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EC number: 251-311-5 | CAS number: 32961-44-7
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970-09-24 - 1971-07-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Usual methods used at the laboratory, as described in the report
- Deviations:
- not specified
- Principles of method if other than guideline:
- The test item was applied as dust or vapour to the test animals
- GLP compliance:
- no
- Remarks:
- study conducted prior to GLP implementation
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- Isobutyl 4-chloro-3,5-diaminobenzoate
- EC Number:
- 251-311-5
- EC Name:
- Isobutyl 4-chloro-3,5-diaminobenzoate
- Cas Number:
- 32961-44-7
- Molecular formula:
- C11H15ClN2O2
- IUPAC Name:
- 2-methylpropyl 3,5-diamino-4-chlorobenzoate
Constituent 1
Test animals
- Species:
- other: rats, rabbits, mice, hamsters
- Strain:
- other: Wistar-II-rats, NMRI mice, Syrian goldhamster, non-pedigree rabbits
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder Winkelmann, Kirchborchen (mice, rats, hamster)
- Females (if applicable) nulliparous and non-pregnant: n/a (only male mice, rats, hamsters used) / not stated for rabbits
- Weight at study initiation: 18-22 g (mice), 160-200 g (rats), 60-80 g (hamsters), 2.5-3.5 kg (rabbits)
Administration / exposure
- Route of administration:
- other: inhalation of either dust or vapour
- Type of inhalation exposure:
- other: nose only (dust) or whole body (dust or vapour)
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dust generator (homogenous dust generation without segregation) or heating of the substance up to 150°C and spreading of the vapour via propeller into exposure chamber
- Exposure chamber volume: 0.2m³ (dust, whole body) or 400l (vapour)
TEST ATMOSPHERE
- Brief description of analytical method used: For dust, the concentration was determined analytically. The test item was solved in methanol and determined spectrophotometically at 335 nm and 1 cm layer thickness. for absorption of the test item from the chamber cotton wool was used. It was possible to dissolve the test item quantitatively.
For vapours, concentration was calculated from the evaporized amount
- Samples taken from breathing zone: generally from exposure chamber - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- for dust atmosphere
- Duration of exposure:
- 4 h
- Remarks on duration:
- 4 hours single dose or 5 * 4 hours repeated dose
- Concentrations:
- 0.024 or 2.30 mg/L (dust, 4h, rats, single dose, nose only)
2.94 mg/L (dust, 5*4h, rats, multiple dose, nose only)
0.975 mg/L (dust, 4h, rabbits, hamsters, mice, single dose, 0.2m³ chamber)
0.726 mg/L (dust, 5*4h, rabbits, hamsters, mice, multiple dose, 0.2m³ chamber)
4.6 mg/L (vapour, 4h, rats, mice, 400L chamber)
7.0 mg/L (vapour, 4h, rabbits, hamsters, 400L chamber) - No. of animals per sex per dose:
- 20 (rats, dust, nose only); 1 (rabbit, dust, 0.2m³ chamber); 5 (hamster, dust, 0.2m³ chamber); 20 (mice, dust, 0.2m³ chamber); 10 (rats, vapour); 20 (mice, vapour); 2 (rabbits, vapour); 5(hamster, vapour)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: signs of toxicity, irritation of mucosa
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Remarks:
- dust, rats, nose only, single exposure
- Effect level:
- > 2.3 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- no signs of toxicity or irritation observed
- Key result
- Sex:
- male
- Dose descriptor:
- LC0
- Remarks:
- dust, rats, nose only, single exposure
- Effect level:
- >= 2.3 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- no signs of toxicity or irritation observed
- Sex:
- male
- Dose descriptor:
- LC50
- Remarks:
- dust, rats, nose only, multiple exposure
- Effect level:
- > 2.94 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 20 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- exposure split into 5*4h; no signs of toxicity or irritation observed
- Key result
- Sex:
- male
- Dose descriptor:
- LC0
- Remarks:
- dust, rats, nose only, multiple exposure
- Effect level:
- >= 2.94 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 20 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- exposure split into 5*4h; no signs of toxicity or irritation observed
- Sex:
- male
- Dose descriptor:
- LC0
- Remarks:
- dust, whole body, rabbit, hamsters, mice, single exposure
- Effect level:
- >= 0.975 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- no signs of toxicity or irritation observed
- Sex:
- male
- Dose descriptor:
- LC0
- Remarks:
- dust, whole body, rabbit, hamsters, mice, multiple exposure
- Effect level:
- >= 0.726 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 20 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- exposure split into 5*4h; no signs of toxicity or irritation observed
- Key result
- Sex:
- male
- Dose descriptor:
- LC0
- Remarks:
- vapour, whole body, rats, mice
- Effect level:
- >= 4.6 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- no signs of toxicity or irritation observed
- Key result
- Sex:
- male
- Dose descriptor:
- LC0
- Remarks:
- vapour, whole body, rabbits, hamsters
- Effect level:
- >= 7 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- no signs of toxicity or irritation observed
- Mortality:
- none observed
- Clinical signs:
- other: no signs of toxicity or irritation were observed
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The study was performed in a scientifically reasonable method with sufficient documentation indicating that the study was well-performed. Hence, there is no doubt that the obtained results are reliable. No mortality was observed. During all experiments, no adverse effects, no signs of toxicity or irritation of mucosa of eyes or nose were observed. Most relevant LC0-values are 2.95 mg/L (rats, dust, over 5*4h) and 7.0 mg/L (rabbits, hamsters, vapour, over 4h) as those are the highest doses tested and also, one including a longer exposure duration. However, as those values are not above the limit values for classification according to Regulation 1272/2008 and no indication of an LC50 is given, the study cannot be used for classification, may however give the indication that the substance is not highly toxic by inhalation.
- Executive summary:
The test item was applied both as dust and vapour to four species at the following concentrations and conditions:
0.024 or 2.30 mg/L (dust, 4h, rats, single dose, nose only)
2.94 mg/L (dust, 5*4h, rats, multiple dose, nose only)
0.975 mg/L (dust, 4h, rabbits, hamsters, mice, single dose, 0.2m³ chamber)
0.726 mg/L (dust, 5*4h, rabbits, hamsters, mice, multiple dose, 0.2m³ chamber)
4.6 mg/L (vapour, 4h, rats, mice, 400L chamber)
7.0 mg/L (vapour, 4h, rabbits, hamsters, 400L chamber)
Acute and subacute toxicity by inhalation of both dust and vapours is very low, the highest determined LC0 values are 2.95 mg/L (rats, dust, over 5*4h) and 7.0 mg/L (rabbits, hamsters, vapour, over 4h).
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