Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 264-391-1 | CAS number: 63663-21-8
- 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
Skin Sensitisation
Under the conditions of the study, the test material is not considered to be a skin sensitiser.
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:
- 14 September 2006 to 20 December 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiences which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study coducted for worldwide regulatory purposes.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 503226
- Expiration date of the lot/batch: March 01 2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in well closed containers (21 to 25 °C) - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 334 to 394 g
- Housing: animals were housed individually or in groups of 2 animals in stainless-steel wire-mesh cages (w 266 x d 266 x h 200 mm)
- Diet:pellet diet (ad libitum)
- Water: Tap water was supplied via an automatic water supplying system.
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 5 °C (measured values: 19 to 28 °C)
- Humidity: 55 ± 25 % (measured values: 36 to 85 %)
- Air changes: 11 to 14 times per hour
- Photoperiod: 12-hour lighting (07:00 to 19:00) - Route:
- other: intradermal and topical
- Vehicle:
- other: liquid paraffin for intradermal and polyethylene glycol 300 for topical induction and challenge
- Concentration / amount:
- 25 % (w/w) for intradermal, 50 % (w/w) for topical.
- Day(s)/duration:
- Intradermal induction on day 1, Topical induction on day 6 (patch applied for 48 hours)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- other: Topical
- Vehicle:
- polyethylene glycol
- Remarks:
- 300
- Concentration / amount:
- 50 % (w/w) and 25 % (w/w)
- Day(s)/duration:
- Twenty-one days after the first intradermal injection the challenge was applied for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals for the test material group and 5 animals for the control group.
- Details on study design:
- PRELIMINARY STUDY TO SELECT DOSE CONCENTRATIONS
-Two selected animals were clipped on their dorsal skin and 0.1 mL of test material suspension (at 25, 10, 5 and 1 % w/w) was injected intradermally to sites A to D.
-Two animals were then clipped and shaved on the scapula area and 0.1 mL of 1:1 emulsion of physiological saline and Freund's complete adjuvant (FCA) was injected intradermally to the four corners of the area. Seven days later fur of 3 x 7 cm on the right and left flanks was clipped and shaved and 0.1 mL of each test material suspension (50, 25, 10, 5, 2.5 and 1 % w/w) was applied to a patch 1.5 cm in diameter. The patch was applied to the shaved skin and covered occlusively with a polyethylene film tape. The patch was removed after 24 hours and the site cleaned with absorbent cotton soaked with polyethylene glycol 300.
-Animals were observed for skin reactions at 24 and 48 hours after intradermal injection or patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
-Site: On the day before intradermal induction, fur of a 4 x 6 cm area above the scapula was clipped with an electric clipper and further shaved with an electric shaver as closely as possible.
- Intradermal induction: On the next day, 0.1 mL of each intradermal sensitiser used in this study was intradermally administered to the induction sites (A, B and C) within the 2 x 4 cm area.
- Topical induction: On day 6 after intradermal induction, the same area was clipped and shaved with an electric clipper and shaver and 0.2 mL of white petroleum containing 10 % SLS was applied (to D (2 x 4 cm)) between the intradermal induction sites. On the next day, this area was cleaned with absorbent cotton soaked with ether, 0.2 mL of each topical sensitiser was applied to a patch 2 x 4 cm and the patch was applied to the induction area (D) and covered occlusively with a polyethylene film tape for topical induction. The patch was removed 48 hours after application.
B. CHALLENGE EXPOSURE
- Site: Twenty days after intradermal induction, fur of the left flank (approximately 3 x 7 cm) of all animals was clipped with an electric clipper and further shaved with an electric shaver as closely as possible. On the next day, 3 sites (E to G) for challenge were provided for each animal and 0.1 mL of each substance for challenge test suspensions at 2 concentrations (50 and 25 % w/w) and polyethene glycol was applied via a patch 1.5 cm in diameter, which was fixed in place with a polyethylene film tape for 24 hours for occlusive application of challenge.
- Exposure period: 24 hours.
- Evaluation (hr after challenge): Observations of the application sites were made 24 hours and 48 hours after removal of the application for challenge and skin reactions were scored and recorded.
OBSERVATIONS
-Animals were observed for clinical signs once daily for the duration of the study (Day 0 to Day 24).
-Animals were weighed on the starting day (Day 0), the day of topical induction (Day 7), the day of challenge (Day 21) and the final observation day (Day 24).
-Observations of skin reactions were performed at 24 and 48 hours after removal of the challenge application. Skin reactions were scored according to the following:
0 = No visible change
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling
EVALUATION
-For each application challenge site the severity of skin reaction was scored, the mean score for each test group at each observation time point was calculated and the positive reaction rate [(the number of animals with a score of 1 or above) / (the number of animals used) x 100] was determined. The sensitisation potential of the test material was assessed by comparison of the mean score and positive reaction rate between the test material and control groups.
