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EC number: 931-320-7 | CAS number: 195262-41-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 November 1997 to 21 December 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (challenge concentration was not non-irritating)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Alcohols, C16-19-branched
- EC Number:
- 297-790-4
- EC Name:
- Alcohols, C16-19-branched
- Cas Number:
- 93762-74-4
- IUPAC Name:
- 93762-74-4
- Reference substance name:
- Alcohols, C16-C19 branched
- IUPAC Name:
- Alcohols, C16-C19 branched
- Details on test material:
- - Name of test material (as cited in study report): Development Detergent Alcohol 23731-52
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: alcohols, C16-C19 branched
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 23731-52
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: original container at room temperature and under nitrogen
- Other:
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: 325-366 g at randomization
- Housing: individual, suspended wire-mesh cages
- Diet: PMI Feeds, Inc. Certified Guinea Pig LabDiet 5026, ad libitum
- Water: reverse osmosis-treated municipal water, ad libitum
- Acclimation period: a minimum of 5 days prior to initiation of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 35.0-45.8
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: PEG 400 or 1:1 FCA and sterile saline
- Concentration / amount:
- Induction phase: 5% w/v mixture in PEG 400 or 1:1 FCA and sterile saline prepared for injection, neat material used for occlusive epicutaneous induction phase
Challenge phase: 2.5% w/v mixutre in PEG 400
Rechallenge phase: 0.5% w/v mixture in PEG 400
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: PEG 400 or 1:1 FCA and sterile saline
- Concentration / amount:
- Induction phase: 5% w/v mixture in PEG 400 or 1:1 FCA and sterile saline prepared for injection, neat material used for occlusive epicutaneous induction phase
Challenge phase: 2.5% w/v mixutre in PEG 400
Rechallenge phase: 0.5% w/v mixture in PEG 400
- No. of animals per dose:
- 10 (controls), 20 (test group)
12 (range finding study) - Details on study design:
- RANGE FINDING TESTS: Intradermal and topical range finding studies conducted. Guinea pigs received a total of six 0.1 ml intradermal injections in a 2 x 4 cm area on the dorsal surface. Three pairs of injections were made along the spine of each guinea pig. Each animal received one injection of 1, 3 or 5% w/v concentrations of the test material in PEG 400 and in a 1:1 FCA and sterile saline solution. For the topical range finding test, 2.5, 5, 10, 25 or 50% w/v mixtures in PEG 400, as well as the neat material, were used and administered at 0.2 ml/site under occulded chambers for 24 h. There were 3 sites/guinea pig and 4 sites/concentration. After a 24-h exposure period, the bandages were removed and the sites washed with disposable paper towels moistened with tepid tap water. The guinea pigs were observed twice daily for mortality and the application sites were evaluated at approx. 24 and 48 h after intradermal injection or patch removal and graded accordingly (see "any other information" section below). The hair was removed from the backs of the guinea pigs prior to evaluation
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 9 days
- Test groups: Test material in PEG 400 or a 1:1 mixture of FCA and sterile saline for the injection phase, neat test material for the topical phase
- Control group: PEG 400, 1:1 mixture of FCA and sterile saline, 50% w/v concentration of PEG 400 in 1:1 mixture of FCA and sterile saline
- Site: dorsal surface
- Frequency of applications: one intradermal injection exposure on day 0 and one topical exposure on day 7
- Duration: 9 days
- Concentrations: intradermal injection of 5% test material, topical application of neat test material
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 & 29
- Exposure period: 24 hours
- Test groups: test material in PEG 400 and PEG 400
- Control group: test material in PEG 400 and PEG 400
- Site: test material in PEG 400 - left flank; PEG 400 vehicle only - right flank
- Concentrations: 0.5 or 2.5%
- Evaluation (hr after challenge): 24 & 48 hours
OTHER: Sites were washed with disposable paper towels moistened with tepid water after each challenge exposure period - Challenge controls:
- Control group subjected to the same induction procedure as test group but without test material; control and test groups both challenged with test material in the same way
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde (see "Any other information" section below)
Study design: in vivo (LLNA)
- Statistics:
- Not required
Results and discussion
- Positive control results:
- At challenge, the positive control material induced 3 very slight (grade +/-), 4 slight (grade 1) and 3 moderate (grade 2) reactions at the 24 h evaluation. By 48 h, 3 very slight, 5 slight and 2 moderate responses were observed. Focal eschar was noted for one site at both 24 and 48 h. The Sensitization Incidence Index was calculated to be 70% for the positive control and the Irritation Severity Indices were 1.2 and 1.1 at 24 and 48 h respectively. The positive control material was, therefore, shown to be a sensitizer under the conditions of the study, thereby demonstrating the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 14 grade 1, 4 grade 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: 14 grade 1, 4 grade 2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- grade 1
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: grade 1.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- grade 1
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: grade 1.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- grade 1
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: grade 1.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5% HCA
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5% HCA. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5% HCA
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5% HCA. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 8 grade 1, 2 grade 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 8 grade 1, 2 grade 2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- grade 1
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: grade 1.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- grade 1
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: grade 1.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no irritation reactions
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no irritation reactions.
Any other information on results incl. tables
Since the reactions in the test group were no more intense than the response to the test material in the negative control group, the test material is not considered to be a skin sensitiser in this study. The sensitivity of the test system was demonstrated by a clear positive response to the positive control.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a reliable study, conducted to OECD guideline 406, there was no evidence of skin sensitisation in a guinea pig maximization test, under the conditions of this study. The study was performed in compliance with GLP.
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