3,3'-thiodi(propionic acid)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Only translated summary available, actual guideline not stated.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only summary available, guideline not stated

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-thiodi(propionic acid)

EC Number:

203-841-3

EC Name:

3,3'-thiodi(propionic acid)

Cas Number:

111-17-1

Molecular formula:

C6H10O4S

IUPAC Name:

3-[(2-carboxyethyl)sulfanyl]propanoic acid

Details on test material:

- Name of test material (as cited in study report): Thiodipropionic acid (TDPA), 3,3’-thiodipropionic acid; bis(2-carboxyethyl) sulfide; ß,ß-thiodipropionic acid; 3,3’-thiobis(propanoic acid); 4-thiaheptanedioic acid; diethyl sulfide 2,2’-dicarboxylic acid; thiodihydracrylic acid
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 5 weeks
- Weight at study initiation: males 133-150 g, females 111-126 g
- Fasting period before study: 18 h before until 3 h after dosing
- Housing: 5/cage
- Diet (e.g. ad libitum): solid feed for experimental animals (MF, Oriental Yeast Co. Ltd.), ad libitum
- Water (e.g. ad libitum): sterile-filtered and UV-radiated tap water, ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±15
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL in 0.5 % CMC-Na aqueous solution (CMC-Na, Wako Pure Chemical Industries; Water for injection: Otsuka Pharmaceutical Factory)
- Amount of vehicle (if gavage): 10 mL/kg bw, calculated based on the bodyweight determined immediately prior to administration.


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


DOSAGE PREPARATION (if unusual): Preparation of test substance suspension in CMC-solution 6 days in advance of administration.

Doses:

0, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Survival, appearance, mobility, and other abnormalities on administration day immediately prior to administration and 0.5, 1, 3, and 6 hours after administration, then once a day thereafter for the rest of the observation period; bodyweight was measured immediately prior to administration (day 1) and then on days 2, 4, 8, 10, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

F test was performed on bodyweights, in case of equal variance they were subjected to Student's t-test, in case of unequal variance they were subjected to Aspen-Welch's t-test. Significance level was 5 %.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No effects were observed.

Gross pathology:

No effects were observed.

Any other information on results incl. tables

The test substance does not need to be classified according to the criteria of DSD or CLP.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study equivalent to OECD TG 401, Crj: CD(SD) fasted rats (5/sex/dose) were orally administered with 0 (control) and 2000 mg/kg bw 3,3'-Thiobispropanoic acid in 0.5 % carboxymethyl cellulose by gavage. Animals were then observed for 14 d. No mortality occurred. No clinical signs were observed. There was no significant difference compared to controls. A low value for males in the treated group was found on day 8 due to food not being given to those animals from day 7 to day8. This observation was not attributed to test material administration. At necropsy, no macroscopic effects were observed. The LD50 was >2000 mg/kg bw.