3-[(3-sulfanylbutanoyl)oxy]-2,2-bis{[(3-sulfanylbutanoyl)oxy]methyl}propyl 3-sulfanylbutanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Jan - 19 Feb 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

No analytical purity is given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-{[(3R)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3R)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3R)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3R)-3-sulfanylbutanoyl]oxy}-2-({[(3R)-3-sulfanylbutanoyl]oxy}methyl)-2-({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3S)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3S)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3S)-3-sulfanylbutanoate

EC Number:

700-255-4

Cas Number:

31775-89-0

Molecular formula:

C21H36O8S4

IUPAC Name:

3-{[(3R)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3R)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3R)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3R)-3-sulfanylbutanoyl]oxy}-2-({[(3R)-3-sulfanylbutanoyl]oxy}methyl)-2-({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3S)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3R)-3-sulfanylbutanoate; 3-{[(3S)-3-sulfanylbutanoyl]oxy}-2,2-bis({[(3S)-3-sulfanylbutanoyl]oxy}methyl)propyl (3S)-3-sulfanylbutanoate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdRccHan®™:WIST®™

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 174 - 192 g
- Fasting period before study: Overnight fast immediately before dosing
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK; ad libitum
- Water: drinking water; ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.68 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.

Doses:

Starting dose: 2000 mg/kg
Additional group: 2000 mg/kg

No. of animals per sex per dose:

Starting dose: 1 female
Additional group: 4 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths noted.

Clinical signs:

other: There were no signs of systemic toxicity noted.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Table 1.  Individual Body weights and Body weight Changes

Dose Level mg/kg	Animal Number and Sex	Body weight (g) at Day			Body weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	192	211	221	19	10
	2-0 Female	192	199	209	7	10
	2-1 Female	188	194	205	6	11
	2-2 Female	174	189	204	15	15
	2-3 Female	189	185	197	-4	12

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study a LD50 value > 2000 mg/kg bw in female rats was found.