Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 June 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

traditional method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate

Cas Number:

85187-33-3

Molecular formula:

C26H19BrN4Na2O9S3

IUPAC Name:

Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature

Specific details on test material used for the study:

Lanasol Red 6G, Product No. 01-146394-100-0, Batch No. (DCT No. 8-0053) 78316/11

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 247 and 345 g
- Fasting period before study: 1 hour
- Housing: housed, individually, in suspended, wire bottom cages
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 74 ± 1
- Humidity (%): 45 to 55
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

air

Remark on MMAD/GSD:

None

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 3-neck, round-bottom, 250 ml Pyrex flask
- Source and rate of air: 0.5 liter of air per minute per rat.

Duration of exposure:

4 h

Remarks on duration:

None

Concentrations:

The average analytical concentration obtained was 0.42 ± 0.32 mg/L.

No. of animals per sex per dose:

None

Control animals:

not specified

Details on study design:

None

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.42 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions

Mortality:

No mortality observed.

Clinical signs:

other: Abnormal exposure at 3 to 4 h of exposure and upto 4 h post exposure in all animals. No abnormalities were noted during the 14-day post-exposure period.

Body weight:

No effects observed.

Gross pathology:

Gross pathological observations showed organs of all animals to be within normal limits.

Other findings:

No effects observed

Any other information on results incl. tables

The average mass median diameter of particles for the 4-hour exposure was 3.90 ± 0.44 µm. Abnormal respiration was noted during the last 2 hours of the 4-hour exposure for all animals. This condition persisted for the first 4 hours post-exposure; however, all animals appeared to be normal for the remainder of the post-exposure period. Abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LC50 of test substance was 0.42 ± 0.32 mg/l and was found to be non toxic via inhalation.

Executive summary:

An acute toxicity study via inhalation was performed in 10 laboratory rats (5 males & 5 females) initially weighing between 247 and 345 grams, for 4 hours via the inhalation route at an atmospheric concentration of 0.42 ± 0.32 mg/l, exhibited abnormal respiration for the last half of the exposure. This condition persisted for approximately 4 hours post-exposure. The test substance was generated as a dust using a 3-neck, round-bottom, 250 ml Pyrex flask. No abnormalities were noted during the 14-day post-exposure period. There was no mortality seen. No abnormalities were noted during the 14-day post-exposure period except abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals which was subsided from Day1 of observation period. Gross pathological observations showed organs of all animals to be within normal limits. 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 3.90 ± 0.44 µm. Gross pathological observations showed organs of all animals to be within normal limits. Based on the study results the LC50 of test substance (FAT 40066) was 0.42 ± 0.32 mg/l.