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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Apr - 30 Jul 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by the Federal Office of Public Health, 2000
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was completed in 2001 and was the standard skin sensitisation study at the time.
Test material
- Details on test material:
- - Name of test material (as cited in study report): Y-15099
- Physical state: pale yellow liquid
- Analytical purity: 99.6%
- Lot/batch No.: 18161-74
- Expiration date of the lot/batch: 2002-10-23
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: In the original container, at room temperature (range of 20 ± 3 °C), away from direct sunlight. Store under nitrogen. Avoid contact with moisture.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Füllinsdorf, Switzerland
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 316 - 396 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). Music was played during the light period.
- Diet: Pelleted standard Provimi Kliba 3418, batch nos. 33/00 and 90/01, guinea pig breeding / maintance diet, containing Vitamin C (Provimi Kliba AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °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.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (for all induction and challenge treatments)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% (for all induction and challenge treatments)
- No. of animals per dose:
- 10 animals for the test group and 5 animals for the control group
- Details on study design:
- RANGE FINDING TESTS:
The 100% concentration of the test item used for the intradermal application was well-tolerated systemically, causing mild skin irritation during the pretest. Epidermal application of the undiluted substance in the pretest did not cause any skin irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections (day 1) and 1 epidermal application (day 8) for 48 hours
- Test groups: TS and FCA
- Control group: Peanut oil and FCA
- Site: dorsal skin of the scapular region
- Duration: 48 hours for epidermal induction under occlusive dressing
- Concentrations: 100% for injections as well as for epidermal application
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: Day 22
- Exposure period: 24 hours under occlusive dressing
- Test groups: TS
- Control group: TS
- Site: 3 x 3 cm area of the left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the bandage - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- A reliability check had been performed with 2-mercaptobenzothiazole half a year before in the same laboratory, confirming the sensitivity of the used animal strain.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% in mineral oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% in mineral oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the findings in the adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 96/54/EEC, Y-15099 has to be classified and labelled as an extreme skin sensitizer.
- Executive summary:
In order to assess the cutaneous allergenic potential of Y-15099, the Maximization-Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of sensitization in the test group was performed in the nuchal region with the undiluted test item (100%). The epidermal induction of sensitization was conducted for 48 hours under occlusive conditions with the undiluted test item one week after the intradermal induction and following pre-treatment of the test areas with 10% Sodium-Lauryl-Sulfate (SLS) 24 hours prior to application of the test item. The animals of the control group were treated with 10% SLS only.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the undiluted test item under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred.
Eight (at the 24 -hour reading) and 9 (at the 48 -hour reading) out of 10 test animals showed discrete/patchy to moderate/confluent erythema after the challenge treatment with Y-15099 at 100%. No skin effect was observed in the control group.
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