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Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
EC number: 700-770-4 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-12-21 - 2011-01-08 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study has been conducted according to the standard guideline(s) with (minor) deviations and its results are reliable, relevant and adequate for risk assessment and classification. This study has been initiated (in year 2010) for other purposes than to support a registration according to Regulation (EC) No 1907/2006 (REACH). It has not been carried out in compliance with the principles of good laboratory practice (GLP), which is, according to REACH Article 13 (4), required for toxicological tests. The study has been conducted according to the standard guideline(s) with some (minor) deviations. It was conducted in a facility operating to GLP within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study. However it has been declared by the study director that the report is an accurate record of the study and its outcome. The original data are retained in the archives of the test facility. The analytical characterisation of the test material has been performed according to GLP. After assessing all information on this study, the registrant has concluded that the following conditions are met: (1) adequacy for the purpose of classification and labelling and/or risk assessment; (2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3); (3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and (4) adequate and reliable documentation of the study is provided. Thus, according to REACH Annex XI, 1.1 ("Testing does not appear scientifically necessary - Use of existing data"), these existing data are considered to be acceptable for fulfilling the information requirements of this endpoint. As a consequence, the overall reliability rating (according to Klimisch et al.) is considered to be between "reliable with restrictions" and "not reliable", but closer to "reliable with restrictions". Thus a Klimisch rating of 2 (reliable with restrictions) has been assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- minor deviations (e.g. no information is given on age of each animal at start of study, individual animal weights at start and conclusion of test, source of animals, housing conditions, diet, description of method used to score irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- minor deviations (e.g. no information is given on age of each animal at start of study, individual animal weights at start and conclusion of test, source of animals, housing conditions, diet, description of method used to score irritation)
- Principles of method if other than guideline:
- The study was performed to assess the irritation of the test item to the eye of the New Zealand White rabbit, according to a general study plan of the test facility. The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 “Acute Eye Irritation/Corrosion” and Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008.
- GLP compliance:
- no
- Remarks:
- However, the study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. The analytical characterisation of the test material has been performed according to GLP.
Test material
- Reference substance name:
- Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- EC Number:
- 700-770-4
- Molecular formula:
- C12H14Cl2O2
- IUPAC Name:
- Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- single application of 0.1 ml (approximately 78 mg)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- A single application of 0.1 ml (approximately 78 mg) of the test item was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours after administration.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no corneal opacity noted during the course of the study
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect on the iris was noted during the course of the study
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- mean cornea scores (following grading at 24, 48 and 72 hours):
0, 0 and 0 for animal #1, animal #2 and animal #3, respectively
mean iris scores (following grading at 24, 48 and 72 hours):
0, 0 and 0 for animal #1, animal #2 and animal #3, respectively
mean conjunctivae (redness) scores (following grading at 24, 48 and 72 hours):
0.67, 0.67 and 0.33 for animal #1, animal #2 and animal #3, respectively
mean chemosis scores (following grading at 24, 48 and 72 hours):
0.33, 0 and 0 for animal #1, animal #2 and animal #3, respectively
for details see Table 1 under "Any other information on results incl. tables".
Any other information on results incl. tables
Individual reactions are given in Table 1. The test item produced moderate conjunctival irritation. One treated eye appeared normal at the 48-Hour observation and two treated eyes appeared normal at the 72-Hour observation.
Maximum Group Mean Score: 9.3
Classification: mild irritant (class 4 on a 1-8 scale)
For "Draize Scale for Scoring Ocular Irritation" and "Modified Kay and Calandra Interpretation of Eye Irritation Test" see the attachment of this endpoint study record.
Table 1: Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex | 69852 Male | 69871 Male | 69873 Male | |||||||||
IPR = 2 | IPR = 2 | IPR = 2 | ||||||||||
Time After Treatment | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours |
CORNEA | ||||||||||||
E = Degree of Opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
F = Area of Cornea Involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS | ||||||||||||
D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVAE | ||||||||||||
A = Redness | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 0 | 0 |
B = Chemosis | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
C = Discharge | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Score (A + B + C) x 2 | 12 | 6 | 2 | 0 | 6 | 2 | 2 | 0 | 10 | 2 | 0 | 0 |
Total Score | 12 | 6 | 2 | 0 | 6 | 2 | 2 | 0 | 10 | 2 | 0 | 0 |
IPR = Initial pain reaction
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU: Regulation (EC) 1272/2008
- Conclusions:
- The study has been conducted according to the standard guideline(s) with (minor) deviations and its results are reliable, relevant and adequate for risk assessment and classification.
This study has been initiated (in year 2010) for other purposes than to support a registration according to Regulation (EC) No 1907/2006 (REACH). It has not been carried out in compliance with the principles of good laboratory practice (GLP), which is, according to REACH Article 13 (4), required for toxicological tests. The study has been conducted according to the standard guideline(s) with some (minor) deviations. It was conducted in a facility operating to GLP within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study. However it has been declared by the study director that the report is an accurate record of the study and its outcome. The original data are retained in the archives of the test facility. The analytical characterisation of the test material has been performed according to GLP.
After assessing all information on this study, the registrant has concluded that the following conditions are met:
(1) adequacy for the purpose of classification and labelling and/or risk assessment;
(2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3);
(3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and
(4) adequate and reliable documentation of the study is provided.
Thus, according to REACH Annex XI, 1.1 ("Testing does not appear scientifically necessary - Use of existing data"), these existing data are considered to be acceptable for fulfilling the information requirements of this endpoint. As a consequence, the overall reliability rating (according to Klimisch et al.) is considered to be between "reliable with restrictions" and "not reliable", but closer to "reliable with restrictions". Thus a Klimisch rating of 2 (reliable with restrictions) has been assigned. - Executive summary:
An in vivo study for eye irritation (OECD 405, rabbit) has been conducted. Based on its results, the test item is a mild irritant (class 4 on a 1-8 scale) according to Draize Scale for Scoring Ocular Irritation and Modified Kay and Calandra Interpretation of Eye Irritation Test.
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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