Alkenes, C15-18 α-, sulfurized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 December 2012 to 3 January 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF, 12 Nohsan, Notification No. 8147, 2011; including the most recent partial revisions

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C15-18 α-, sulfurized

EC Number:

267-023-8

EC Name:

Alkenes, C15-18 α-, sulfurized

Cas Number:

67762-55-4

Molecular formula:

Not applicable, complex UVCB

IUPAC Name:

Alkenes, C15-18 α-, sulfurized

Test material form:

other: liquid (unspecified)

Details on test material:

- Appearance: red-brown liquid
- Storage conditions: room temperature in the dark
- Stability under storage conditions: stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Crl:WI (Han) (outbred, SPF-Quality).
- Age at study initiation: Approximately 10 weeks old.
- Weight at study initiation: 173 to 186 g on the first day of the test. Bodyweight variation did not exceed ± 20 % of the sex mean.
- Fasting period before study: Yes. Animals were deprived of food overnight prior to dosing and until 3 to 4 hours after administration of the test material.
- Housing: Group housing of 3 animals per cage in labelled cages containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 °C.
- Humidity (%): 40 to 70 %.
- Air changes (per hr): Approximately 15 room air changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle.

IN-LIFE DATES: From: 13 December 2012 To: 3 January 2013

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.247 mL/kg bodyweight.
Specific gravity of the test material was 0.89 at 15.6 °C. Therefore the dose volume was calculated as dose level (g/kg) / specific gravity (g/mL).

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

6 female animals; dosed in two groups of 3.

Control animals:

no

Details on study design:

The test material was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were weighed on day 1 (prior to dosing) and on days 8 and 15.
At periodic intervals on the day of dosing and once daily thereafter clinical signs were noted. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: Yes. At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure. Descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality.

Clinical signs:

other: Hunched posture was noted in all animals on day 1. Piloerection was also noted on the first day in one animal.

Gross pathology:

Rupture of the right and left medial lobe of the liver and watery-clear, dark red contents in the abdominal cavity were noted in one animal at macroscopic post mortem examination.
Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the oral LD50 of the test material was established to be >2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.

Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF 12 Nohsan, Notification No. 8147 under GLP conditions.

The undiluted test material was administered by gavage to two groups of three female Wistar rats at a limit dose level of 2000 mg/kg. The animals were observed for 15 days before being subjected to necropsy.

No mortality was seen throughout the study; hunched posture was noted in all animals on day 1 and piloerection was also noted on the first day in one animal. Bodyweight gains were considered to be normal. Rupture of the right and left medial lobe of the liver and watery-clear, dark red contents in the abdominal cavity were noted in one animal at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities.

Under the conditions of this study, the oral LD50 of the test material was established to be >2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.