Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethoxypropanol
- Molecular formula (if other than submission substance):
- Physical state: Liquid
- Analytical purity: 91.1%
- Impurities (identity and concentrations):
8.0% 2-ethoxy-1-propanol
0.7% 1-methoxy-2-propanol
0.1% 2-methoxy-1-propanol
0.04% 1-(2-propenyloxy)-2-propanol
- Purity test date: 6 June 1983
- Lot/batch No.: Batch No. 96 from BP Chemie, Lavera
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Each animal was uniquely identified by ear notching.

TEST ANIMALS
- Source: Charles River UK Ltd, Kent, England
- Age at study initiation: Approximately 6 weeks when received
- Weight at study initiation: Males: 210 – 235 g, Females: 165 – 180 g
- Housing: Animals were housed in groups of three or less in polypropylene cages with stainless steel grid tops and floors.
- Diet: Ad libitum access to No. 1 pelleted expanded maintenance diet from Special Diet Services Ltd, Essex, England.
- Water: Ad libitum access to water supplied by the North Surrey Water Company
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Targeted values were 20 + 1 degree C.
- Humidity: Targeted values were 55 + 15 % relative humidity.
- Air changes: Approximately 15 changes per hour.
- Photoperiod: 14-hour light: 10-hour dark cycle.

IN-LIFE DATES: From: June 2, 1984 To: June 21, 1984

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2 ml/kg in the main study

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Pilot study
Doses:
2 ml/kg in main study.
No. of animals per sex per dose:
Pilot study – 1 male and 1 female
Main study – 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration:
Pilot study – 24 hours
Main study – 14 days
- Frequency of observations and weighing: Animals were observed at approximately 5, 30, 60 and 180 minutes after dosing, and at least twice daily on subsequent days. Individual body weights were recorded on Days 0, 2, 7 and 14 of the main study.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were recorded at each observation interval. Each animal was subject to a detailed macroscopic examination including opening the abdominal, thoracic, and cranial cavities. The appearance of all organs was noted in situ and all abnormalities recorded; the cut surfaces of the liver and kidneys were examined.
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 mL/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Mortality:
There were no mortalities.
Clinical signs:
Transitory slight piloerection was seen in all animals on Days 1, 7 and 13. Slight staining of the fur of the head and ears was noted in two female rats on the day of autopsy.
Body weight:
A slight transitory reduction in bodyweight gain occurred in females animals between Days 0 – 2.
Gross pathology:
Postmortem findings were considered unrelated to treatment.
Other findings:
no other findings reported

Any other information on results incl. tables

All animals survived the 24-hour pilot study at doses of 2 ml/kg or 5 ml/kg.  Transitory salivation, inactivity, unsteady gait, rapid respiration, staining of the fur in the urinogenital region, partial ptosis, hunched posture and prostration were seen in animals treated with ethoxypropanol at 5 ml/kg.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal oral dose to rats of ethoxypropanol was greater than 2.0 ml/kg bodyweight.
Executive summary:

In a GLP acute oral toxicity study in rats, a single dose of ethoxypropanol administered by gavage at a dose of 2.0 ml/kg (1792 mg/kg) did not produce lethality.  Apart from transitory reduction in the bodyweight gain of female rats, there were no clear signs of toxicity seen at this dose level.