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EC number: 248-096-5 | CAS number: 26896-48-0
- 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
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 9 DEC 1980 to 2 JAN 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with marginal deviations; number of test animals restricted to 10; no data on purity of test substance.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The study is a pre-guideline study following the experimental procedure of Magnusson and Kligman (J. Invest. Derm. 1969, 52, 268-276).
. - GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The method used is equivalent to the Guinea Pig Maximisation Test (GPMT) of OECD Guideline 406 (Skin Sensitisation)
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Tuck and Sons Limited, Battlesbridge, Essex, England
- Age at study initiation: no data
- Weight at study initiation: 300 - 450 g
- Fasting period before study: no data
- Housing: in groups of 5 animals in solid floor polypropylene cages furnished with softwood sawdust
- Diet (e.g. ad libitum): guinea pig diet, J. Waring (Feeds) Limited, Shardlow, Derbyshire, England, supplemented with a daily ration of hay together with vitamin C tablets (Redoxon 200, Roche Products Limited) dissolved in the drinking water.
- Water (e.g. ad libitum): yes
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 /14 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: isopropyl alcohol
- Concentration / amount:
- Intradermal induction:
- 0.1 mL FCA
- 0.1 mL of 5% test substance in isopropyl alcohol
- 0.1 mL of 5% test substance in isopropyl alcohol emulsified in FCA
Epicutaneous induction:
- pure test substance
Challenge exposure:
- pure test substance - Route:
- epicutaneous, occlusive
- Vehicle:
- other: isopropyl alcohol
- Concentration / amount:
- Intradermal induction:
- 0.1 mL FCA
- 0.1 mL of 5% test substance in isopropyl alcohol
- 0.1 mL of 5% test substance in isopropyl alcohol emulsified in FCA
Epicutaneous induction:
- pure test substance
Challenge exposure:
- pure test substance - No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS
Intradermal injection
Four simultanous intrademal injections with 0.1 mL of a solution of 1% and 5% test substance in isopropyl alcohol were examined (one test animal for each concentration). Observations were made 24, 48, and 72 hours and 7 days following treatment.
Topical application
Test material at two concentration (100% and 50% test substance in petrolatum) was topically applied under an occlusive patch to four sites on the shaved backs of four test animals. Each animal was treated with both concentrations and had previously been intradermally injected with Freud Complete Adjuvant.The degree of irritancy at the test sites were evaluated for erythema immediately after removal of the patches and then at 24 and 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: epicutaneous induction: 48 hrs, occlusive application
- Test groups: TS in vehicle and TS with vehicle in FCA
- Control group: only vehicle and vehicle in FCA (no TS)
- Site: area measuring 4 x 6 cm in the shoulder region
- Frequency of applications: epicutaneous induction 7 days after intradermal induction
- Duration: 0-9 days
- Concentrations: same throughout see above under Concentration
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 (14 days after topical induction)
- Exposure period: 24 hrs
- Test groups: TS
- Control group: TS
- Site: flank of animals
- Concentrations: 100% test substance, occlusive application
- Evaluation (hr after challenge): 48 and 72 hours after start of challence (24 and 48 hours after removal of the patches)
OTHER
24 hours before epicutaneous induction, the exposure area was pretreated with 10% sodium lauryl sulfate in petrolatum.
Effects of the challenge exposure were graded according to Magnusson and Kligman 1969. - Challenge controls:
- A group of 5 animals received similar treatment to the test group except that the test material vehicle alone was used, instead of the test material, at the Intradermal and Topical Induction stages.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- pure test substance
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- scattered mild redness
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: pure test substance. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: scattered mild redness.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- pure test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: pure test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The authors regarded the test material to be a mild (Grade II) contact sensitizer in the guinea pig. However, only a small number of test animals (10) was used and only 1/10 animals showed a marginal reaction.
- Executive summary:
In a dermal sensitization study with octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol DM), ten female Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligman (equivalent to OECD Test Guideline 406 - Skin Sensitization).
One of ten tested animals showed scattered mild redness (score 1) at the challenge site at 48 hours but not any longer at 72 hours after start of challenge exposure (Collier/Safepharm, 1981b).
In this study, octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol DM) is not a dermal sensitizer according to EU Legislation.
This dermal sensitization study is acceptable and satisfies the guideline requirement for a skin sensitization study (OECD 406).
Reference
One animal of the test group showed scattered mild redness (score 1) at the challenge site at the 24 hour reading. No reaction was observed in the controls.
As no reaction was observed in the control animals, the authors attributed this effect to contact sensitization.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a dermal sensitization study with octahydro-4,7-methano-1H-indenedimethanol (TCD Alcohol DM), ten female Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligman (equivalent to OECD Test Guideline 406 - Skin Sensitization).
One of ten tested animals showed scattered mild redness (score 1) at the challenge site at 48 hours but not any longer at 72 hours after start of challenge exposure (Collier/Safepharm, 1981b).
In this study, octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol DM) is not a dermal sensitizer according to EU Legislation.
This dermal sensitization study is acceptable and satisfies the guideline requirement for a skin sensitization study (OECD 406).
Migrated from Short description of key information:
In a dermal sensitization study octahydro-4,7-methano-1H-indenedimethanol (TCD Alcohol DM) did not exhibit dermal sensitisation.
Justification for selection of skin sensitisation endpoint:
Only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
No required endpoint according to Regulation (EC) No 1907/2006.
Justification for classification or non-classification
In a guinea pig maximisation, only 1 out of 10 test animals showed scattered mild redness (grade 1) at the challenge site at 48 h (with intradermal induction injection of 0.1 mL), no signs were visibla at 72 h. According to Regulation (EC) No 1272/2008, classification is not required (< 30% of the animals showed positive reactions).
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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