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EC number: 700-957-0 | CAS number: 1141852-17-6
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
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:
- 14 - 26 Apr 2010
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 20 weeks (male) and 10-13 weeks (females)
- Weight at study initiation: 3815 g (male) and 2290-2314 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Apr 2010 (one female) or 21 Apr 2010 (the male and the second female) To: 26 Apr 2010 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 6 (one male and one female) or 7 days (one female)
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the left flank
- Type of wrap if used: the test substance was placed on a surgical gauze patch, which was held in contact with the skin by means of an adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008, B.4, Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. The individual mean erythema/eschar and edema score for each of the three animals was therefore 0. No staining and no corrosive effects were observed on the treated skin.
- Other effects:
- No further local or systemic effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vivo study, performed according to OECD/EC guidelines, Y-15866 is concluded not to have adverse effects on the skin.
- Executive summary:
The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404. The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores over 24, 48 and 72 h were 0 for all 3 animals.
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 Apr - 07 May 2010
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 22 weeks (male) and 12-15 weeks (females)
- Weight at study initiation: 4025 g (male) and 2618-2680 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03 May 2010 (one female) or 04 May 2010 (the male and the second female) To: 07 May 2010 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 5 (one male and one female) or 6 days (one female)
reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight reddening of the conjunctivae was noted in all animals 1 h after instillation and persisted in one female at the 24 h reading. Slight reddening of the sclerae was noted in the male and one female at the 1 h reading. At the same observation point, slight swelling of the conjunctivae was also present in this female. No abnormal findings were observed in the cornea or for the iris light reflex. No corrosion and no staining were observed in the treated eyes.
- Other effects:
- No further local or systemic effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an in vivo study, performed according to OECD/EC guidelines, Y-15866 is concluded not to have adverse effects on the eye.
- Executive summary:
The eye irritation potential of Y-15866 was investigated in a study according to OECD guideline 405 and in compliance with GLP. The undiluted test substance (0.1 mL) was placed into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. The instillation of Y-15866 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, as well as chemosis. These effects were reversible and were no longer evident up to 48 h after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion and no staining of the treated eyes and no clinical signs were observed. The individual mean scores after 24, 48 and 72 h for corneal opacity and iris light reflex were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for chemosis for all 3 animals.
Reference
Table 1. Results of eye irritation study (individual scores)
Rabbit # |
Time [h] |
conjunctivae |
iris |
cornea |
|
redness |
chemosis |
||||
1 |
1 |
1 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
2 |
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
0 |
0 |
0 |
|
3 |
1 |
1 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404 (Arcelin, 2011). The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores after 24, 48 and 72 h were 0 for all 3 animals.
Eye irritation
The eye irritation potential of Y-15866 was investigated in a study according to OECD guideline 405 and in compliance with GLP (Arcelin, 2010). The undiluted test substance (0.1 mL) was placed into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. The instillation of Y-15866 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, as well as chemosis. These effects were reversible and were no longer evident up to 48 h after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animal at any of the examinations. No corrosion and no staining of the treated eyes and no clinical signs were observed. The individual mean scores for corneal opacity and iris light reflex after 24, 48 and 72 h were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for chemosis for all 3 animals.
Justification for classification or non-classification
The available data on skin and eye irritation of Y-15866 do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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