2-Propanol, 1-butoxy-3-(2-propen-1-yloxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 March 2013 - 09 April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD test guidelines and in compliance with GLP guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Test material

Test material information

1

Reference substance name:

1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol

EC Number:

801-709-5

Cas Number:

53146-45-5

Molecular formula:

C10H20O3

IUPAC Name:

1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol

Specific details on test material used for the study:

Description: Brown Liquid
Batch: 12D25
Purity: 94.0%
Expiry Date: 30 January 2014
Storage Conditions: Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Testing facility
- Age at study initiation: 8-12 weeks
- Fasting period before study: Overnight fast, immediately before dosing and for approximately three to four hours after dosing
- Housing: Housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg for 300 mg/kg group. 2000 mg/kg group recieved test material as supplied, dose volume (2.08 mL/kg) was based on the specific gravity (0.976) of the test material.

Doses:

300 mg/kg (following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg)

No. of animals per sex per dose:

Main study (300 mg/kg): 4
Total (including sighting study): 6

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: 1/2, 1, 2, and 4 hours after dosing and then daily for up to 14 days;
weighing: on Day 0 (the day of dosing) and on Days 7 and 14 or at death (Individual body weights were recorded).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopic observations

Statistics:

The animal treated at a dose level of 2000 mg/kg was found dead one day after dosing. There were no deaths at a dose level of 300 mg/kg.

Results and discussion

Preliminary study:

Dose Level - 2000 mg/kg:
- The animal was found dead one day after dosing,
- Hunched posture and ataxia were noted,
- No body weight gain was noted,
- At necropsy dark liver and epithelial sloughing of the gastric mucosa were noted

Dose Level - 300 mg/kg:
- There were no deaths,
- Hunched posture was noted in the initial treated animal,
- All animals showed expected gains in body weight over the observation period,
- No abnormalities were noted at necropsy.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted in the additional four treated animals

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).