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EC number: 448-060-0 | CAS number: 727678-39-9
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Aug to 12 Sept 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study without restrictions.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Japanese Test Guidelines
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: approximately 4 weeks
- Weight at study initiation: 310 - 364 g
- Housing: Maximal 5 animals were group housed in metal cages (57 cm x 41 cm x 23 cm height) with wire-mesh floors or in cages (74 cm x 54 cm x 25 cm height) with purified sawdust as bedding material.
- Diet: Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, ad libitum and pressed hay twice a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 - 22.7
- Humidity (%): 45 - 89
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil, Freund's Complete Adjuvant (FCA)
- Concentration / amount:
- Intradermal induction: 2%
Topical induction: 50%
Challenge: 50% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil, Freund's Complete Adjuvant (FCA)
- Concentration / amount:
- Intradermal induction: 2%
Topical induction: 50%
Challenge: 50% - No. of animals per dose:
- 5 irritation control animals, 10 animals in test group, 4 animals for the preliminary irritation study
- Details on study design:
- RANGE FINDING TESTS:
To find an appropriate concentration for intradermal induction, the maximum concentration that could technically be injected and three lower concentrations of the test substance in corn oil were injected into the scapular region of two guinea pigs. Each of these guinea pigs received 0.1 mL of two different concentrations (2 and 5% or 10 and 20%, respectively) in duplicate. At 24 and 48 h post injection, 10 and 20% of the test substance caused well defined erythema, whereas 2 and 5% of the test substance lead to slight erythema formation. However, the injection of 5, 10 and 20% of the test substance was difficult and the reliability of the injected volume could not be established. Because 2% of the test substance in corn oil was considered the highest concentration that could reproducibly be injected this concentration was used in the main study for the intradermal induction.
The two guinea pigs used for the testing of intradermal irritation and two additional animals were epicutaneously treated on one flank with 0.5 mL of 20 and 50% or 5 and 10% of the test substance, respectively, to provoke a slight irritative effect. No irritation was observed at any concentration level. Because a concentration of 50% test substance was the maximum concentration that could technically be applied, this concentration was used in the main study for epicutaneous induction and challenge. To provoke a mild inflammatory reaction, the scapular treatment site was rubbed with 10% sodium dodecyl sulfate (SDS) in vaseline, the day before the epicutaneous induction.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one epicutaneous treatment, respectively
- Exposure period: single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections)
Injection 1: 0.1 mL of a 1:1 mixture (w/w) of FCA (Difco, Detroit, USA) and water for injection (Fresenius AG, Bad Homburg, Germany)
Injection 2: 0.1 mL of 2% (w/w) test substance in corn oil
Injection 3: 0.1 mL of a 1:1 mixture (w/w) of 4% test substance in corn oil and FCA
Epicutaneous: 0.5 mL of 50% test substance in corn oil
The day before the epicutaneous induction, the scapular treatment site was rubbed with 10% SDS in vaseline, to provoke a mild inflammatory reaction.
- Control group:
Intradermal (3 pairs of injections)
Injection 1: 0.1 mL of a 1:1 mixture (w/w) of FCA (Difco, Detroit, USA) and water for injection (Fresenius AG, Bad Homburg, Germany)
Injection 2: 0.1 mL of corn oil
Injection 3: 0.1 mL of a 1:1 mixture (w/w) of corn oil and FCA
Epicutaneous: 0.5 mL of corn oil
The day before the epicutaneous induction, the scapular treatment site was rubbed with 10% SDS in vaseline, to provoke a mild inflammatory reaction.
- Site: scapular region (intradermal and epicutaneous)
- Frequency of applications: intradermal injection on Day 1 and epicutaneous application on Day 8
- Duration: single intradermal injections; epicutaneous treatment for 48 h
- Concentrations: intradermal 2%, epicutaneous 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24 h
- Test groups: 0.1 mL of the test substance in corn oil and 0.1 mL corn oil
- Control group: 0.1 mL of the test substance in corn oil and 0.1 mL corn oil
- Site: one flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- historical positive control: 20% alpha-Hexylcinnamicaldehyde (Tech., 85%) in water
- Positive control results:
- The procedures used in this study were validated using the positive control substance alpha-Hexylcinnamicaldehyde. The most recent validation of the test system was performed between May and June 2003. The positive control substance induced positive reactions in 6/10 animals (60%) thus meeting the reliability criteria for the guinea pig maximization test (≥ 30%).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Induction: 0%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 2% and 50%; Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction: 2% and 50%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 20% and 100%; Challenge: 20%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Induction: 20% and 100%; Challenge: 20%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction: 0%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 2% and 50%; Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction: 2% and 50%; Challenge: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 20% and 100%; Challenge: 20%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Induction: 20% and 100%; Challenge: 20%. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Results of the challenge phase
The challenge treatment with 50% of the test substance or the vehicle did neither in the test substance group nor in the negative control group result in any erythema or edema at the 24 and 48 h reading time points.
Results of the induction phase
The intradermal injections of 0.1 mL of FCA (50% (w/w)) caused well-defined to moderate erythema in the test and control group. The test substance (2% (w/w)) and a 1:1 mixture of the test substance with FCA caused slight to moderate erythema in the test group. In the control group, the intradermal injection of 0.1 mL of the vehicle or a 1:1 mixture of the vehicle and FCA leads to slight to well-defined erythema.
After the epicutaneous treatment of the test group with 50% of the test substance, no erythema or edema formation was observed in any animal.
Clinical observations
No mortality occurred and no symptoms of systemic toxicity were observed during the study period. There was no difference in body weight and body weight gain between the test group and the negative control.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
UY-330 was examined in a Guinea Pig Maximisation Test according to OECD 406 and GLP (Hooiveld, 2003). After the intradermal induction with 2% of the test substance, slight to moderate erythema were observed in the test group. In the negative control group, the intradermal injection of the vehicle led to slight to well-defined erythema. The epicutaneous induction with 50% test substance in corn oil or the vehicle alone had no irritating effect in the test and control groups, respectively, although the treated skin site was 24 h before pre-treated with 10% SDS.
At challenge, neither the test group nor the control group showed any skin reactions. The positive control animals, treated with 20% alpha-Hexylcinnamicaldehyde, showed positive reactions at the first (6/10) and the second reading (5/10).
Under the test conditions, the test substance was not considered to be a skin sensitiser.
Migrated from Short description of key information:
Skin (Guinea pig maximisation test, OECD 406): not sensitising
Justification for selection of skin sensitisation endpoint:
Only one study is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.
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