Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 December 2017 - 5 April 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate

EC Number:

915-932-1

Molecular formula:

Reaction mass of C12H8O8S3.2K and C12H9O5S2.K

IUPAC Name:

Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

TEST SUBSTANCE IDENTIFICATION: KSS-FR
Lot #: KSS-1711-02
Composition: Reaction mass of dipotassium 3,3’-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate
KSS - 70.8%, CAS #63316-43-8
DKSS - 20.9%, CAS #63316-33-6
Other - 8.3%
Physical Description: White powder
pH: 7.11
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: November 2019

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult (9-10 weeks)/males 316-370 grams and females 189-221 grams at experimental start. The animals were singly housed in suspended stainless steel caging, which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

nose only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

3.04 µm

Geometric standard deviation (GSD):

2.6

Remark on MMAD/GSD:

The mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were calculated using two-cycle logarithmic probit axes.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Remarks on duration:

The exposure period was extended beyond 4 hours to allow the chamber to reach equilibrium (T99).

Concentrations:

The exposure chamber, air supply, and equipment used to measure particle size distribution, airflow, and chamber concentration were the same as used during the appropriate pre-test trials.

No. of animals per sex per dose:

5/sex

Control animals:

no

Statistics:

Statistical analysis was limited to the calculation of the mean and standard deviation..

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.09 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

None

Clinical signs:

other: All rats exhibited irregular respiration but recovered by day 3.

Body weight:

All animals gained body weight.

Gross pathology:

No gross abnormalities.

Other findings:

None

Any other information on results incl. tables

GRAVIMETRIC CHAMBER CONCENTRATIONS

Target Concentration (mg/L)	Sample Number	Time of Sample (hour)	Mass Collected (mg)	Airflow Sampled (Lpm)	Collection Time (min)	Exposure Concentration (mg/L)
5.0	1	0.5	20.5	4.0	1	5.13
	2	1	20.2	4.0	1	5.05
	3	2	20.1	4.0	1	5.03
	4	2.5	21.0	4.0	1	5.25
	5	3.5	20.2	4.0	1	5.05
	6	3.75	20.1	4.0	1	5.03
Average ± Standard Deviation						5.09 ± 0.09

NOMINAL CHAMBER CONCENTRATION

Exposure Concentration (mg/L)	Total Test Substance Used (g)	Total Airflow (Lpm)	Total Time of Exposure (min)	Nominal Concentration(mg/L)
5.09	145.8	40.0	241	15.12

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The 4-hour LC50 for male and female Sprague-Dawley rats was determined to be >5.09 mg/L.

Executive summary:

In a GLP Acute Inhalation (nose-only) guideline study with male and female Sprague-Dawley rats conducted according to OECD Guideline 403, OPPTS 870.1300, and EC method B.2, the 4 -hour LC50 was determined to be >5.09 mg/L. After establishing the desired generation procedures during the pre-test trials, ten healthy rats (5/sex) were exposed to the test atmosphere for 4 hours. Chamber concentration and particle size distributions of the test atmosphere were determined periodically during the exposure period. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days following exposure. Body weights were recorded prior to exposure (initial) and again on Days 1, 3, 7, and 14 (terminal). Necropsies were performed on all animals at terminal sacrifice. All animals survived exposure to the test atmosphere and gained body weight during the study. Following exposure, all rats exhibited irregular respiration. However, all animals recovered by Day 3 and appeared active and healthy for the remainder of the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. The gravimetric chamber concentration was 5.09 mg/L. The average mass median aerodynamic diameter was estimated to be 3.04 µm based on graphic analysis of the particle size distribution as measured with a 1 ACFM Andersen Ambient Particle Sizing Sampler with an average geometric standard deviation of 2.6.