C10-14-alkyl-1-(ethenyloxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 to 30 October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyoeisha chemical co., Bx 7080101
- Expiration date of the lot/batch: August 01, 2019
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (Ambient), Container was kept tightly closed and away from heat or sunlight
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

Test animals

Species:

rat

Strain:

other: RccHan : WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females: nulliparous and non-pregnant: yes
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: Minimum: 181.7g, Maximum: 206.8g
- Fasting period before study: Overnight prior to dosing and three hours post-dose.
- Housing: Three rats per cage . Polypropylene rat cages covered with a stainless steel grid top were used. Autoclaved clean rice husk was used as the bedding material.
- Diet (e.g. ad libitum): Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
- Water (e.g. ad libitum): Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle. UV sterilized water filtered through Reverse Osmosis water filtration system.
- Acclimation period: 6 to 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 49 to 66%
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod was maintained through an automatic timer)

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not applicable
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

300 and 2000 mg / kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 19 days
- Frequency of observations and weighing: Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14, with the exception of set II clinical signs and body weight which were also recorded on day 19.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Rats were observed twice a day for morbidity and mortality for a period of
14 days following oral dosing. Clinical signs were recorded once a day.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats treated with 300 or 2000 mg C10-C14 alkyl ether/kg body weight.

Clinical signs:

No clinical signs were observed in any rat treated with 300 or 2000 mg C10-C14 alkyl ether/kg body weight.

Body weight:

Normal gain in body weight was observed in all rats treated with 300 or 2000 mg C10-C14 alkyl ether/kg body weight.

Gross pathology:

In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at dose levels used in the present study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50 cut- off value) C10-C14 alkyl ether in Wistar rats was found to be 5000 mg/kg body weight. Based on the results of this study, the classification for C10-C14 alkyl ether is as follows: unclassified.