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Diss Factsheets
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EC number: 422-210-5 | CAS number: 68957-94-8 T3P
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-07-24 to 1995-08-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted in 1995 and was considered as appropriate to cover this endpoint. The test substance is hydrolytically instable.
Test material
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: HOE CG 0501 0DZD00 0001
- Expiration date of the lot/batch: June 1996
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness at room temperature in a fume cupboard
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: guaranteed for 4 h
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany, SPF breeding colony
- Weight at study initiation: 377g -5.6%/+8.2%
- Housing: Makrolon cages in fully air conditioned rooms
- Diet: ssniff Ms-H (V2233) ad libitum
- Water: ad libitum
- Acclimation period: not necessary, breeding at identical conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 14
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 %
- Day(s)/duration:
- on day 29
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- control group: 10, test group: 20
- Details on study design:
- RANGE FINDING TESTS:
The primary non-irritant concentration was determined using the concentrations: 100%, 50% and 10% in petrolatum.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 14 days
- Test groups: 20 animals were treated with the undiluted substance
- Control group: 10 control animals treated with vehicle
- Site: left flank
- Frequency of applications: once a week
- Duration: 6h
- Concentrations: 100 %, control group: vehicle
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 29
- Exposure period: 6 h
- Test groups: 50 % test substance in vehicle
- Control group: vehicle only
- Site: right flank
- Concentrations: 50 %
- Evaluation (hr after challenge): 24 h
- Challenge controls:
- none
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % substance in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test substance in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Signs of irritation during induction:
Partly very slight up to moderate erythma and very slight oedema were observed in the treatment group. After the 3. application in 2 test animals the treated skin was dry and rough. The control animals showed no irritations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not cause skin sensitisation in this Bühler assay.
- Executive summary:
In order to test for the sensitizing property of the test substance by the Buehler method, 6 Pirbright White guinea pigs were used to determine the primary non-irritant concentration to be used for the challenge applications, 10 animals served as control during the main test and were only treated with the vehicle (petrolatum), and further 20 animals were used as test group.
All applications were carried out using occlusive dressing and for a duration of 6 hours.
In the preliminary test the following concentrations were used: 100 %, 50 % and 10 %, 50 % was found to be the highest concentration not causing dermal irritation.
During induction, the test substance was administered undiluted to the left flank of all test animals. 3 applications were carried out during the induction phase (day 1-15). After the third application the treated skin of two animals was dry and rough. No treatments were carried out on days 16 to 28. On days 29 the challenge treatment was conducted using 50 % test-substance .
Examinations of the skin followed on the next day (30) and on days 31. No changes/signs of irritation occurred after the challenge treatment.
The test material showed no evidence for sensitizing property.
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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