Dioctadecyl disulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov - Dec 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable; study equivalent to OECD Guideline 401 with minor deviation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only females tested

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dioctadecyl disulphide

EC Number:

219-702-5

EC Name:

Dioctadecyl disulphide

Cas Number:

2500-88-1

Molecular formula:

C36H74S2

IUPAC Name:

dioctadecyl disulphide

Constituent 2

Reference substance name:

Di-n-octadecyl disulphide

IUPAC Name:

Di-n-octadecyl disulphide

Constituent 3

Reference substance name:

Hostanox SE 10

IUPAC Name:

Hostanox SE 10

Test animals

Species:

rat

Strain:

other: Hoechst AG Kastengrund - SPF breed

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 93 - 107g
- Fasting period before study: 16 hours before and 2 hours after application
- Housing: in plastic cages, softwood pellets
- Diet (e.g. ad libitum): Altromin 1324 (Altrogge GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- concentration in vehicle: 25 % (w/v)

Doses:

15000 mg/kg bw

No. of animals per sex per dose:

10 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

no

Results and discussion

Preliminary study:

An acute oral toxicity study with female rats was performed in 1964. The LD(50) dreived was 15000 mg/kg bw.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Remarks on result:

other: no effects

Mortality:

no deaths occured

Clinical signs:

other: no symptoms

Gross pathology:

no anomalies

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Hostanox SE 10 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.

Executive summary:

Hostanox SE 10 was tested for its acute toxic properties in female rat via oral route. No animal died or showed clinical symptoms/macroscopic anomalies after application of 15000 mg/kg bw.

Therefore, the median lethal dose of Hostanox SE 10 (LD50) was greater than 15000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.