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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
Endpoint summary
Administrative data
Description of key information
The substance is irritating to skin but not irritating to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to attachment for read across justification
- Reason / purpose for cross-reference:
- read-across source
- 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:
- fully reversible
- Remarks:
- 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:
- other: 3rd animal not required
- 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to attached read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, T-12, was considered to be 'Practically nonirritating' to New Zealand White rabbits eye under the conditions of this study.
Reference
No abnormal signs or symptoms were observed in any animal throughout the course of the study.
No abnormal signs of pain and distress were evident in three animals immediately after test substance application and at 1, 24, 48 and 72 hours after test substance application.
All animals exhibited normal body weight gains. The mean body weight gain throughout the observation period was 0.11 kg.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The skin irritation of T-13 was determined by HLS, 2005, Report No.: IDK 99. The study was conducted in accordance with OECD Guideline 404, EU method B4 and EPA OPPT 870.2500, and was considered reliable.
Eye irritation
The eye irritation of T-13h was determined by Biotoxtech, 2014, Report No.: B14170. The study was conducted in accordance with OECD Guideline 405 and was considered reliable.
Justification for selection of skin irritation / corrosion endpoint:
A single study is available. It is considered to be adequate and reliable.
Justification for selection of eye irritation endpoint:
A single study is available. It is considered to be adequate and reliable.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Skin irritation
Category 2: irritant
Erythema >=2.3 -< =4.0, (actual value 3) in one animal out of two. The other animal mean erythema score is 2 which, although not >-2.3 indicates and adverse effect and supports the classification requirement for the first animal. The substance also produces irreversible effects (exfoliation at day 15, other effects during observation period (blanching, loss of flexibility, staining, sensitivity to touch).
Eye irritation
Not classified
Zero scores for all animals for opacity, iritis, redness and oedema at 24, 48 and 72 hrs.
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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