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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 907-728-6 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- GPMT test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 17 September and 12 October 1991.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- The information is used for read across to Rosmarel. The GPMT test with Prismantol was performed before LLNA or in vitro tests became the first test of selection.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- GPMT test
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across information
- Justification for type of information:
- The full read-across document can be found in the Endpoint Summary in text and in the attached file.
- Reason / purpose for cross-reference:
- read-across source
- Justification for non-LLNA method:
- The GPMT test was performed before LLNA or in vitro tests became the first test of selection.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Localized dermal reactions, dryness and sloughing of the epidermis
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Localized dermal reactions, dryness and sloughing of the epidermis
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% and 1% formalin
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- 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:
- other: Skin sensitizer Category 1B
- Remarks:
- According to EU CLP (EC/1272/2008 and its amendments).
- Conclusions:
- Skin sensitisation: sensitising (sensitizer 1B), based on read-across from Prismantol, which was tested in OECD TG 406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT test was performed before LLNA or in vitro tests became the first test of selection.
Test material
- Reference substance name:
- 4-methyl-8-methylenetricyclo[3.3.1.13,7]decan-2-ol
- EC Number:
- 406-330-5
- EC Name:
- 4-methyl-8-methylenetricyclo[3.3.1.13,7]decan-2-ol
- Cas Number:
- 122760-84-3
- Molecular formula:
- Hill formula: C12 H18 O CAS formula: Not Given
- IUPAC Name:
- 4-Methyl-8-methylene-tricyclo[3,3,1,1(3,7)]decan-2-ol
1
- Specific details on test material used for the study:
- The test substance was gently melted in a water bath at 60°C and prepared prior to each application in Alembicol D.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Sex: females, nulliparous and non-pregnant
- Age at Acclimatization Start: ap. 6 to 7 weeks of age
- Weight at Acclimatization Start: 304 to 353 g
- Housing: in groups of ten in suspended metal cages with wire mesh floors.
- Diet: a vitamin C-enriched guinea-pig Diet F.D.1. and drinking water were provided ad libitum. Hay was given weekly to provide dietary supplement. The routine analyses of diet and water was done.
- Water: free access to tap water
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Remarks:
- Supplied by Alembic Products, Saltney, Chester, England
- Concentration / amount:
- 7.5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Remarks:
- Supplied by Alembic Products, Saltney, Chester, England
- Concentration / amount:
- 60%
- Day(s)/duration:
- 48 h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Remarks:
- Supplied by Alembic Products, Saltney, Chester, England
- Concentration / amount:
- 25 and 50%
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- Test animals: 20
Control animals: 10 - Details on study design:
- RANGE FINDING TESTS
- Intradermal injections:
Intradermal injections were made into the clipped flank of animals at concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0% of the test substance in Alembicol D. The reactions were examined after 24 and 72 hours for size, erythema and oedema.
As well-defined erythema (grade 2) was observed with 7.5% in both animals, this concentration was selected as the intradermal induction concentration.
- Epidermal application:
Patches of filter paper (2x4 cm) were saturated with 0.4 ml of the undiluted test substance at the concentration of 60% in Alembicol D. These were applied to the clipped and shaved flanks of each of 2 males and 2 females and were covered by a length of impermeable plastic adhesive tape. This was firmly secured by elastic adhesive bandage wrapped around the trunk and fixed with "Sleek" impervious plastic adhesive tape. The patches were removed 48 hours after application and the treatment sites were examined immediately and 24 hours and 48 hours after removal of the patches.
At 60% in three animals only very slight erythema (grade 1) was observed immediately after patch removal and in three animals after 24 and 48 hours, in one animal a well-defined erythema (grade 2) was observed after 24 and 48 hours, and in one animal a necrotic patch was observed. Therefore, this concentration was used for the topical induction concentration.
As at 50% no erythema was observed at any time of observation, this concentration was used for the highest challenge exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
1) Intradermal injections (0.1 ml)
- Concentration: 7.5%
- Site: the dorsal scapular region
Three pairs of intradermal injections:
1) Freund's complete adjuvant (FCA) 50:50 with water for irrigation
2) Test substance at 7.5% in Alembicol D
3) Test substance at 7.5% in Alembicol D in a 50:50 mixture of FCA with Alembicol D
Control group:
1) Freund's complete adjuvant (FCA) 50:50 with water for irrigation
2) Alembicol D
3) 50:50 mixture of FCA with water for irrigation
- Readings: daily
- Results: Erythema and edema was observed in both groups
2) Topical applications one week after the injections:
- Concentration: 60%
- Amount: saturated patch (control animals: water for irrigation only)
- Area: 8 cm2
- Exposure period: 48 hours (occlusive)
- Readings: immediately after patch removal and 24 and 48 hours after patch removal
B. CHALLENGE EXPOSURE (control and test group)
- Day of challenge: 2 weeks after the epidermal induction application
- Concentrations: 25 and 50%
- Exposure period: 24 hours (occlusive)
- Sites: left flank, anterior and posterior sites
- Amount: saturated patch
- Readings: at 24, 48 and 72 hours after patch removal - Positive control substance(s):
- yes
- Remarks:
- Formalin
Results and discussion
- Positive control results:
- The results of the latest sensitivity check of August-September 1991 showed that the system was responsive (10 of 10 animals reacted positive).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Localized dermal reactions, dryness and sloughing of the epidermis
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- Localized dermal reactions, dryness and sloughing of the epidermis
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% and 1% formalin
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Preliminary study:
- At topical application of 60% no edema was observed at any time point and in three animals a very slight erythema (grade 1) was observed immediately after patch removal and in all four exposed animals after 24 and 48 hours, of which in one animal a well-defined erythema (grade 2) was observed after 24 and 48 hours, and in one animal a necrotic patch was observed. Therefore, this concentration was used for the topical induction concentration. As at 50% no erythema was observed at any time of observation, this concentration was used for the highest challenge exposure.
Main study:
- The body weight gain of the animals was normal, no signs of ill health, no systemic toxicity and no mortality was seen.
- The ten animals exposed to negative control did not show any signs of irritation.
- Intradermal injections: Application area around the injection sites (at 7.5%) was found to show a slight irritation.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sensitizer Category 1B
- Remarks:
- According to EU CLP (EC/1272/2008 and its amendments).
- Conclusions:
- In a guinea pig maximisation test performed similar to OECD 406 (1981) and according to GLP principles, the substance is considered a 1B skin sensitiser.
- Executive summary:
The skin sensitisation potential of Prismantol was tested in a guinea pig maximisation test performed similar to OECD 406 (1981) and according to GLP principles. A concentration of 7.5% was used for the intradermal induction, 60% for the epidermal induction and 25 and 50% for the topical challenge. The substance produced evidence of skin sensitization in all tested twenty animals and therefore was considered a skin sensitiser. Because ≥ 30% (100%) of animals responded at a dose of > 1% (7.5%), Prismantol is 1B sensitizer.
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.