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Reaction mass of endo-2-methyl-exo-3-methyl-exo-2-[(endo-3-methylbicyclo[2.2.1]hept-endo-2-yl)methyl]bicyclo[2.2.1]heptane and endo-2-methyl-exo-3-methyl-exo-2-[(endo-2-methylbicyclo[2.2.1]hept-endo-3-yl)methyl]bicyclo[2.2.1]heptane and endo-2-methyl-exo-3-methyl-exo-2-[(exo-3-methylbicyclo[2.2.1]hept-exo-2-yl)methyl]bicyclo[2.2.1]heptane and endo-2-methyl-exo-3-methyl-exo-2-[(exo-2-methylbicyclo[2.2.1]hept-exo-3-yl)methyl]bicyclo[2.2.1]heptane
EC number: 939-299-6 | 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 September 1997 to 30 April 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available.
Test material
- Reference substance name:
- T-12
- IUPAC Name:
- T-12
- Test material form:
- other: liquid
- Details on test material:
- - Analytical purity: >99%
- Lot/batch No.: 601 (2.7% olefin content)
- Appearance: liquid
- Expiration date: assumed stable for six months from date of receipt
- Storage conditions: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: reputable supplier of laboratory animals
- Age at study initiation: 4-7 weeks on arrival + 5 days acclimatisation
- Weight at study initiation: 338-411 g
- Housing: the guinea-pigs were housed in groups of five in suspended metal cages with wire mesh floors
- Diet: vitamin C enriched guinea-pig diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21°C
- Humidity (%): 26 to 58%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: To: 21 October to 21 November 1997
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- coconut oil
- Concentration / amount:
- Preliminary study: intradermal 0, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5, 10.0 % v/v
Preliminary study: topical: 30,50,70 % v/v
Preliminary study: challenge, 25 and 50% v/v
Main study, induction: intradermal 5% v/v
Main study, induction topical: as supplied
Main study, challenge: 25 and 50% v/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Concentration / amount:
- Preliminary study: intradermal 0, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5, 10.0 % v/v
Preliminary study: topical: 30,50,70 % v/v
Preliminary study: challenge, 25 and 50% v/v
Main study, induction: intradermal 5% v/v
Main study, induction topical: as supplied
Main study, challenge: 25 and 50% v/v
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase.
Animals for these investigations were pre-treated with an intradermal injection of Freund's complete adjuvant, 50 : 50 with water for irrigation (Ph.Eur.), approximately two weeks prior to the start of the preliminary investigations. Based on the results of the preliminary investigations, the following concentrations of T-12 were selected:
Induction intradermal injection- 5% v/v in Alembicol D (the highest concentration that caused irritation but did not adversely affect the animals).
Induction topical application - as supplied (produced some irritation but did not adversely affect the animals).
Topical challenge- 50 and 25% v/v in Alembicol D
From preliminary investigations 50% v/v in Alembicol D was the highest concentration not giving rise to irritating effects.
MAIN STUDY
A. INDUCTION EXPOSURE - intradermal
- No. of exposures: 1
- Exposure period: one week intradermal
- Test groups: 5% v/v test substance in Alembicol D; 5% v/v test substance in a 50: 50 mixture of Freund's complete adjuvant and Alembicol D.
- Control group:50/50 Freund's complete adjuvant/water for irrigation
- Site: 40 x 60 mm area of dorsal skin on the scapular region, clipped free of hair with electric clippers. Three pairs of intradermal injections made into a 20 x 40 mm area within the clipped area.
- Frequency of applications: application in duplicate (two sites)
A. INDUCTION EXPOSURE - topical
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 0.4ml test substance as supplied absorbed onto a 20 x 40 mm patch of Whatman No. 3 paper. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width). This in turn was firmly secured by elastic adhesive
bandage (50 mm width plaster) wound round the torso of the animal and fixed with impervious plastic adhesive tape.
- Control group: the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
- Site: the same 40 x 60 mm area of dorsal skin on the scapular region as used for the intradermal injections, clipped and shaved free of hair..
- Frequency of applications: application at one site
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after topical induction
- Exposure period: 24 hours
- Test and control groups: test substance in Alembicol D
- Site: hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig
- Concentrations: 50 and 25% v/v
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patch
Results and discussion
- Positive control results:
- Hexyl cinnamic aldehyde - 10/10 positive, 0/10 inconclusive or negative
Mercaptobenzothiazole - 9/10 positive, 1/10 inconclusive, 0/10 negative
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: not reported
- Hours after challenge:
- 168
- Group:
- positive control
- Dose level:
- Induction (intradermal): 10 % v/v
Induction (topical): 83.33 % v/v
Challenge: 83.33 % v/v and 40 % v/v - No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Not reported
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Mercaptobenzothiazole
- Reading:
- other: Not specified in report
- Hours after challenge:
- 168
- Group:
- positive control
- Dose level:
- Induction (intradermal): 10 % v/v
Induction (topical): as supplied
Challenge: as supplied and 50 % v/v - No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none reported
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Hexyl cinnamic aldehyde
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs of ill health or toxicity
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% and 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of ill health or toxicity.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no signs of ill health or toxicity
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% and 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no signs of ill health or toxicity.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of ill health or toxicity
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% and 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of ill health or toxicity.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of ill health or toxicity
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 and 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of ill health or toxicity.
Any other information on results incl. tables
Bodyweight increases were recorded for all guinea-pigs over the period of the study
Site |
Intradermal injection |
Topical application |
||
Test animals |
Control animals |
Test animals |
Control animals |
|
1 |
Necrosis |
Necrosis |
Slight erythema |
Slight erythema |
2 |
Slight irritation |
Slight irritation |
||
3 |
Necrosis |
Necrosis |
Control animals:
(Site 1) 0.1 ml of Freund's complete adjuvant 50: 50 with water for irrigation (Ph.Eur.).
(Site 2) 0.1 ml of Alembicol D.
(Site 3) 0.1 ml of Freund's complete adjuvant 50: 50 with Alembicol D.
Test animals:
(Site 1) 0.1 ml of Freund's complete adjuvant 50: 50 with water for irrigation (Ph.Eur.).
(Site 2) 0.1 mi of T-12, 5% v/v in Alembicol D.
(Site 3) 0.1 ml of T-12, 5% v/v in a 50: 50 mixture of Alembicol D and Freund's complete adjuvant.
A volume of 0.1 ml was injected into both the left and right injection sites.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- T-12 did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
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