-The test material was judged to be positive if the mean score and the positive reaction rate were higher in the test material group. - Challenge controls:
- 50 and 25 % for 24 hours exposure.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (MBT)
- Positive control results:
- No positive control group was provided in this study but 2-Mercaptobenzothiazole (MBT) study data has been conducted at the test facility. Clear sensitisation potential of MBT was observed and thus the experimental procedure used in the facility is appropriate.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- other: Not sensitising in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the test material is not considered to be a skin sensitiser.
- Executive summary:
The skin sensitisation potential of the test material was determined in accordance with the standardised guideline OECD 406 using a guinea pig maximisation test.
The study was performed in female Hartley guinea pigs and a preliminary study was performed first to determine the test material concentrations suitable for use. For the intradermal injection the maximum concentration not causing necrosis was set at 25 % w/w and for the topical induction was set at 50 % which was the maximum physically applicable concentration. The challenge application was set at 50 % (the maximum non irritating concentration) and 25 % (half thereof). In the main study animals were subjected to intradermal application on Day 0 and on Day 6 they received a topical induction which was applied for 48 hours. The challenge was performed on Day 20 and was applied for 24 hours with observations at 24 and 48 hours post removal.
No skin reactions were observed in the test material treatment group after challenge at either 50 or 25 % w/w concentration, the mean score was 0 and the positive reaction rate was 0 %. The same results were seen in the control group. In clinical signs and bodyweight data there were no abnormalities that were thought to be attributable to application of the test material. The positive control data showed that the experimental procedure was valid.
Under the conditions of this study it was concluded that the test material had no skin sensitisation potential.
Reference
Preliminary studies
-Intradermal injection: Erythema of score 2 or 1 was observed at concentrations 25 and 10 % w/w and erythema score of 1 was observed at concentrations 5 and 1 % at 24 and 48 hours post administration in 2/2 or 1/2 animals, however necrosis was not observed. As a result the concentration for intradermal induction was set at 25 % w/w (maximum concentration with no necrosis).
-Topical induction / challenge: No skin reactions were observed at 50, 25, 10, 5, 2.5 or 1 % w/w at 24 or 48 hours after patch removal. As a result the concentration was set at the maximum applicable concentration of 50 % w/w for the topical induction.
Main Study Treatment Group
There were no skin reactions in the observation at 24 or 48 hours after removal of the application in any animal at 50 or 25 % test material dose. The mean score was therefore 0 and the positive reaction rate was 0 %. There was no reaction in any animal to the vehicle so positive reaction rate for the vehicle group was also 0 %.
Control group
There were no skin reactions in the observation at 24 or 48 hours after removal of the application in any animal so reaction rate was 0 % for both 25 and 50 % test material dosage.
Observations:
- Clinical observations: Animals were observed for clinical signs once daily from the starting day of induction (Day 0) to the end of skin observation after challenge (Day 24). During the study period, there were no abnormalities in clinical signs observed.
- Body weight: all animals were weighed on the starting day of induction (Day 0), day of topical induction (Day 7), day of challenge (Day 21) and the final day of observation (Day 24). At the final day of observation (Day 24), a body weight decrease in comparison with previous value (Day 21) was observed in 3/10 animals in the test material group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Guinea Pig Maximisation - Key Study (Hara, 2006)
The skin sensitisation potential of the test material was determined in accordance with the standardised guideline OECD 406 using a guinea pig maximisation test. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
The study was performed in female Hartley guinea pigs and a preliminary study was performed first to determine the test material concentrations suitable for use. For the intradermal injection the maximum concentration not causing necrosis was set at 25 % w/w and for the topical induction was set at 50 % which was the maximum physically applicable concentration. The challenge application was set at 50 % (the maximum non irritating concentration) and 25 % (half thereof). In the main study animals were subjected to intradermal application on Day 0 and on Day 6 they received a topical induction which was applied for 48 hours. The challenge was performed on Day 20 and was applied for 24 hours with observations at 24 and 48 hours post removal.
No skin reactions were observed in the test material treatment group after challenge at either 50 or 25 % w/w concentration, the mean score was 0 and the positive reaction rate was 0 %. The same results were seen in the control group. In clinical signs and bodyweight data there were no abnormalities that were thought to be attributable to application of the test material. The positive control data showed that the experimental procedure was valid.
Under the conditions of this study it was concluded that the test material had no skin sensitisation potential.
Buehler Test - Supporting study (Ueno, 2000)
The potential of the test material to cause skin sensitisation in female Hartley guinea pigs was determined using the Buehler test. Three different lots of test material (1, 2 and 3) were tested. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
In each sensitising group of test material 1, test material 2, and test material 3, sensitisation was induced at 25 % concentration of each test material. Sensitisation was performed three times per week for nine doses. Challenge was treated with 25 and 10 % and petrolatum one day after the last sensitisation dose. For observation of skin sensitisation, any skin reaction was not seen as with controls which were induced sensitisation with petrolatum, and treated challenge with each test material sensitising group at the same concentrations.
In clinical signs and bodyweights, any anomaly due to the test substance was not observed in any test group during observation period.
Under the conditions of the study, three different lot numbers of the test material are not considered to be skin sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin sensitisation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.