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EC number: 260-789-4 | CAS number: 57526-50-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Initiation: July 13, 1983 - Termination: September 15,1983.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study, no information on test item purity, no positive control
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study performed before LLNA method was established
Test material
- Reference substance name:
- Octahydro-4,7-methano-1H-indene-5-methanol
- EC Number:
- 260-789-4
- EC Name:
- Octahydro-4,7-methano-1H-indene-5-methanol
- Cas Number:
- 57526-50-8
- Molecular formula:
- C11H18O
- IUPAC Name:
- {tricyclo[5.2.1.0²,⁶]decan-8-yl}methanol
- Test material form:
- liquid
- Details on test material:
- Chargen Nr. RM 13 2414
no information on purity
1
- Specific details on test material used for the study:
- No information on purity. However, as it is stated in the section 13, the substance and its composition have remained essentially the same over the last decades.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Weight at study initiation: mean 233.4 g (range: 189-261)
- Housing: in groups of 5 per cage in fully air-conditioned rooms
- Diet: mixed feed for breeding rabbits and guinea pigs ERKA 8300 (R. Koch OHG, Hamm), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours per day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- a) 50 % FCA in isotonic saline; b) test substance (5 %) in vehicle; c) test substance (5 %) in FCA
- Day(s)/duration:
- 1 d
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- pure substance
- Day(s)/duration:
- 2 d
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- pure test substance
- Day(s)/duration:
- 1 d
- Adequacy of challenge:
- other: highest technically applicable concentration used
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% in vehicle
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals in control group, 20 in test group
- Details on study design:
- 1st application: Induction 5 % intracutaneous
(day 1)
2nd application: Induction 100 % occlusive epicutaneous (day 9)
3rd application: Challenge, pure substance occlusive epicutaneous (day 22)
4th application: Challenge 50 % occlusive epicutaneous (day 35, after effects of first challenge totally subsided) - Challenge controls:
- 2
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not specified
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- marginal to well defined erythema
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- marginal erythema, hardened skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- marginal erythema
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- marginal (5) to well defined (1) erythema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
first challenge / undiluted test substance:
first reading (24 h after patch removal: 9/10 (90%) control animals with erythema and 14/20 (70%) of test animals with erythema
second reading (48 h after patch removal: 5/10 (50%) control animals with erythema and 12/20 (60%) of test animals with erythema; no oedema in control animals, 1/20 test animals with oedema
second challenge/ undiluted test substance:
first reading (24 h after patch removal: 10/10 (100%) control animals with erythema and 14/20 (70%) of test animals with erythema; 5/10 (50%) controls animals with oedema and 1/20 (5%) test animals with oedema
second reading (48 h after patch removal: 8/10 (80%) control animals with erythema and 15/20 (75%) of test animals with erythema;
4/10 (40%) controls animals with oedema and 3/19 (16%) test animals with oedema
second challenge / 50% test substance in petrolatum:
Skin reaction 24 hours after patch removal:
No difference was noted between control and treated animals.
Skin reaction 48 hours after patch removal:
Marginal skin reactions were noted in treated animals: 5% increase in weak erythema and 5% increase in well-defined erythema compared to the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this test the test substance did not show sensitising properties.
- Executive summary:
The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406 and GLP. Intradermal induction was performed with 5% test substance in parraffin and dermal induction with undiluted test item. First challenge was performed with undiluted test substance. However, due to irritating effects already observable in the control group no evaluation with respect to sensitising effects was possible. The second challenge was performed with undiluted test substance (left flank) and 50% test substance in petrolatum (right flank). Again, no evaluation of the left flanks was possible due to irritating effects already observable in the control group. Treatment with 50% test substance in petrolatum did not cause skin sensitisation.
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