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EC number: 262-679-1 | CAS number: 61260-55-7
- 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:
- 04 Jan - 19 Feb 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted February, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, 4799 Borchen
- Age at study initiation: adult animals
- Weight at study initiation: 358 - 362 g
- Diet (ad libitum): Ssniff G 4 - Alleindiät for guinea pigs, Firma Ssniff, Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water, Fa. Gelsenwasser, Wasserwerk, 4358 Haltern
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0% (Induction and Challenge), 10.0% (Preliminary and Induction))
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0% (Induction and Challenge), 10.0% (Preliminary and Induction))
- No. of animals per dose:
- Preliminary study: 4
Main study: 20
Control group for main study: 10 - Details on study design:
- RANGE FINDING TESTS:
In the preliminary test, a concentration of 10.0% of the test substance in vaseline had no primary irritant effect. Therefore, for the induction phases I, II and III, and for the challenge treatment, the 10.0% test substance concentration in vaseline was initially established. Since, after the first induction inthe main study, skin irritation occurred in eight of 20 test animals, for the following inductions and for the challenge treatment, the test substance concentration was decreased to 1.0%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Control group: 10 animals (Vehicle treated)
- Site: left flank
- Test groups: 20 animals
- Frequency of applications: single exposure (Induction 1 (day 0) and Inductions 2 (day 7) and 3 (day 14))
- Duration: 0-14 d
- Concentrations: Induction 1: 10.0% Induction 2 and 3: 1.0%
B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day of challenge: day 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals (Test substance treated)
- Site: right flank
- Concentrations: 1.0%
- Evaluation (hr after challenge): 6, 24, 48, 72 hours - Challenge controls:
- 10 control animals were used in the main study.
- Positive control substance(s):
- not required
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 20 animals displayed no effects
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental condition chosen, test substance was assessed as non-sensitising to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the test substance was assessed in female guinea pigs using a closed patch test according to Buehler, following OECD guideline 406 and conducted under GLP conditions. The test substance was initially prepared at 10% in Vaseline. In the induction phase, 0.5 mL of the test substance preparation was applied onto the clipped skin of the left flank of 20 animals for 6 h using an occlusive dressing. The control group (10 animals) was treated similarly with the vehicle only. This procedure was repeated twice at weekly intervals. However, due to skin irritation effects, the second and third induction treatments as well as the challenge treatment were performed with the test substance at 1% in Vaseline. Fourteen days after the last induction application, the test substance preparation was applied to the clipped skin of the right flank of all animals for 6 h. Skin reactions were evaluated 6, 24, 48 and 72 h after the challenge application.
Twenty-four hours after the first induction treatment, signs of irritation were observed in 8/10 test animals in the form of very slight to moderate erythema and very slight edema, generally as localized skin reactions. No skin reactions were observed after the second and third induction treatments. Control group animals exhibited no signs of skin irritation.
The challenge treatment, immediately after patch removal, and after 24, 48, 72 hours, did not lead to signs of skin irritation in test or control group animals. No other treatment-related effects were observed. The maximum percentage of animals sensitised was 0 %. Animals of both groups survived throughout the test period. No signs of toxicity were recorded (Study director 1993c).
Further data available on the test substance is limited to a not reliable study, in which guinea pigs were induced by a total of 10 intradermal applications of the test substance at 0.5% in water, 3 times weekly for 3 weeks. Two weeks after the induction phase, test and control animals were challenged by a single intradermal application of the test substance at 0.1% in water. Skin reactions were evaluated 24 h thereafter. Skin reactions (not specified) were observed in 4/8 test animals and in all 8 animals of the control group (CHIMOSA 1979).
Migrated from Short description of key information:
The test substance is not a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
The most criticial valid study data was selected.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation is conclusive but not sufficient for classification according to DSD (67/548/EEC) and GHS (CLP, 1272/2008/EC).
There is no data available on the respiratory sensitisation potential. Thus, classification is not possible due to data lacking.
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