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EC number: 200-860-9 | CAS number: 75-31-0
- 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
Isopropylamine gave no evidence of a skin-sensitising potential in the guinea-pig maximisation assay
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct./Nov. 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA test has been performed as a reliable non-LLNA skin sensitising assay has already been available.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre dÉlevage Lebeau, France
- Age at study initiation: no data
- Weight at study initiation: 432 +-34 g (m); 440 +-22 g) (f)
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >=5 d before start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1
- Humidity (%): 50 +-20
- Air changes (per hr): no technically forced exchange
- Photoperiod (hrs dark / hrs light): 12 / 12
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.1 mL of a 0.1 % dilution in aqueous isotonic saline on day 1 of study
epicutaneous induction: 0.5 mL of 1 % dilution in aqueous isotonic saline on day 8 of study
10 % = maximum non-irritant concentration (epicutaneous challenge) - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 mL of the Maximum Non Irritant Concentration (10 %) on day 22 of study
- No. of animals per dose:
- 5 m + 5 f (pos. and neg. control groups); 10 m + 10 f (test group)
- Details on study design:
- RANGE FINDING TESTS:
Minimum Irritant Concentration for id and epicutaneous application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2x (day 1 and 8)
- Exposure period: 48 h (dermal) following 24h treatment with 0.5 mL 10% laurylsulphate
- Test groups: FCA/saline, FCA + 0.1% TS/saline, 0.1% TS/saline (intradermal); 0.5 mL 1% TS/saline (dermal)
- Control group: FCA/saline, FCA/saline + saline, saline (intradermal); 0.5 mL saline (dermal)
- Site: scapular region
- Frequency of applications: 1x (id), 1x (dermal)
- Duration: 8 d
- Concentrations: 0.1 % (id), 1 % (dermal)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (dermal)
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups:
- Control group:
- Site: right flank (TS) / left flank (saline)
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48 h
C. OTHER
Clinical observation,
body-weight control until day 25
Necropsy on day 25 - Positive control substance(s):
- yes
- Remarks:
- dinitro 2,4-chlorobenzene
- Positive control results:
- Challenge with 0.1 % DNCB: erythema scores 2 for 4/5 animals, score 1 for 1/5 animals (reading 24 h p.a.)
Challenge with 0.5 % DNCB: erythema scores 4 for 2/5 animals, score 3 for 3/5 animals (reading 24 h p.a.) - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Dose level:
- 0.5 % dinitro 2.4 chlorobenzene
- Total no. in group:
- 5
- Clinical observations:
- positive skin sensitization reactions in 100% of the guinea-pigs
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance was not sensitising
- Executive summary:
A guinea pig maximisation test was performed according to OECD guideline 406 with 5 animals per sex in the control group and 10 per sex in the treatment group. Intradermal induction was performed on day 1 of study with 0.1 mL of 0.1 % dilution of the test substance in the vehicle isotonic saline. On day 8, epicutaneous induction was done with 0.5 mL of 1 % test substance dilution. Challenge occured at day 22 of study with 0.5 mL of a 10 % test substance in vehicle for 24 h. Cutaneous reactions were scored 24 and 48 h after the end of this treatment. No clinical signs or deaths were observed, and no cutaneous reactions occured.
The positive control DNCB showed positive results in this test system.
Under the conditions of this study, the test substance was considered to be non-senstising.
Reference
Pre-Test
intradermal: 0.1 % were irritant, 1 % necrotic after 24 h post-application
dermal: 10 % not irritant after 24 h post-application, 25 % were necrotic.
Main test
No clinical signs, no mortalities, normal body-weight gain.
After induction, irritation in the control group and necrosis in treated group were observed.
No cutaneous reaction (scores 0) was observed at 24 and 48 h after dermal challenge at the maximum mon-irritant concentration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Isopropylamine was not sensitizing in a guinea pig maximization test in which Dunkin-Hartley guinea pigs (10/sex) were induced by intradermal injection (0.1 %) followed by an epicutaneous patch exposure (1.0 %) and then challenged 2 weeks later with a 10 % solution. None of the test or control animals had a positive reaction after evaluations at 24 and 48 hours post-challenge (Elf Atochem, 1994).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Neither the results of a sensory irritation study using mice (Gagnaire, 1989) nor the results of a 90 -day rat inhalation study (Monsanto, 1988) indicate a sensitizing potential. Further, no signs of skin sensitisation were seen in guinea pigs (Elf Atochem, 1994).
Moreover, an experimental study is not necessary due to the corrosive character of the submission substance.
Justification for classification or non-classification
Based on the negative findings in in vivo studies it is concluded that isopropylamine has not to be classified as skin sensitising according to Regulation (EC) No 1272/2008. No information on respiratory sensitisation is available.
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