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Diss Factsheets
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EC number: 266-841-2 | CAS number: 67662-96-8
- 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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP study meets generally accepted scientific principles, acceptable for assessment with restrictions: only 8 animals in each test group; no data about the purity and no certificate of analysis of the test substance; no information on the strain, age, sex, body weight, source and housing conditions of the animals; individual animal data was not reported
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Method: Open epicutaneous test
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- open epicutaneous test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- None
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Preliminary test: 100, 30, 10 and 3 % or lower in acetone
Main test:
- Topical induction exposure: 100, 30, 10 and 3 %
- Topical challenge exposures 1 and 2: Minimal irritating (10 %) and lower concentrations - Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Preliminary test: 100, 30, 10 and 3 % or lower in acetone
Main test:
- Topical induction exposure: 100, 30, 10 and 3 %
- Topical challenge exposures 1 and 2: Minimal irritating (10 %) and lower concentrations - No. of animals per dose:
- Eight
- Details on study design:
- PRELIMINARY TEST:
- Estimation of threshold-toxic concentration: One day before starting the induction procedure, 0.025 mL of each test concentration (100, 30, 10 and 3 % or lower in acetone) was applied directly to the clipped flank skin (2 cm2) of the guinea pigs and the skin reactions were observed after 24 h. The minimal irritant and the maximal non-irritant concentrations were determined by an all-or-none criterion.
MAIN STUDY
A. INDUCTION EXPOSURE: EPICUTANEOUS
- No. of exposures: 21
- Test groups: 0.1 mL of each test concentration was applied directly to the skin of animals and the application sites were left uncovered.
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Once daily for 3 weeks
- Evaluation of skin reactions: 24 h after application or at the end of each week
- Duration: Days 0-20
B. CHALLENGE EXPOSURE: EPICUTANEOUS
- No. of exposures: Two
- Day of challenge: Days 21 and 35
- Test groups: 0.025 mL of each test concentration was applied directly to the skin and the application sites were left uncovered.
- Site: Contralateral flank skin (2 cm2)
- Evaluation (h after application): 24, 48 and/or 72 h - Challenge controls:
- On Days 21 and 35, 0.025 mL of each test concentration was applied directly to the skin of vehicle treated or untreated control animals. The application sites were left uncovered and observed for skin reactions after 24, 48 and/or 72 h.
- Positive control substance(s):
- no
- Positive control results:
- Not applicable
- Reading:
- other: challenge 1 on Day 21 (readings at 24, 48 and/or 72 h)
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 3-100 %; challenge: 10 % or lower
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no data
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge 1 on Day 21 (readings at 24, 48 and/or 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 3-100 %; challenge: 10 % or lower. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
- Reading:
- other: challenge 2 on Day 35 (readings at 24, 48 and/or 72 h)
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 3-100 %; challenge: 10 % or lower
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no data
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge 2 on Day 35 (readings at 24, 48 and/or 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 3-100 %; challenge: 10 % or lower. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, LRA 303 “CENTIFOLYL” was considered not to be a skin sensitiser to guinea pig.
- Executive summary:
In an open epicutaneous test (OET), groups of guinea pigs (8/group) were epicutaneously induced with 0.1 mL of the test item, LRA 303 “CENTIFOLYL”, at concentrations of 100, 30, 10 and 3 % in acetone. Each test concentration was applied directly to the clipped flank skin (8 cm2) of guinea pigs, once daily for 21 successive days (Days 0-20) and the application sites were left uncovered. On Days 21 and 35, 0.025 mL of the test item at the minimal irritating (10 %) and some lower concentrations were applied to the contralateral skin of previously treated and untreated or vehicle treated animals.
No skin reactions were noted at the challenge sites of the test group animals on Days 21 and 35. LRA 303 “CENTIFOLYL” produced a 0% (0/8) sensitisation rate and was considered not to be a skin sensitiser to guinea pig.
Under these test conditions, LRA 303 “CENTIFOLYL” was considered not to be a skin sensitiser to guinea pig.
Reference
Preliminary test:
- Lowest irritant concentration: 10 %
- Highest non-irritant concentration: 3 %
Table 7.4.1/1: Main test: skin irritation after repeated applications over 21 successive days
Concentration in % |
Skin irritation after days |
||
7 |
14 |
21 |
|
100 |
very slight |
very slight |
very slight |
30 |
very slight |
very slight |
very slight |
10 |
very slight |
very slight |
very slight |
3 |
none |
none |
none |
Table 7.4.1/2: Main test: capacity to induce allergic sensitisation
Concentration in % (after daily applications over 3 weeks) |
Sensitisation rate |
|
Day 21 |
Day 35 |
|
100 |
0/8 |
0/8 |
30 |
0/8 |
0/8 |
10 |
0/8 |
0/8 |
3 |
0/8 |
0/8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
Pivarose was found to be not sensitising in an OET and FCAT test.
Justification for selection of skin sensitisation endpoint:
Reliable in vivo study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on negative results in two reliable in vivo sensitisation studies, classification under EU DSD or CLP regulations is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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