Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 August- 29 August 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute oral toxicity of the test substance, prepared as solutions of varying concentration in corn oil to allow treatment at a constant volume-dosage of 20 ml/kg, was investigated in groups of fasted male and female rates, within the dosage range 2000- 5000 mg/kg. Animals were dosed by gavage.
GLP compliance:
no
Remarks:
Study predates GLP
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
cis-hex-3-en-1-ol
EC Number:
213-192-8
EC Name:
cis-hex-3-en-1-ol
Cas Number:
928-96-1
Molecular formula:
C6H12O
IUPAC Name:
(3Z)-hex-3-en-1-ol
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): cis-3-hexen-1-ol
- Physical state: clear, liquid

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: about 1 month old
- Weight at study initiation: 103- 134 g for males and 94- 119 g for females
- Housing: 5 to a cage (in pairs for preliminary studies) in high density polypropylene cages suspended in racks manufactured by North Kent Plastics Limited. Cages measured 50 x 30 x 18 cm high and were fitted with stainless steel grid floors to facilitate rapid removal of waste material to undertrays, cleaned as necessary. Cages were fitted in the racks in such a way that possible environmental influences arising from their spatial distribution were equilibrated, as far as possible, for each treatment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 2 °C
- Humidity (%): 50 % ± 10 %
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses were determined according to the fasted bodyweight of animals at the time of dosing. From the results of the preliminary study, main study doses were selected; if the LD50 was less than the maximum practicable single dosage of 5000 mg/kg then groups of 10 animals, evenly divided by sex, would be allocated to 5 different dose-levels separated by a constant geometric progression to cover the presumed LD50. Should all animals survive the maximum practicable dosage, or less than 50 % die, the value of the LD50 would be regarded as lying in excess of this dosage.
Doses:
Preliminary study: 100, 500, 1000, 3000 and 5000 mg/kg
Main study: 2000, 2515, 3162, 3976 and 5000 mg/kg
No. of animals per sex per dose:
Preliminary study: 2/sex/ dose
Main study: 5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed frequently during the first 6 hours after dosing and at least daily thereafter for any signs of reaction to treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The 95% confidence limits were calcaulted by probit analysis.

Results and discussion

Preliminary study:
From the results of the preliminary study, the LD50 was expected to be around 5000 mg/kg. The main sign of reaction to treatment was a decrease in motor activity. Necropsy of decedents revealed signs of gastro-intestinal irritation.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 615 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 045 - <= 6 265
Mortality:
11 deaths occured, all within 2.5 hours of dosing.
Clinical signs:
Signs of reaction to treatment consisted of decreased motor activity, ataxia, unconsciousness, bradypnoea and diarrhoea. Survivors were asymptomatic from Day 2 until termination.
Body weight:
Normal bodyweight changes were recorded for survivors over the 14 d period of observation.
Gross pathology:
Necropsy of decedents revealed staining of fur, and fluid and mucoid dilation of the gastro-intestinal tract. Thymic congestion, lung congestion and fluid-filled thoracic cavity occurred in 1 animal.

Necropsy of Day 15 revealed no significant lesions.

Any other information on results incl. tables

See Attachment 1 for further details regarding the distribution of signs and mortality among groups of male and female rats given a single oral dosage of the test substance, at a volume-dosage of 20 ml in corn oil.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The test substance was assessed for acute toxicity via the oral route, administerd by gavage as solutions of varying concetrations in corn oil. The test substance was found to have a LD50 of 4615 mg/kg. Therefore, under the conditions of this study the test substance was not considered to be acutely toxic via the oral route.
Executive summary:

The acute oral toxicity of the test item, prepared as solutions of varying concentration on corn oil to allow treatment at a constant volume-dosage of 20 mL/kg, was investigated in groups of fasted male and female rats of the Charles River CD strain, within the dosage range 2000- 5000 mg/kg. Mortality and signs of reaction to treatment were recorded during a 14 -day period of observation. Decedents and survivors killed on Day 15 were subjected to necropsy.

Signs of reaction to treatment consisted of decreased motor activity, ataxia, unconsciousness, bradypnoea and diarrhoea. Eleven deaths occurred, all within 2 ½ h of dosing. Survivors were asymptomatic from Day 2 until termination.

Necropsy of decedents revealed staining of fur and, fluid and mucoid dilation of gastro-intestinal tract. Thymic congestion, lung congestion and fluid-filled thoracic cavity occurred in 1 animal.

Normal bodyweight changes were recorded for survivors over the 14-d period of observation. Necropsy of Day 15 revealed no significant lesions.

From the observed mortality data, the acute median lethal oral dosage (LD50) and 95 % confidence limits, calculated by probit analysis is 4615 (4045- 6265) mg/kg.