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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 guidelineopen allclose all
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 (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

Constituent 1
Chemical structure
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.