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EC number: 203-691-9 | CAS number: 109-65-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08/09/1993 to 22/09/1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- O.E.C.D. guideline No. 401, 24 February 1987.
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-bromobutane
- EC Number:
- 203-691-9
- EC Name:
- 1-bromobutane
- Cas Number:
- 109-65-9
- Molecular formula:
- C4H9Br
- IUPAC Name:
- 1-bromobutane
- Test material form:
- liquid
- Details on test material:
- name:
protocol and labelling: n-BUTYL BROMIDE
batch number:
protocol and labelling: 5-241-1 / 0-201-1
Elf Atochem filing number: CAL 6777/95
description: colourless liquid
quantity and container: 150 gin one glass flask
date of receipt: 19.12.95
storage conditions: at room temperature and protected from light
purity: 99.8%.
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species, strain: rat, Sprague-Dawley ICO: OFA-SD (IOPS Caw).
Reason for choice: rodent species currently required by International Authorities for this type of study.
Breeder: Iffa Credo, 69210 L’Arbresle, France.
Number and sex: one group of 10 animals (5 males and 5 females).
Age/weight: on the day of treatment, the animals were approximately 6 weeks old and had a mean weight of 179 ± 6 g for the males and 152 ± 2 g for the females.
Acclimatisation: at least 5 days before commencement of the study.
Animal identification: the animals were identified individually using perforations or notches in the flap of the ear.
Environment
During the acclimatisation period and during the study, the maintenance conditions of the animal housing facility were as follows:
Temperature: 22 ± 3°C
Humidity: 50 ± 20%
Nyctohemeral period: 12 hrs/12 hrs
Ventilation: around 13 cycles/hour of filtered and non-recycled air.
The temperature and humidity were recorded continuously and the results retained. The accommodation conditions (temperature, humidity, nyctohemeral period and ventilation) were checked each month.
The animals were housed in polycarbonate cages (48 x 27 x 20 cm) fitted with a stainless steel lid. Each cage housed 4 to 7 animals of the same sex for the acclimatisation period and 5 rats of the same sex for the treatment period. Each cage contained sawdust litter made from wood that was screened and had the dust removed (SICSA 94142 Alfortville, France).
Bacteriological analysis of the litter and testing for main contaminants (pesticides, heavy metals) were carried out regularly.
Food and drink
All animals had access to food "Rats and mice maintenance reference A04 C" (U.A.R., 91360 Villemoisson-sur-Orge, France), presented in the form of standardised stoppers.
Each batch of food was analysed (composition and contaminants) by the supplier.
Drinking water, filtered through an F.G. Millipore (0.22 microns), was distributed amongst feeding bottles.
Bacteriological and chemical as well as main contaminants (pesticides, heavy metals and nitrosamines) analyses were carried out regularly.
The non-nutritional substances that may have been present in the food, drinking water or litter were at a level where they were not able to interfere in the good conduct of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The product was administered untouched, taking into account the density of the product d = 1.27.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 10 animals (5 males and 5 females).
- Control animals:
- no
- Details on study design:
- Administration was carried out once, orally, using a tube with a stainless steel eccentric tip (diameter: 18 G.2", Perfektum: Poffer & Sons Inc., New Hyde Park, New York 11040, U.S.A.) mounted on a 1 ml glass syringe (graduations of 0.01 ml, Record: Carrieri, 75005 Paris, France).
The volume administered to each animal was adjusted to the body weight determined on the day of treatment.
CLINICAL EXAMINATIONS
Clinical signs
Observation of the animals was carried out frequently during the hours following administration of the product. It was carried out at least once a day for the 14 days afterwards to note reversible or irreversible clinical signs. The appearance or disappearance of clinical signs was recorded for each animal.
Mortality
The mortality check was carried out frequently just after administration of the product and at least twice a day for a minimum of 14 days of observation.
Body weight
The animals were weighed individually just before administration of the product, then on days 5, 8 and 15.
The weight development of the treated animals was compared to a reference curve drawn up at C.I.T from untreated animals of the same initial weight.
PATHOLOGY
Autopsy
On day 15, the animals were sacrificed using inhalation of an excess of CO2 and underwent a macroscopic examination.
Macroscopic examination
After opening the abdominal and chest cavities, a macroscopic examination of the main organs was carried out: digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and other organs with abnormalities.
The macroscopic observations were recorded individually. The organs presenting macroscopic lesions were sampled and preserved in a formaldehyde buffer at 10%.
Microscopic examination
No microscopic examination was carried out. - Statistics:
- Not specified.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was found during the observation period.
- Clinical signs:
- other: At 2000 mg/kg, signs of hypoactivity or sedation and piloerection were observed in the 4 hours following the treatment. No clinical sign was observed between days 2 and 15.
- Gross pathology:
- There was no proof of a visible abnormality in the macroscopic examination of the main organs of the animals sacrificed at the end of the study.
- Other findings:
- No further findings reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the LD 0 of the product n-BUTYL BROMIDE administered orally in rats is greater than or equal to 2000 mg/kg.
- Executive summary:
At the request of the Sponser, the acute toxicity of the product n-BUTYL BROMIDE was assessed orally in rats in accordance with the O.E.C.D guidelines. (No. 401, 24 February 1987). The study was carried out in accordance with the Good Laboratory Practice regulations.
Methods
The product was administered orally to a group of 10 Sprague-Dawley rats (5 males and 5 females) on a liquid diet. Administration was carried out with the product untouched at a dosage of 2000 mg/kg, taking into account the density of the product d = 1.27.
The clinical signs, mortality and weight development of the animals was monitored for a period of 14 days after single-dose administration of the product.
An anatomical pathological examination was carried out on each of the animals that were sacrificed at the end of the study.
Results
At 2000 mg/kg, a significant reduction in the spontaneous activity and piloerection were observed in the four hours following the treatment. No clinical signs were noted at day 2.
Mortality was zero at a dose of 2000 mg/kg.
The weight development in males was slightly slowed between days 1 and 5. The weight development in females was normal.
The autopsy of the animals that were sacrificed at the end of the study did not show any macroscopic abnormality.
Conclusion
Under the experimental conditions, the LD 0 of the product n-BUTYL BROMIDE administered orally in rats is greater than or equal to 2000 mg/kg.
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