2,2'-thiodiethanethiol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3-bis((2-mercaptoethyl)thio)-1-propanethiol

EC Number:

411-290-7

EC Name:

2,3-bis((2-mercaptoethyl)thio)-1-propanethiol

Cas Number:

131538-00-6

Molecular formula:

C7 H16 S5

IUPAC Name:

2,3-bis((2-mercaptoethyl)thio)-1-propanethiol

Test material form:

solid - liquid: suspension

Details on test material:

- Lot/batch No.: B-DMPT-EC1-05/2010-F4/2

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Animals, Inc. Denver, Pennsylvania
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: at least 8 weeks
- Weight at study initiation: Males: 2.4-2.5 kg; Females: 2.2-2.6 kg
- Housing: Individually housed, suspended, stainless steel with wire mesh bottoms.
- Diet (e.g. ad libitum): Lab Rabbit Chow HF (Purina #5326), ad libitum (125 g/day, while on test)
- Water (e.g. ad libitum): Automatic watering system, ad libitum. Municipal water supply (Elizabethtown Hater Co.).
- Acclimation period: 30 days
- Method of randomisation in assigning animals to test and control groups: Animals were randomly placed in cages upon receipt, and were placed on study as available at the time of study initiation. Any animals considered unsuitable because of poor health or outlying body weights were excluded from selection.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature: monitored and recorded twice daily.
- Humidity (%): Humidity: monitored and recorded daily.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: approx. 10% of the body surface area.
- Type of wrap if used: A layer of 8-ply gauze was then wrapped around the animal to cover the application site. The animal was then wrapped in an impervious plastic sleeve designed to contain the test material without leakage or undue pressure. The sleeve was secured with tape and Elizabethan collars.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following approximately 24 hours of exposure, the wrappings were removed and the test site wiped free of excess test material with dry
paper towels.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.6 mL/kg
- Concentration (if solution): 1269 mg/mL
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

- 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:
Viability check:
Twice Daily
Observations of Pharmacologic and Toxicologic Signs
Approximately 1, 2 and 4 hours after dosing and daily thereafter for fourteen days.
C. Body weights:
Day -1(at time of clipping; weights used for calculation of doses).
Pre-test (just prior to dosing)
Days 7 and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight

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:

No Mortality observed

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The majority of animals exhibited weight losses or no weight change at Day 7 and/or 14.

Gross pathology:

Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the present study 4-mercaptomethyl-3,6-dithia-1,8-'octanedithiol was dermally administered to 10 New Zealand White rabbits (male/female) at a concentration of 2000 mg/kg bw. All animals survived throughout the study. The majority of animals exhibited weight losses or no weight change at Day 7 and/or 14. No significant dermal or systemic toxicity was seen throughout the study, although one animal exhibited ocular redness, discharge and opacity throughout the study. Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variations.Therefore, the dermal LD50 of the test item in rabbits is greater than 2000 milligrams per kilogram of body weight.

Executive summary:

In an acute dermal toxicity study according to OECD test guideline 402 (1987), groups of young adult New Zealand White rabbits (5/sex) were dermally exposed to 2,3-bis((2-mercaptoethyl)thio)-1-propanethio for 24 hours to 10 % of the body surface area at a dose 2000 mg/kg bw. Animals then were observed for 14days.

Limit test

2,3-bis((2-mercaptoethyl)thio)-1-propanethiol is of low Toxicity based on the obtained results. No animal died during the Study and clinical signs were only marginal and reversible except for one male animal, thus a LD50 value could not be determined.