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EC number: 202-492-4 | CAS number: 96-24-2
- 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:
- 1986-05-06 to 1986-07-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to guideline OECD 406
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-chloropropane-1,2-diol
- EC Number:
- 202-492-4
- EC Name:
- 3-chloropropane-1,2-diol
- Cas Number:
- 96-24-2
- Molecular formula:
- C3H7ClO2
- IUPAC Name:
- 3-chloropropane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): Glycerin-Alpha-Monochlorhydrin
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 8630 M 5/6
- Stability under test conditions: Stable
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan White spotted
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Institut of Biomedical Research, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 419-573g (males) and 428-547g (females)
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding (Lignocel, Schill AG, 4132 Muttenz, Switzerland). Cages were twice weekly cleaned
- Diet: Pelleted standard Kliba 342, Batch 25/86 guinea pig breeding/maintenance diet (Kliba, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: One week under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12:12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% (intradermal, induction) and 100% (topical, induction and challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% (intradermal, induction) and 100% (topical, induction and challenge)
- No. of animals per dose:
- 10 males + 10 females for treatment and 5 males + 5 females for control
- Details on study design:
- RANGE FINDING TESTS: Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea pigs at concentrations of 5, 3, 1 and 0.5% of the test article in pysiological saline. the resulting dermal reactions were assessed 24 hrs later. Additionally patches of filter paper (2x2 cm) were saturated with concentrations of 100, 70, 50 and 25% of test article in physiological saline and applied to the clipped and shaved flank of four guinea pigs. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal + topical)
- Exposure period: 48 hrs (topical)
- Test groups: Test article in physiological saline (intradermal) and pure test article (topical)
- Control group: Physiological saline only
- Site: Scapular region
- Frequency of applications: weekly (d0 = intradermal and day7 = topical)
- Duration: 9 days
- Concentrations: 5% (intradermal) and 100% (topical)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 & 35
- Exposure period: 24 hours
- Test groups: Test article
- Control group: Physiological saline only (first challenge) and Test article (re-challenge)
- Site: Left flank (challenge) and right flank (re-challenge)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- Two challenges were performed each using 5 males + 5 females. In the first challenge physiological saline only was administered topically. In the second challenge control animals were treated with the test article in the same concentration as the animals of the test group (i.e. 100%) in order to avoid false positive results.
- Positive control substance(s):
- yes
- Remarks:
- DNCB, i.e. 1-chloro-2,4-dinitrobenzol
Study design: in vivo (LLNA)
- Statistics:
- Fisher-Test
Results and discussion
- Positive control results:
- After epidermal challenge application, DNCB showed positive responses in Dunkin Hartley albino guinea pigs: after 24 hours 9 (out of 15) guinea pigs were positive.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Any other information on results incl. tables
No positive reactions were evident after the first and second challenge application in the negative control group.
Local symptoms were similar between control and treated animals. Body weight gain was not affected.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- With the procedures used in this experiment, no differences between the test group and the vehicle-treated controls were evident after epidermal challenge application. Glycerin-alpha-monochlorhydrin is considered to possess no skin sensitizing (contact allergenic) potential.
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