Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

August 3rd to 16th, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Reliability of the original study is 1

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Study design is based on OECD Guideline 401 (1987). Study design appears to follow OECD Guideline 423 (2001) with limit test at 5000 mg/kg bw. Contains sufficient detail to suggest GLP-like characteristics, but no statement of certification (reasonably thorough description of authors, dates, design, results and interpretation).

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl 3,3'-thiodipropionate

EC Number:

204-614-1

EC Name:

Didodecyl 3,3'-thiodipropionate

Cas Number:

123-28-4

Molecular formula:

C30H58O4S

IUPAC Name:

Didodecyl 3,3'-sulfanediyldipropanoate

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, Sisseln, Switzerland.
- Age at study initiation: 7 - 8 weeks.
- Weight at study initiation: 163 - 184 g.
- Fasting period before study: overnight prior to dosing.
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland).
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C.
- Humidity: 55 ± 15 %.
- Air changes: 15 per hr
- Photoperiod: 12hrs dark / 12hrs light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: CMPS80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

5000 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: daily (mortality and symptoms); on days 1, 7, 14, and at death (weight).
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight.

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Dispnea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6. The animals recovered within 11 days.

Gross pathology:

No compound related gross organ changes were observed

Applicant's summary and conclusion

Interpretation of results:

other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008

Conclusions:

LD50 (male, female rats) > 5000 mg/kg bw

Executive summary:

The acute toxicity of the test material to rats was evaluated in a limit test according to the OECD Guideline 401. Five male and five female rats were administered with the substance at 5000 mg/kg bw. The rats were observed daily for mortality and clinical signs and were weighed on days 1, 7, 14, and at death. The survived animals were necropsied.

No compound related gross organ changes an no significant bodyweight changes were observed. Dispnea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6 was observed. The animals recovered within 11 days.

LD50> 5000 mg/kg bw.