Alkali salt of sulfonated aryl azo amino sulfonyl aryl azo sulfonyl aryl azo aryl sulfonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Version / remarks:

2009

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reactive Brown DYHY 0331/0334

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Beijing Vital River Laboratory Animal Technology Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 54 to 60 days
- Weight at study initiation: 185 to 233 g for male rats and 165 to 173 g for female rats
- Fasting period before study: NA
- Housing: One or two animals were housed per cage during the acclimatization period. Animals were housed individually after exposure
- Diet (ad libitum): rodent complete nutrition pellet diet supplied by Beijing keaoxieli Feed CO., LTD. (Batch numbers: 18053211; 18073231)
- Water (ad libitum): purified tap water using the HT-R01000 purity system
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1°C to 24.6°C (Target value: 19°C to 25°C)
- Humidity (%): 46% to 75% (Target value: 40% to 70%)
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: July 31, 2018 to August 14, 2018

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

>= 1 - <= 4 µm

Geometric standard deviation (GSD):

>= 1.5 - <= 3

Details on inhalation exposure:

Equipment: HOPE-MED 8052H dynamic snout only dust inhalation instrument was used.
Exposure Method
Before exposure, each rat was restrained in a confined transparent polyacrylic tube. The exposure tubes were installed in the portholes of the inhalation chamber and the chamber was sealed up. Filtered and compressed air was mixed quantitatively with test item and the aerosol was sent to the exposure chamber (0.04 m³). The test item moving speed and exposure airflow rate had been adjusted to provide the selected target concentration. The aerosol was continuously generated by the generation system on the top of the chamber with an aerosol producer. A slight negative pressure was maintained in the outer plenum of the chamber to prevent leakage of the test substance into the surrounding area. The exhausted air was removed from the outlet at the bottom of the chamber and led to the absorption unit.

The actual concentrations, particle size distribution at the animals’ breathing zone, chamber airflow, chamber temperature, relative humidity and oxygen concentration were determined during the exposure period.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Designed dose (mg/m³): 5000
Actual concentration (mg/m³): 5030

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were recorded once during the exposure and twice (with about one hour interval) after exposure on the exposure day and then once daily for up to the end of the observation period.
Mortality inspections were made twice daily, morning and afternoon, during normal working days and once daily at weekends and public holidays.
The animals were weighed within the first 24 hours after arrival, on the day of exposure prior to exposure (day 0), and on day 1, day 3, day 7 and day 14.
- Necropsy of survivors performed: yes

Statistics:

The mean and standard deviation of body weight and body weight gains at different times were calculated.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 000 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

none

Clinical signs:

other: none

Body weight:

no effects

Gross pathology:

no effects

Other findings:

Actual Concentration
Actual mean concentration in the cabinet for four times measurement was 5030±58 mg/m³.
Nominal concentration in the cabinet was 53827 mg/m³.

Exposure Chamber Parameters
The air flow rate was 1.08 m³/h.
Temperature, humidity, oxygen and carbon dioxide concentration all met the acceptance criteria.

Particle Size Distribution
The mass median aerodynamic diameters (MMAD) for two measurements were 1.88 μm and 2.04 μm.
The geometric standard deviations (GSD) were 2.29 and 2.35, respectively.
The aerodynamic particle sizes less than 4 micron (mass %) for two measurements were 99.75% and 99.74%, respectively.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, the acute inhalation LC50 in SD rats for Reactive Brown DYHY 0331/0334 is higher than 5030±58 mg/m³ and it is classified as “unclassified” according to GHS classification.

Executive summary:

The study was designed to assess the acute inhalation toxicity of Reactive Brown DYHY 0331/0334 after being snout only administrated to SD rats for 4 hours and to make GHS classification.

The method was designed to meet the OECD Guideline for the testing of chemicals: Acute Inhalation Toxicity – Acute Toxic Class Method (No.436, 07 September 2009). 6 animals (3 males and 3 females) were exposed for 4 hours using a snout-only exposure system to 5030 mg/m³ ^{test item}. Clinical observations were made once during exposure and twice after exposure on the dosing day and then once daily in 14 days observation period. Body weights were weighed on day 0, day 1, day 3, day 7 and day 14. Concentrations were analysed four times and particle size distributions were measured two times during exposure. Gross necropsy was made to all animals at the end of observation.

No animals were found dead during test period and the mortality was zero. No abnormalities were found during the whole observation period. The body weight development of male and female animals during the observation period was regular. No abnormalities were found in female and male animals at the gross necropsy.

Actual mean concentration in the cabinet resulting from the four times measurement was 5030±58 mg/m³. The mass median aerodynamic diameters (MMAD) from the two measurements were 1.88 μm and 2.04 μm. The geometric standard deviations (GSD) were 2.29 and 2.35, respectively. The aerodynamic particle sizes less than 4 micron (mass %) for the two measurements were 99.75% and 99.74%, respectively.

 

Based on the results, the acute inhalation LC₅₀ in SD rats for Reactive Brown DYHY 0331/0334 is more than 5030±58 mg/m³ and it is classified as “unclassfied”