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EC number: 436-690-9 | CAS number: 220727-26-4
- 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
Y-15099 was found to be neither irritating to human or rabbit skin nor to the rabbit eye.
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:
- 22 May - 30 Jul 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by the Federal Office of Public Health, 2000
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 90/01) provided by Provimi Klima AG, CH-4303 Kaiseraugst
- Water: Community tap water from Füllinsdorf, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes / hour
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark, music was played during the light period - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- Type of wrap if used: surgical gauze pad (ca. 2.5 cm x 2.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean value of readings at
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean value of readings at
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean value of readings at
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3/3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.
- Executive summary:
The primary skin irritation potential of Y-15099 was investigated in a GLP study according to OECD 404. The shaved left flank of three young adult New Zealand White rabbits was exposed to 0.5 mL undiluted test material for 4 hours under semi-occlusive conditions. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7 days after removal of the dressing.
Well-defined erythema was observed in all animals 1 hour after treatment. Slight to well-defined erythema persisted in one animal up to the 24-hour reading and in the two other animals up to the 72-hour reading. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. No abnormal findings were observed at the test site of any animal on test day 7.
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:
- 26 Jun - 30 Jul 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Federal Office of Public Health, 2000
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: males: 10 - 11 weeks; females: 11 - 12 weeks
- Weight at study initiation: no data
- Housing: individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 90/01) provided by Provimi Kliba AG, CH-4303 Kaiseraugst
- Water: Community tap water from Füllinsdorf, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark, music was played during the light period - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL per animal - Duration of treatment / exposure:
- single eye instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed after instillation
SCORING SYSTEM: Draize system - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean value of readings at
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean value of readings at
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3/3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3/3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3/3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.
- Executive summary:
The primary eye irritation potential of Y-15099 was investigated in a GLP study according to OECD 405. Three young adult New Zealand White rabbits were exposed to the undiluted test item by instillation 0.1 mL into one eye. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application.
The instillation of the test item into the eye resulted in mild, early onset and transient ocular changes in all animals (observation time 1 hour after application). Observations included slight reddening and swelling of the conjunctivae and reddening of the sclera. These effects were reversible and were no longer evident 72 hours after treatment at termination. No abnormal findings were observed in the cornea or iris of any animal at any reading. No staining of the treated eyes by the test item was observed and no evidence of corrosion was evident at any of the measuring intervals. No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The primary skin irritation potential of Y-15099 was investigated in a GLP study according to OECD 404 (Arcelin, 2001). The shaved left flank of three young adult New Zealand White rabbits was exposed to 0.5 mL undiluted liquid test material for 4 hours under semi-occlusive conditions. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7 days after removal of the dressing.
Well-defined erythema was observed in all animals 1 hour after treatment. Slight to well-defined erythema persisted in one animal up to the 24-hour reading and in the two other animals up to the 72-hour reading. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. No abnormal findings were observed at the test site of any animal on test day 7.
In a human volunteer study, the test substance, Y-15099, was evaluated as solution in dried peanut oil and undiluted to determine the highest concentration causing the least irritation to the skin in an 8-day range finding patch study (Dosik, 2002). Twenty subjects were exposed on days 1, 3 and 5 to test substance concentrations of 10, 50 and 100% for 24 hours under semi-occlusive conditions. Treated skin sites were evaluated after each exposure.
The irritation scores for all concentrations were 0.0 in all subjects. There was no difference in irritation potential between the 3 concentrations of the test substance. Based on the results of this study, undiluted Y-15099 did not show irritating potential to human skin.
The primary eye irritation potential of Y-15099 was investigated in a GLP study according to OECD 405 (Arcelin, 2001). Three young adult New Zealand White rabbits were exposed to the undiluted test item by instillation 0.1 mL into one eye. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application.
The instillation of the test item into the eye resulted in mild, early onset and transient ocular changes in all animals (observation time 1 hour after application). Observations included slight reddening and swelling of the conjunctivae and reddening of the sclera. These effects were reversible and were no longer evident 72 hours after treatment at termination. No abnormal findings were observed in the cornea or iris of any animal at any reading. No staining of the treated eyes by the test item was observed and no evidence of corrosion was evident at any of the measuring intervals.
Justification for classification or non-classification
No classification is warranted according to CLP (1272/2008/EC) classification criteria for irritation/corrosion.
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