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EC number: 603-501-8 | CAS number: 13171-18-1
- 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
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2600 (2003) with 20 young adult male Hartley albino Guinea pigs, the test substance was non-irritating and produced no signs of a sensitization response in any of the animals tested. Therefore, the substance was determined to not meet the criteria for classification as a skin sensitizer.
There are no data on which to assess respiratory sensitisation. However, the absence of skin sensitization or reports of respiratory sensitization on related compounds, including Sevofllurane used as a surgical anesthetic, suggest that the potential for this substance to be a respiratory sensitizer is very low.
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:
- 22 August 2017 thru 22 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Sponsor (located outside the EU) performed test to satisfy US EPA new substance requirements based on guidance given by the testing laboratory. At the time the test was initiated, the sponsor had no plans to prepare/submit a REACH registration.
- Specific details on test material used for the study:
- CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing. - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- ANIMALS:
Sex: Male
Age: Young adult
Weight: 319 - 461 grams at experimental start
Source: Received from Hilltop Lab Animals, Inc. on 3 August 2017 and 24 August 2017.
HUSBANDRY:
Stainless steel cages with enrichment (e.g. toy), litter paper changed at least three times per week.
Temp: 19 - 23 deg C and 49 - 75% relative humidity
Room Air Changes/Hour: 12 and 13
Photoperiod: 12-hour light/dark cycle
Acclimitization Period: 7 or 19 days
Food: Envigo Teklad Global Guinea Pig Diet #2040; 20 g/day
Water: Filtered tap ad libitum
IDENTIFICATION:
Each cage was identified with a cage card indicating at least the study number and the ID and sex of the animal.
Each animal was given a unique ID number that was attached via stainless steel ear tag. - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.4 ml
- Day(s)/duration:
- Once (1) per week for three (3) weeks for six (6) hours each.
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% / 0.4 ml
- Day(s)/duration:
- Once (1) for six (6) hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary Irritation Group: 4
Test Group: 20
Naive Control Group: 10 - Details on study design:
- RANGE FINDING TESTS: A preliminary irritation test was peformed on 4 animials to determine the highest non-irritating concentration (HNIC). The HNIC selected for the challenge phase was 100%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals exposed once per week for 3 weeks.
- Control group: 1 group of 10 unexposed animals served as the naive control group.
- Site: left side
- Frequency of applications: Once per week
- Duration: 3 weeks
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27 days after first induction
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals exposed once
- Control group: 1 group of 10 animals
- Site: Right
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after challenge application
- Challenge controls:
- A group of 10 animals, unexposed during the induction phase, served as a naive control group. These control animals were exposed during the challenge phase the same as the test animals.
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
- Positive control results:
- Not applicable.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse findings observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse findings observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse findings observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse findings observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitizer in the Buehler test.
- Executive summary:
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2600 (2003) with 20 young adult male Hartley albino Guinea pigs, the test substance was non-irritating and produced no signs of a sensitization response in any of the animals tested. Therefore, the substance was determined to not meet the criteria for classification as a skin sensitizer.
Reference
No indication of irritation and/or sensitization response following the induction or challenge phase exposures in any animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are no data on which to assess respiratory sensitisation. However, the absence of skin sensitization or reports of respiratory sensitization on related compounds, including Sevofllurane used as a surgical anesthetic, suggest that the potential for this substance to be a respiratory sensitizer is very low.
Justification for classification or non-classification
In an in vivo GLP guideline study conducted according to US EPA Test Guideline OPPTS 870.2600 (2003) with 20 young adult male Hartley albino Guinea pigs, the test substance was non-irritating and produced no signs of a sensitization response in any of the animals tested. Therefore, the substance was determined to not meet the criteria for classification as a skin sensitizer.
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