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EC number: 924-149-4 | CAS number: 125109-84-4
- 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 study: Bremer (1988), OECD 401: LD50 >2000 mg/kg bw in males/females
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 16th March 1988 to 26th April 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A GLP compliant study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The read-across is considered to be suitable based on the structural and 'mechanistic action' similarities between the target substance (3-(3-isopropenylphenyl)butanal) and source substance (3-(3-isopropylphenyl)butanal) and their similar physico-chemical properties.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Fü-albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 5-6 weeks old
- Weight at study initiation: males: 107.3-130.6 g; females: 111.7-118.7 g
- Fasting period before study: approximately 18 hours
- Diet: NAFAG standard rat maintenance diet, No. 850 ad libitum
- Water: tap water ad libitum
- Acclimation period: seven days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 24th March 1988 To: 8th April 1988 - Route of administration:
- oral: gavage
- Vehicle:
- other: Standard Suspending Vehicle (SSV)
- Details on oral exposure:
- VEHICLE
- Standard Suspending Vehicle contains 5 g sodium carboxy methyl cellulose; 4 mL Tween 80; 5 mL benzylalcohol; 9 g sodium chloride; made up to 1000 mL in distilled water.
MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: daily (behaviour, vivacity, signs of injury, signs of sickness and abnormality); days 0, 4, 7, 12 and 15 (body weight)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, behaviour, body weight. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No incompatability reactions appeared.
- Gross pathology:
- No autopsy findings were seen.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the acute oral toxicity of the test material in rats was determined to be >2000 mg/kg. A single administration of the test material had no impact on the body weights of the test animals.
- Executive summary:
Five male and five female Fü-albino rats (males: 107-131 g, females: 112 -119 g; about 5-6 weeks old) were randomly selected for an acute oral toxicity study. fasted rats were given a single dose of the test material suspended in Standard Suspending Vehicle (SSV) by gavage at a dose level of 2000 mg/kg bw. They were observed for 15 days for toxic signs including mortality and body weight changes. All rats were examined for gross lesions.
The acute oral toxicity of the test material in rats was determined to be greater than 2000 mg/kg, No deaths occurred. No incompatibility reactions were observed, No effects on the body weight development appeared. No autopsy findings were seen.
Reference
ANALOGUE APPROACH JUSTIFICATION:
- See “Justification for read-across” document attached in section 13 for full details.
- In summary, important considerations for the use of read-across for acute toxicity are: i) 3-(3-isopropenylphenyl)butanal (the target substance) has similar physico-chemical properties as 3-(3-isopropylphenyl)butanal (the source substance), ii) there are structural similarities between the two substances, iii) the OECD QSAR Toolbox assigns very similar toxicity profiles to both substances, with any differences indicating that the source substance may be representative of a worst case scenario. The information reported in this summary is included to demonstrate comparability between the source (3-(3-isopropylphenyl)butanal) and target substance (3-(3-isopropenylphenyl)butanal).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- One study available with a Klimisch score of 2 which was assigned on the basis of read-across. The quality of the database is therefore high.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Five male and five female Fü-albino rats (males: 107-131 g, females: 112 -119 g; about 5-6 weeks old) were randomly selected for an acute oral toxicity study. fasted rats were given a single dose of the test material suspended in Standard Suspending Vehicle (SSV) by gavage at a dose level of 2000 mg/kg bw. They were observed for 15 days for toxic signs including mortality and body weight changes. All rats were examined for gross lesions.
The acute oral toxicity of the test material in rats was determined to be greater than 2000 mg/kg, No deaths occurred. No incompatibility reactions were observed, No effects on the body weight development appeared. No autopsy findings were seen.
The read-across is considered to be suitable based on the structural and 'mechanistic action' similarities between the target substance (3-(3-isopropenylphenyl)butanal) and source substance (3-(3-isopropylphenyl)butanal) and their similar physico-chemical and toxicological properties.
Justification for selection of acute toxicity – oral endpoint
Only one key study is available
Justification for classification or non-classification
According to Regulation 1272/2008 and Directive 67/548/EEC, the substance does not require classification for acute oral toxicity.
On the basis that the test material for the acute oral toxicity study (3-(3-isopropylphenyl)butanal, tradename Florhydral) is being used to support 3-(3-isopropenylphenyl)butanal (Dehydro Florhydral) on the basis of read-across, Dehydro Florhydral is also considered to be unclassified for acute oral toxicity.
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