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EC number: 261-767-7 | CAS number: 59447-55-1
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09/04/2003-17/04/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Perceval Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2-3.5 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-23°C
- Humidity (%):30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light - Type of coverage:
- other: in an elasticated corset
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 3minutes, 1 hour (for 1 rabbit) and 4 hours after application (for all)
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:on the back
- Type of wrap if used: cotton gauze patch, placed in position with a strip or surgical adhesive tape and wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 min, 1 hour, 4 hours
SCORING SYSTEM: Draize
Erythema and Eschar formation: 0-4
Oedema formation: 0-4 - Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 8
- Irritant / corrosive response data:
4 -hour exposure: Very slight erythema and very slight oedema were noted at all treated skin sites one and 24 hours after patch removal. Very slight erythema persisted at one treated skin site at the 48-hour observation. Two treated skin sites appeared normal at the 48-hour observation and one treated skin site appeared normal at the 72-hour observation.
1 -hour exposure: No evidence of skin irritation was noted during the study.
3 -minute exposure period: No evidence of skin irritation was noted during the study.- Other effects:
- /
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 1.0 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC. - Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)
- Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation August 1998 Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Two treated skin sites appeared normal at the 48-hour observation and one treated skin site appeared normal at the 72-hour observation. No corrosive effects were noted. 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no evidence of skin irritation. Conclusion. The test material produced a primary irritation index of 1.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.
Reference
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:
- 29/10/2001-12/11/2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: 1-3.5 kg
- Housing: individually in labelled cages with perforated floors.
- Diet (e.g. ad libitum): +/- 100g per day / hay twice a week
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):21 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 96.7 (95.6-98.6) mg - Duration of treatment / exposure:
- 24hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 2% fluorescein in water + to remove residual test substance, rinsed with approximately 50ml tepid water
- Time after start of exposure: 24 hours
SCORING SYSTEM:Corneal irritation (Opacity: degree of density): 0-4
Iridic irritation: 0-2, Conjunctival irritation: Redness: 0-3, Chemosis: 0-4, Discharge: 0-3
TOOL USED TO ASSESS SCORE: standard lighting or an ophthalmic examination lamp. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- In one animal, corneal injury was seen as opacity (maximum grade 1) and epithelial damage (max. 5% of the corneal area). The opacity had resolved within 48 hours and the epithelial damage within 72 hours.
Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in all animals.
No irridial irritation was observed. - Other effects:
- Corrosion, colouration, toxicity/mortality: no
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelins in Commision Directive 93/21/EEC), FR-1025M does not have to be classified and has no obligatory labelling requirement for eye irritation.
However according to CLP-Regulation (EC) No 1272/2008, FR-1025%M is classified as Irritating to eyes (Category 2) as at least in 2 of 3 tested animals, a positive response of conjunctival redness >=2. - Executive summary:
The study was carried out based on the guidelines described in: EC B5 and OECD 405.
Single samples of approximately 97 mg of FR-1025M were instilled into one eye of each of three rabbits. Two animals were examined 1, 24, 48 and 72 hours and 7 days after instillation. In addition, one animal was examined 1, 24, 48 and 72 hours and 7 days after instillation.
Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae. In one animal, corneal injury was seen as opacity (max grade 1) and epithelial damage (max 5% of the corneal area). The opacity had resolved within 48 hours and the epithelial damage within 72 hours.
Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in all animals.
Remnants of the test substance were present in the eyes of all animals on day 1 and/or day 2.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (93/21/EEC), FR-1025M does not have to be classified and has no obligatory labelling requirement for eye irritation.
Reference
Additional information
Most recent study
Justification for selection of eye irritation endpoint:
Most recent study
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelins in Commision Directive 93/21/EEC), FR-1025M does not have to be classified and has no obligatory labelling requirement for eye irritation. However according to CLP-Regulation (EC) No 1272/2008, FR-1025%M is classified as Irritating to eyes (Category 2) as at least in 2 of 3 tested animals, a positive response of conjunctival redness >=2.
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