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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2,4,5-trichlorobenzenesulphonate
EC Number:
258-548-3
EC Name:
Sodium 2,4,5-trichlorobenzenesulphonate
Cas Number:
53423-65-7
Molecular formula:
C6H2Cl3O3S.Na
IUPAC Name:
sodium 2,4,5-trichlorobenzene-1-sulfonate
Test material form:
solid: particulate/powder
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system 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.

Administration / exposure

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.

Results and discussion

Effect levels
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.