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Diss Factsheets
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EC number: 619-880-8 | CAS number: 176972-62-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- March 20, to May 18, 1955
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and was designed to meet OECD guideline 405 for assessing acute ocular irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Chlorohydrine
- IUPAC Name:
- Chlorohydrine
- Reference substance name:
- (1S,2S)-(1-Benzyl-3-chloro-2-hydroxy-propyl)-carbamic acid methyl ester
- IUPAC Name:
- (1S,2S)-(1-Benzyl-3-chloro-2-hydroxy-propyl)-carbamic acid methyl ester
- Details on test material:
- Chemical Name: (1S,2S)-(1-Benzyl-3-chloro-2-hydroxy-propyl)-carbamic acid methyl ester
Physical State: Solid
Source: Syntex Group Technology Center, Boulder, Colorado
Storage: Room temperature
GLP Status: GLP
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye served as an untreated control
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to7 days after treatment
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
- Other effects:
- Results:
Slight conjunctival chemosis and/or iridial changes were observed in all rabbits 1 hour postdosing. Slight to moderate conjunctival redness, chemosis, and iridial changes were seen in 2 rabbits 24 hours postdosing. Seventy-two hours postdosing, iridial changes were no longer observed. All rabbits were normal 7 days postdosing.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Although Ro 61-4022 caused slight reversible irritation to the eye, it is not considered an ocular irritant under the test conditions and under EU and OECD criteria and thus, no labeling for eye irritation potential is required under EU regulatory criteria.
- Executive summary:
Purpose: The Environmental Health and Safety Division have requested that safety evaluation studies be performed with Chlorohydrine. The study was conducted according to GLP and was designed to meet OECD guideline 405 for assessing acute ocular irritation.
Unless otherwise stated, all procedures were conducted according to Syntex Standard Operating Procedures. No unforeseen circumstances affected the quality or the integrity of the study. The raw data and report for this study are maintained in Syntex archives managed from 3401 Hillview Avenue, Palo Alto, California.
Study Design: Three male rabbits each received a single dose of 0.1 g of Chlorohydrine that was placed into the conjunctival sac of the right eye of each rabbit. The left eye served as an untreated control. Following the 24-hour postdosing eye examination, both eyes of each rabbit were rinsed with an isotonic saline solution. The eyes were examined for signs of irritation approximately 1, 24, 48, and 72 hours; and 7 days after treatment, and scored according to a modification of the Draize method at these time periods.
Results: Slight conjunctival chemosis and/or iridial changes were observed in all rabbits 1 hour postdosing. Slight to moderate conjunctival redness, chemosis, and iridial changes were seen in 2 rabbits 24 hours postdosing. Seventy-two hours postdosing, iridial changes were no longer observed. All rabbits were normal 7 days postdosing.
Conclusion: Although Ro 61-4022 caused slight reversible irritation to the eye, it is not considered an ocular irritant under the test conditions and under EU and OECD criteria and thus, no labeling for eye irritation potential is required under EU regulatory criteria.
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