Sodium 2,4,5-trichlorobenzenesulphonate

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 3

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

Test material information

Constituent 1

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-trichlorobenzenesulfonate

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:

other: 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.

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)			Dose^1
			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.