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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 - 18 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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:

male/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: at least 200 g
- Housing: during the exposure period: individually housing in suspended soli-floor polypropylene cages furnished with woodflakes; group housing for the remainder of the study period (groups of 5, by sex)
- 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 5 days

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

Administration / exposure

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: 10% of the total body surface area
- Type of wrap if used: Self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.68 mL/kg

Duration of exposure:

24 h

Doses:

2000 mg/kg

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: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 h after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight was recorded prior to application of the test substance on Day 0, and on Day 7 and 14; test sites were examined for evidence of primary irritation and scored according to the Draize system

Results and discussion

Effect levels

Key result

Sex:

male/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.

Other findings:

There were no signs of dermal irritation (all scores = 0).

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 dermal toxicity study a LD50 value > 2000 mg/kg bw in male and female rats was found.