cis-2-methyl-4-propyl-1,3-oxathiane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22-06-2006 to 13-07-2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected: August 2003; signature: November 2005

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

cis-2-methyl-4-propyl-1,3-oxathiane

EC Number:

261-699-8

EC Name:

cis-2-methyl-4-propyl-1,3-oxathiane

Cas Number:

59323-76-1

Molecular formula:

C8H16OS

IUPAC Name:

2-methyl-4-propyl-1,3-oxathiane

Test material form:

liquid

Details on test material:

- Physical state: Liquid
- Storage condition of test material: approximately 4°C under nitrogen
- Other: Colourless

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 206 - 250 g
- Fasting period before study: Overnight
- Housing: The animals were housed 2/cage in 3 suspended solid-floor polypropylene cages furnished with woodflakes
- Water: ad libitum
- Acclimation period: Five (5) days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 (controlled)
- Humidity (%): 30-70 (controlled)
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark

IN-LIFE DATES: From: 22-06-2006 To: 13-07-2006

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg was chosen as the
starting dose.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to and then 0.5, 1, 2, 4 hours after dosing; once daily. Individual bodyweights prior to and at 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal was found dead two days after dosing.

Clinical signs:

other: Signs of systemic toxicity noted during the study were hunched posture, lethargy, ataxia, piloerection, ptosis, decreased respiratory rate, pallor of the extremities, loss of righting reflex and laboured and noisy respiration. The surviving animals appear

Gross pathology:

The animal that died during the study was found cannibalised, a necropsy was therefore not performed. No abnormalities were noted at necropsy of animals that were euthanized at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test item oral median LD50 was estimated to be 2500 mg/k:g bw in female Sprague-Dawley CD strain rat.

Executive summary:

The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity and according to GLP to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat by the acute class method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. One animal was found dead two days after dosing. Signs of systemic toxicity noted during the study were hunched posture, lethargy, ataxia, pilo-erection, ptosis, decreased respiratory rate, pallor of the extremities, loss of righting reflex and laboured and noisy respiration. The surviving animals appeared normal four or five days after dosing. The surviving animals showed expected gains in bodyweight over the study period. The animal that died during the study was found cannibalised, a necropsy was therefore not performed. No abnormalities were noted at necropsy of animals that were humanely euthanized at the end of the study. The acute toxicity estimate was >2000 - 5000 mg/kg bw. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be 2500 mg/kg bw.