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EC number: 213-192-8 | CAS number: 928-96-1
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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Acute Toxicity: oral
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:
- 1 979
- 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
- 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:
- 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
Constituent 1
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:
- other: Signs of reaction to treatment consisted of decreased motor activity, ataxia, unconsciousness, bradypnoea and diarrhoea. Survivors were asymptomatic from Day 2 until termination.
- 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.
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