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EC number: 947-744-0 | CAS number: -
- 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
In order to assess the skin sensitizing property of Hostacerin DGSB one OECD 406 study (Buehler) in guinea pigs is available. In a pretest the primary non irritating concentration was determined in 2 animals per dose. Doses tested were 4, 20, 100 % in paraffin oil (DAB) which were exposed to the left flank and covered occlusive for 6 hours.24 hours after removal of patch, the treated skin area was examined for erythema and edema building. No erythema or edema could be detected at any dose group.
For the main study 20 female guinea pigs were treated with 0.5g of 100% test item prepared in paraffin oil (DAB) and 10 animals of control group were treated with 0.5 mL of Vehicle. Dermal induction was performed on the clipped left flank at days 1, 8 and 15 using the same application scheme as for the pretest. 24 hours after removal of patch, the treated area was examined for erythema and edema building. Days 16 to 28 were treatment free. At day 29 the challenge was performed on the untreated, clipped right flank. Dose group and control group were treated identically. Each 0.5g of 100 % test item prepared in paraffin oil (DAB) was applied the clipped backmost right flank and 0.5 mL of vehicle was applied to the anterior part of the clipped right flank. The treated area was covered occlusive for a period of 6 hours.At challenge phase 24 hours and 48 hours after removal of occlusive patch the treated areas wereexamined for erythemaand edema buildng. No reaction of the skin could be observed either at all animals treated nor in vehiclee control animals.
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:
- 1994-02-21 to 1994-04-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12th 1981; updated July 17th, 1992
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed 1994 prior to implementation of LLNA and appropriate in vitro methods to avoid animal testing
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: E 06213804 (date of production: 1994-12-10), soft wax
- Expiration date of the lot/batch: Stable until December 1995
- Purity test date: 1994-01-20
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark, at room temperature, in a fume cupboard
- Stability under test conditions: Stable until December 1995
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Paraffinum Liquidum, DAB, viscous, used as vehicle - Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 4, 20 and 100 %; (0.5g of test substance in vehicle or prepared with vehicle or 0.5 mL of vehicle control)
- Day(s)/duration:
- Treatment at day 1, 8 and 15; Observation period day 16 to day 28.
- Adequacy of induction:
- other: primary not irritating concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 100% (0.5 g of test item was prepared with 0.3 mL Paraffin vicous DAB)
- Day(s)/duration:
- Dermal challenge at day 29. Evaluation of dermal reactions at day 30 and day 31.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 at control group
20 at treatment group - Details on study design:
- RANGE FINDING TESTS:
Yes Determination of the primary not irritating concentration
2 animals per dose. Left flank was clipped.
Dose tested: 4, 20 and 100 % in paraffin oil (DAB)
Exposure: occlusive, 6 hour.
24 hours after removal of patch, the treated skin area was examined for erythema and edema building. No erythema or edema could be detected at any dose group.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours each
- Test groups: 1
- Control group: 1
- Site: left flank, clipped
- Frequency of applications: day 1, 8 and 15
- Duration: 6 hours
- Concentrations: 100 % moistened with paraffin oil (0.5 g with 0.3 mL Paraffin oil DAB)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: right flank, clipped
- Concentrations: 100% moistened with paraffin oil (0.5 g with 0.3 mL Paraffin oil DAB)
- Evaluation (hr after challenge): At challenge phase 24 hours and 48 hours after removal of occlusive patch no reaction of the skin could be observed either at all animals treated nor in vehicle control animals.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Vehicle
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Vehicle
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results from an in Buehler sensitization test in Pirbright-White guinea pigs the test item is a non sensitizer skin.
- Executive summary:
In order to assess the skin sensitizing property of Hostacerin DGSB one OECD 406 study (Buehler) in guinea pigs is available. In a pretest the primary non irritating concentration was determined in 2 animals per dose. Doses tested were 4, 20, 100 % in paraffin oil (DAB) which were exposed to the left flank and covered occlusive for 6 hours.24 hours after removal of patch, the treated skin area was examined for erythema and edema building. No erythema or edema could be detected at any dose group.
For the main study 20 female guinea pigs were treated with 0.5g of 100% test item prepared in paraffin oil (DAB) and 10 animals of control group were treated with 0.5 mL of Vehicle. Dermal induction was performed on the clipped left flank at days 1, 8 and 15 using the same application scheme as for the pretest. 24 hours after removal of patch, the treated area was examined for erythema and edema building. Days 16 to 28 were treatment free. At day 29 the challenge was performed on the untreated, clipped right flank. Dose group and control group were treated identically. Each 0.5g of 100 % test item prepared in paraffin oil (DAB) was applied the clipped backmost right flank and 0.5 mL of vehicle was applied to the anterior part of the clipped right flank. The treated area was covered occlusive for a period of 6 hours. At challenge phase 24 hours and 48 hours after removal of occlusive patch the treated areas were examined for erythema and edema buildng. No reaction of the skin could be observed either at all animals treated nor in vehicle control animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Based on the available test result for skin sensitization and in accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, it is concluded, that the test substance registered does not require classification for skin sensitization.
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