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EC number: 225-035-0 | CAS number: 4621-04-9
- 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
The primary irritation test (IFF, 1984) and the contact-sensitizing test (RIFM, 1975) both indicate no irritation. Therefore the substance is not classified for skin irritation under GHS guidance.
The primary irritation test (IFF, 1984) indicates eye irritation. The substance is classified for eye irritation under GHS guidance. Not fully reversible within 7 days, hence classified as Cat.2A.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- April 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human Maximization Test
- GLP compliance:
- no
- Species:
- other: Humans
- Type of coverage:
- other: Closed patch test
- Preparation of test site:
- not specified
- Amount / concentration applied:
- 5% Folrosia in aqueous sodium lauryl sulfate
- Duration of treatment / exposure:
- 48h
- Observation period:
- 48hr, 72hr
- Number of animals:
- 25 human subjects completed the study.
- Details on study design:
- Human patch test.
- Irritation parameter:
- other: Observation of contact-sensitization
- Basis:
- mean
- Time point:
- other: 48hr/72hr
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Executive summary:
There were no instances of contact-sensitization from Folrosia on the Maximization Test and no incidences of skin irritation.
Therefore it is concluded that it is unlikely that Folrosia would present a danger of contact-sensitizastion in normal, intended use.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 30 August, 1983 - 02 September, 1983
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Well described short report. Dose, number of animals (with details), experimental design and observation period are described in the study. Performed in compliance with the FDA's GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pine Acres Rabbitry, W. Brattleboro, VT
- Age at study initiation: 11 to 15 weeks
- Weight at study initiation: 2.5 to 3.0 kg
- Housing: No data
- Diet: Agway Prolab Rabbit formula, lot # W1 32189
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
No data - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated site on the left side of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Dermal reactions were scored 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
Approximately 24 hours prior to treatment, the fur on the sides of each animal was closely clipped with care taken not to abrade the skin. The test substance was introduced under a 1"x1" gauze pad previously secured to the test site with surgical tape. Four pads were employed, each one for a separate sample. Two different test substance pads were placed on the left side, and two more different test sample pads were placed on the right side. A 1"x1" gauze pad was applied to an untreated site on the left side of each animal to serve as control. The animals were then wrapped with an impervious covering (plastic wrap) and then stockinette to prevent removal of the patches by the animal.
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1, #2, #3, #4, #5 and #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No erythema or edema was observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal irritation study with male rabbits performed equivalent to OECD 404 guideline and GLP principles, no erythema or edema was observed.
- Executive summary:
Folrosia, sample 83 -223 -02, was tested in an acute dermal irritation study with male rabbits, performed equivalent to OECD 404 guideline and GLP principles. No erythema or edema was observed.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In vivo eye irritation method. Dose selections made according to the EPA Health Effect Test Guideline.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Albino New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- 21 days
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1hr
- Score:
- 35.9
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 25.5
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 26.1
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 36
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 19.2
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 2
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 14
- Max. score:
- 110
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Not fully reversible within 7 days, hence classified as Cat.2A.
- Executive summary:
Based on the results of this study, Folrosia is classified as moderately irritating to the Rabbit Eye.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.