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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 679-769-5 | CAS number: 2675-94-7
- 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
Skin sensitisation:
The test item is considered to have no skin sensitizing potency in guinea pigs by
Buehler test
.
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:
- From 2013-09-25 to 2013-11-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was initiated to fulfil substance notification need for jurisdictions outside of EU, in which OECD 406 is an acceptable method for skin sensitisation study.
- Specific details on test material used for the study:
- Batch No.: not specified
Purity: 99.95% - Species:
- guinea pig
- Strain:
- other: ElmSam: HA, SPF
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Samtako Bio Korea., Ltd.
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 315.69 ~ 377.49 g
- Housing: five animals per cage were housed in stainless steel cage
- Diet: be fed pellet diet for experimental guinea pig including 0.01% ascorbic acid
- Water: be given the filltered and UV irradiated water libtium
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 10~15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- Day 0, 7, 14
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 100% test substance
- Concentration / amount:
- 0.5 mL
- Day(s)/duration:
- Day 27
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 for treament, 10 for negative and positive control group
- Details on study design:
- RANGE FINDING TESTS:
-Dose level: the concentration of test substance were 4 types, 50% (v/v), 25%(v/v), 12.5%(v/v) including the highest concentration [100%; test substance] with vehicles by using a common ratio 2.
-Determination of dose levels: in the preliminary test using two animals per concentration, skin reaction were not observed at 100% concentration (test substance itself). Based on this result, concentration of 100% concentration was chosen for induction and challenge phase of the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hour , Day 0, 7, 14
- Test groups: 100% test substance
- Control group: D.W. and 1 %(w/v) DNCB
- Site: the fur on one flank was closely with a hair clipper
B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 27
- Exposure period: 6 hours
- Test groups: 100% test substance
- Control group: D.W. and 1 %(w/v) DNCB
- Site: test area (the fur on one flank was closely with a hair clipper)
- Challenge controls:
- Negative control: 100% test substance
Positive control: 1%(w/v) DNCB - Positive control substance(s):
- yes
- Remarks:
- DNCB
- Positive control results:
- In the positive control group, skin reaction of erythema was shown and sensitization index (the mean score of skin reaction) was 1.1 (24 hours) and 0.6 (48 hours). Also, the frequency index (sensitization) was 80.0% (24 hours) and 60.0% (48 hours).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormalities detected
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No abnormalities detected
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%(w/v) DNCB
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities detected
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result indicate that the test item is considered to have no skin sensitizing potency in guinea pigs by Buehler test under the conditions of this study.
- Executive summary:
The study was conducted to evaluate the skin sensitization of test item in guinea by Buehler test according to OECD 406 (1992). Parameters measured during the study period were mortality, clinical signs, body weight changes and skin reaction. The following results were obtained:
- No treatment-related mortality was observed during the study period.
- No treatment related clinical signs were observed in any treated animals.
- All living animals in treatment group showed a normal increase of body weight.
- At the 24 and 48 hours after challenge with test substance of 100%, the sensitization index (mean score of skin reaction) and frequency index (sensitization rate) were 0.0, 0.0 and 0.0 % and 0.0% at 24 and 48 hours for the test substance. In positive control, the sensitization index (mean score of skin reaction) and frequency index (sensitization rate) were 1.1, 0.6 and 80.0%, 60.0% at 24 and 48 hours after challenge, respectively.
These results indicate that the test item is considered to have no skin sensitizing potency in guinea pigs by Buehler test under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Buehler test: negative.
Therefore, according to Regulation (EC) 1272/2008 (amendment 286/2011), table 3.4.2, this substance should not be classified for skin sensitisation endpoint.
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.