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Administrative data

Description of key information

Oral LD50 (rat): >2000 mg/kg

Inhalation LC50 (4 -hour, rat): >5.15 mg/L

Dermal LD50 (predicted, rat): >2000 mg/kg

No acute toxicity was observed up to the limit dose of 2000 mg/kg (Oral, rat) or 5 mg/L (4 -hour Inhalation, rat). Dermal toxicity is not expected given the absence of toxicity by the oral and inhalation routes coupled with the absence of significant dermal absorption.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 25 - February 12, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Composition: STB-FR (Benzenesulfonic acid, 2,4,5-trichloro-, sodium salt)
Lot #: 1710-06
Purity: 90.5%
CAS# 53423-65-7
EC# 258-548-3
Physical Description: White powder
pH: 7.11
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: October 2019
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
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. Temperature and relative humidity ranges were kept at 19-26ºC and 38-58% humidity, with a 12 hour light/dark cycle. The animals were fed, Envigo Teklad Global 16% Protein Rodent Diet® and filtered tap water. Available ad libitum.

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance, as received, was a powder. The test substance was administered as a 40% w/w mixture in distilled water. Preliminary sample preparation assessments conducted by PSL indicated that mixtures in excess of 40% (i.e., 50-80%) were too viscous to be administered properly. Each preparation was mixed well prior to use.
Doses:
Individual doses were calculated based on the initial body weights, taking into account the density and concentration of the test mixture
No. of animals per sex per dose:
5 female rats, given one dose of 2000 mg/kg each.
Control animals:
no
Details on study design:
The animals were observed for mortality, signs of gross toxicity, and behavioral changes approximately 30 minutes post-dosing, during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
Statistics:
Statistical analysis was limited to the calculation of the mean density value for dosing.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All rats survived testing and the 14-day observation period.
Clinical signs:
Apart from one female exhibiting irregular respiration for the first three hours following administration, there were no other signs of gross toxicity, adverse clinical effects, or abnormal behavior.
Body weight:
All animals gained body weight throughout the study.
Gross pathology:
No gross abnormalities were noted for any of the animals necropsied at the conclusion of the 14-day observation period.
Other findings:
None

INDIVIDUAL BODY WEIGHTS AND DOSES:

Animal No.

Sex

Dose Level (mg/kg)

Body Weight (g)

Dose1

Initial

Day 7

Day 14

mL

3101

F

2000

183

228

238

0.75

3102

F

200

240

255

0.82

3103

F

197

228

245

0.81

3104

F

194

219

254

0.80

3105

F

189

226

246

0.77

1The test substance was administeredas a 40% w/w mixture indistilled water. Density –1.220g/mL.

INDIVIDUAL CAGE-SIDE OBSERVATIONS:

Animal Number

Animal Sex

Dose Level (mg/kg)

Observation

Day of Observation (x=observation is present)

0(0.5 hr)

0(3 hrs)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

3101

F

2000

Irregular respiration

x

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Active and healthy

 

 

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

3102

F

2000

Active and healthy

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

3103

F

2000

Active and healthy

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

3104

F

2000

Active and healthy

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

 

3105

F

2000

Active and healthy

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

INDIVIDUAL NECROPSY OBSERVATIONS:

Animal Number

Animal Sex

Dose Level (mg/kg)

Organ / Tissue

Observation

3101

F

2000

All tissues and organs

No gross abnormalities

 

3102

F

2000

All tissues and organs

No gross abnormalities

 

3103

F

2000

All tissues and organs

No gross abnormalities

 

3104

F

2000

All tissues and organs

No gross abnormalities

 

3105

F

2000

All tissues and organs

No gross abnormalities

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 of the substance is greater than (>) 2000 mg/kg of body weight in female rats.
Executive summary:

In a GLP guideline study conducted according to OPPTS 870.1100, OECD Test No. 420, and EC method B.1 using the Acute Oral Fixed Dose Procedure, the acute oral LD50 of the test substance was determined to be greater than (>) 2000 mg/kg of body wieght in female Sprague-Dawley rats. All animals survived test substance administration and gained body weight during the study. Apart from one female exhibiting irregular respiration for the first three hours following administration, there were no other signs of gross toxicity, adverse clinical effects, or abnormal behavior. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Adequate

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 December 2017 - 21 February 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes
Specific details on test material used for the study:
Composition: STB-FR (Benzenesulfonic acid, 2,4,5-trichloro-, sodium salt)
Lot #: 1710-06
Purity: 90.5%
CAS# 53423-65-7
EC# 258-548-3
Physical Description: White powder
pH: 7.11
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: October 2019
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
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). Animal Room Temperature and Relative Humidity Ranges were recorded at 20-26ºC and 45-59%, respectively.
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
3.36 µm
Geometric standard deviation (GSD):
2.46
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetric
Duration of exposure:
4 h
Concentrations:
5.15 mg/L +/- 0.25
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
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.
Statistics:
Statistical analysis was limited to the calculation of the mean and standard deviation.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.15 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: All rats exhibited irregular respiration upon removal from the exposure tube and at 1.5 hours post-exposure, but recovered by Day 1 and appeared active and healthy for the remainder of the 14-day observation period.
Body weight:
All animals gained body weight throughout the the 14-day study period.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

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

20.6

4.0

1

5.15

2

1.0

22.0

4.0

1

5.50

3

2.0

19.3

4.0

1

4.83

4

2.5

20.0

4.0

1

5.00

5

3.5

20.1

4.0

1

5.03

6

3.75

21.5

4.0

1

5.38

Average ± Standard Deviation

5.15 ± 0.25

SUMMARY OF PARTICLE SIZE DISTRIBUTION:

Sample No.

Time of

Sample

(hours)

Collection

Time

(minutes)

Mass Median Aerodynamic Diameter

(µm)

Geometric Standard Deviation

1

1.5

1

3.34

2.47

2

3

1

3.38

2.44

Average

3.36

2.46

Interpretation of results:
GHS criteria not met
Conclusions:
The 4-hour LC50 for male and female Sprague-Dawley rats was determined to be >5.15 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 >5.15 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 1 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 5.15 mg/L. The average mass median aerodynamic diameter was estimated to be 3.36 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 2.46.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Adequate

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Adequate: Dermal toxicity is not expected given the absence of toxicity by the oral and inhalation routes coupled with the absence of significant dermal absorption.

Additional information

Justification for classification or non-classification

Not Classified for Acute Toxicity: No acute toxicity was observed up to the limit dose of 2000 mg/kg (Oral, rat) or 5 mg/L (4 -hour Inhalation, rat). Dermal toxicity is not expected given the absence of toxicity by the oral and inhalation routes coupled with the absence of significant dermal absorption.