Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 September 2020 thru 14 October 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts

Molecular formula:

C33H66N3S6Sb to C51H102N3S6Sb

IUPAC Name:

Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts

Test material form:

liquid: viscous

Specific details on test material used for the study:

PYSICAL DESCRIPTION: Highly viscous amber liquid.

PURITY: >99%

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: WT05-19
- Expiration date of the lot/batch: not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp.
- Stability under storage conditions: stable for the duration of testing.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Charles River Laboratories on September 10, 2020
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult (8-9 weeks)
- Weight at study initiation: 175.1 - 208.1 grams
- Fasting period before study: Yes, overnight
- Housing: In caging which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011)
- Diet (e.g. ad libitum): Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum, except during fasting
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum
- Acclimation period: 7-20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 51 - 56
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours

IN-LIFE DATES: From: To: September 17 - October 14, 2020

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Limit Dose: 2000 mg/kg-bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 0, 7, and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight: 30 min post-dosing, then each hour for several hours, then daily for 14 days
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No

Statistics:

Statistical analysis was limited to the calculation of the mean density value for dosing.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed throughout the study.

Clinical signs:

other: Normal; all animals active and healthy throughout the study.

Gross pathology:

Normal

Any other information on results incl. tables

Animal No.	Sex	Dose Level (mg/kg)	Body Weight (g)			Dose
			Initial	Day 7	Day 14	mL
3101	F	2000	175.1	205.4	227.2	0.72
3102	F		185.3	200.6	205.1	0.76
3103	F		199.1	216.8	244.8	0.81
3104	F		200.7	230.6	244.2	0.82
3105	F		208.1	241.7	256.7	0.85

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The Oral LD50 for the test substance is >2000 mg/kg-bw.

Executive summary:

In an OECD 425 Guideline study conducted under GLP conditions using a limit dose of 2000 mg/kg-bw, no mortalities, changes in body-weight gain, clinical signs of toxicity, or abnormal findings in gross pathology were observed. Therefore, it can be concluded that the oral LD50 for the test substance is > 2000 mg/kg-bw.