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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- T-13
- IUPAC Name:
- T-13
- Test material form:
- other: liquid
- Details on test material:
- - Analytical purity: 88%
- Lot/batch No.: 030522 (olefin content <0.1%%)
- Appearance: clear colourless liquid
- Expiration date of the lot/batch: 25 November 2005
- Storage conditions: 4°C in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 3.35 to 3.59
- Housing: housed individually in stainless steel cages with perforated floors
- Diet (e.g. ad libitum): 125 g standard laboratory rabbit diet available each day
- Water: ad libitum, drinking water
- Acclimation period: yes, duration not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark
IN-LIFE DATES: From: To: 9 February to 16 March 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration: 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: from the dorsolumbar region of each rabbit exposing an appropriate sized area of skin.
- % coverage: not reported
- Type of wrap if used: for exposures of one hour or more each treatment site was covered with cotton wool and elasticated bandage dressing for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: a single animal received three exposures (of three minutes, one or four hours duration) in a step-wise manner and acted as a preliminary screen. In the absence of a severe effect on removal of the dressings the next exposure was initiated.
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema ...............................................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................................................1
Well defined erythema ..................................................................................................................................2
Moderate to severe erythema .......................................................................................................................3
Severe erythema (beef redness) to eschar formation (injuries in depth) preventing grading of erythema.............4
Maximum possible: 4
Oedema Formation
No oedema....................................................................................................................................................0
Very slight oedema (barely perceptible) .........................................................................................................1
Slight oedema (edges of area well defined by definite raising) ..........................................................................2
Moderate oedema (raised approximately 1 mm) .............................................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ...........................................4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 4h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 4h exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 3rd animal not required
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: not applicable - 3rd animal not required
- Irritation parameter:
- edema score
- Remarks:
- 4h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Remarks:
- 4h exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 3rd animal not required
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 3rd animal not required
- Irritant / corrosive response data:
- Positive indication of irritation based on erythema mean score of 2.5 for 2 animals
Any other information on results incl. tables
3 -minute exposure
Well-defined erythema with or without very slight or slight oedema was apparent during the first four days after removal of the dressings. On Day 6 and 8 very slight erythema and exfoliation were evident; exfoliation alone was apparent on Day 15.
The Primary Irritation Index after 3 minute exposure was calculated to be 3.0; the mean score for the assessment 24, 48 and 72 hours after bandage removal reached the EC classification threshold. Accordingly, a 3 minute exposure of T-13 gave rise to a 'moderate irritant' response which would, if seen in two or more animals, warrant labelling with R38 "Irritating to skin" risk phrase.
1 -hour exposure
Very-slight or well-defined erythema with or without very slight oedema was evident throughout the first week after bandage removal; from 24 hours after bandage removal resolving during the second week the reaction was noted to have spread beyond the application site and from Day 6 exfoliation was apparent. Exfoliation alone was evident on Day 15.
The Primary Irritation Index after 1 hour exposure was calculated to be 3.0; the mean score for the assessment 24, 48 and 72 hours after bandage removal reached the EC classification threshold. Accordingly, a l hour exposure of T-13 gave rise to a 'moderate irritant' response which would, if seen in two or more animals, warrant labelling with R38 "Irritating to skin" risk phrase.
Four hour exposure
Well-defined or moderate to severe erythema with or without very slight or slight oedema was apparent throughout the first week after bandage removal; a clear staining on the periphery of the test site was evident during this time. One animal additionally showed blanching of the test site during the first four days of observations, loss of flexibility on Days 6 and 8, sensitivity to touch 24 hours after bandage removal and the reactions spread beyond the application site. Exfoliation was apparent in both animals during the last week of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritating according to CLP classification criteria
- Conclusions:
- According to CLP classification criteria, irritation Cat 2 applies when erythema or odema scores are >=2.3 - <=4.0 in two out of three animals. In this study a conclusion on classification for irritation could be made with the use of only 2 animals (erythema score 3 in one animal and erythema score 2 in the other animal). On this basis the substance is classified as irritant Cat 2.
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