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EC number: 203-776-0 | CAS number: 110-53-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiences, which do not affect the quality of teh relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- On the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard devition of 2.8 ± 0.4 kg.
Acclimatation: at least 5 days before the beginning of the study.
Identification : individual ear tag.
The conditions in the animal room were set as follows:
- temperature: 18±3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12h/12h
The temperature and relative humidity were under continuous control and recording. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animals were housed individually in polystyrene cages (35 x 55 x 32 cm).
Each cage was equiped with a food container and a water bottle.
All the animals had free access to 110 C pelleted diet.
Food is analysed regularly by the supplier for composition and contaminant levels.
Drinking water filtered by a FG Millipore membrane (0.22 µm) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitroamines).
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left flank of each animal served as control
- Amount / concentration applied:
- Doses of 0.5 ml of the test item were placed on a 6 cm2 dry hydrophilic gauze pad, which then applied to the right flank of the animals.
- Duration of treatment / exposure:
- In first instance, duration of exposure was 4 hours on one flank on a single animal.
Since the test item was no irritant on the first animal, it was then applied for 4 hours to two other animals. - Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
SInce there was persistent irritation reactions at 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progess of the lesions and their irreversibility.
Any change in the animals' behaviour was noted. - Number of animals:
- One in fist instance and 2 for the second run.
- Details on study design:
- The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined in order to check the absence of any signs of skin irritation.
The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
The untreated skin served as control.
Subsequently, the dressings were removed and no residual test substance was oberved.
The animals were then replaced into their individual cages. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 2.7
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3
- Max. score:
- 4
- Other effects:
- From day 4, a dryness of the skin was observed at the treatment site for all 3 animals.
On day 15, a dryness of the skin persisted in 2 animals.
No ulceration or necrosis were noted. - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As the mean scores for erythema, oedema for 2 out of 3 animals reached the criteria values for irritation, under our experimental conditions, n-Pentyl bromide was considered as irritant when administered by cutaneous route in rabbits.
- Executive summary:
The skin irritation potential of the test material was determined according to the OECD 404 guidelines. Three rabbits were exposed to 0.5 ml of the test material for 4 hours, the site was them observed at intervals over a period of 15 days.
The mean scores over 24, 48 and 72 hours for indivudual animals were 3.7, 1.7 and 2.7 for erythema and 2.7, 0 and 2.7 for oedema.
Erytheam and oedema were reversible. From day 4, a dryness of the skin was observed at the treatment site.
The test material was determined to be irritating.
UnderRegulation 1272/2008 the test material should be classed as "Skin Irrit. 2" and assigned the hazard phrase "H315: Causes Irritation to the Skin" and signal word "Warning".
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiences, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- At the start of the study the animals were in the weight range 2.0 to 3.5 kg and were twelve to twenty weeks of age.
After an acclimatization period of at least five days each animal was given a number unique within the study by indelible ink-marking on the inner surface of the ear and the cage label.
The animals were individualy housed in suspended cages.
Free access to mains drinking water and food was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to acheive limits of 17 to 23°C and 30 to 70 % respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchenge was at least fifteen changes per hour and the ligjting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain anay contaminant of a level that might have affected the purpose or integrity of the study. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye served as control
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjonctival sac of the right eye, formed gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hourand 24, 48 and 72 hours following treatment.
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophtalmoscope. - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10.7
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10.7
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation. Minimal conjunctival irritation was noted in one treated eye at the 48-hour observation.
Two treated eyes appeared normal at the 48-hour observation while the remaining treated eye appeared normal at the 72-hour observation. - Other effects:
- All animals showed expected gain in bodyweight during the study.
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 10.7 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Two treated eyes appeared normal at the 48-hour observation while the remaining treated eye appeared normal at the 72-hour observation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The two studies where conducted under GLP and according to OECD 404.
The study giving the greater effect is retained.
Justification for selection of eye irritation endpoint:
The two studies where conducted under GLP and according to OECD 404.
The study giving the greater effect is retained.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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