission Regulation (EC) No 440/2008, B.2. Acute Toxicity (inhalation), L142, May 2008. - EPA OPPTS 870.1300, Acute inhalation Toxicity. EPA 712-C-98-193, August 1998. - JMAFF Guidelines (2000), including the most recent revisions. K1600 black dye was administered as an aerosol by nose-only inhalation for 4 hours to one group of five male and five female Wistar rats. Generation as a dust was technically not possible and therefore the test item was mixed with water and generated as a liquid aerosol. Mortality and clinical signs were observed daily during the observation period and body weights were determined on Days 1, 2, 4, 8 and 15. Macroscopic examination was performed after terminal sacrifice (Day 15). The time-weighted mean actual concentration was 5.1 ± 0.15 mg/L. The nominal concentration (amount of test item used divided by the volume of pressurized air used) was 22 mg/L. The generation efficiency (ratio of actual and nominal concentration) was 23%. The concentration was measured at time points (n=18) that were equally distributed over the exposure period, the results of which demonstrated that the item was sufficiently stable. The generation was interrupted on three occasions in order to remove test item deposits from the system. To compensate for these interruptions, the generation time was elongated by 4 minutes in order to achieve an actual exposure time of 240 minutes. The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were determined twice during the exposure period. The MMAD was 1.8 µm (gsd 2.1) and 1.4 µm (gsd 1.9). No mortality occurred. No clinical signs indicating test item related toxicity were seen during and after exposure. Black and blue staining by the test item of several body parts was seen throughout the observation period. Overall body weight gain in males and females was within the range as expected for rats of this strain and age used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The inhalatory LC 50, 4h value of K1600 black dye in Wistar rats was established to exceed 5 mg/L. Based on these results K1600 black dye does not have to be classified and has no obligatory labelling requirement for acute inhalation toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).