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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
![](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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2011-01-04 - 2011-01-18 (experimental phase)
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study provides some useful information about the properties of the test item. However it has been conducted only at a screening level. No specific reference to a guideline is given in the study report. However it is assumed that the study design has been based on the main principles of a corresponding relevant guideline and that the study did not follow the corresponding guideline in detail. The level of information collected/reported is limited. In addition the study has not been performed according to GLP. As a consequence the reliability ("evaluating the inherent quality of a test report or publication relating to preferably standardized methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings"), relevance ("covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterization") and adequacy ("defining the usefulness of data for hazard/risk assessment purposes") of the data ("data quality") are considered as limited and an overall reliability rating of 3 (= not reliable, according to the scoring system of Klimisch et al.) has been assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was assessed for its skin sensitising potential using the Local Lymph Node Assay in the CBA/Ca strain of mouse, according to a general study plan of the test facility. The test is designed to assess the skin sensitising potential (delayed type hypersensitivity) of the test item following topical application to the dorsal surface of the ear. Primary lymphocyte proliferation is assessed during the sensitising (induction) phase of the response.
The assay determines the level of lymphocyte proliferation in lymph nodes draining the application site of the test item. Determination of lymphocyte proliferation is quantified by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). - 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.
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25 % w/w
- No. of animals per dose:
- 4
- Details on study design:
- Following a preliminary screening test, a group of four animals was treated with 50 μl (25 μl per ear) of the test item as a solution in dimethyl formamide at a concentration of 25% w/w. A further group of four animals was treated with dimethyl formamide alone.
Results and discussion
- Positive control results:
- not applicable (no positive controls used in study)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Stimulation index: 1.72 (negative) The Stimulation Index is expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group. A positive result is obtained if the stimulation index is greater than 3.0.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 3 in "Any other information on results incl. tables"
Any other information on results incl. tables
Clinical observations, bodyweight and mortality data for the preliminary screening test are given in Table 1. The ear thickness measurements and mean ear thickness changes for the preliminary screening test are given in Table 2. The radioactive disintegrations per minute (dpm) per lymph node and the Stimulation Index for the main test are given in Table 3. Individual clinical observations and mortality data for the main test are given in Table 4 and individual bodyweights are given in Table 5.
Table 1: Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (% w/w) in dimethyl formamide | Bodyweight (g) | Day | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | ||||||||
Animal Number | Day 1 | Day 6 | Pre-Dose | Post Dose | Pre-Dose | Post Dose | Pre-Dose | Post Dose | |||||
25 | S-1 | 20 | 19 | 0 | 0 | 0 | 0Rt | 0 | 0Rt | 0Rt | 0Rt | 0Rt |
0 = No signs of systemic toxicity
Rt = Off white residual test item on the ears
Table 2: Measurement of Ear Thickness and Mean Ear Thickness Changes – Preliminary Screening Test
Concentration (% w/w) in dimethyl formamide | Animal Number | Ear Thickness Measurement (mm) | |||||||||||
Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | ||||||||
pre-dose | post dose | post dose | |||||||||||
left | right | left | right | left | right | left | right | left | right | left | right | ||
25 | S-1 | 0.220 | 0.225 | 0.260 | 0.240 | 0.270 | 0.245 | 0.235 | 0.230 | 0.240 | 0.240 | 0.250 | 0.245 |
overall mean (mm) | 0.223 | 0.250 | 0.258 | 0.233 | 0.240 | 0.248 | |||||||
overall mean ear thickness change (%) | na | 12.360 | 15.730 | 4.494 | 7.87 | 11.236 |
na = Not applicable
Table 3: Dpm, Dpm/Node and Stimulation Index
Concentration (% w/w) in dimethyl formamide | Dpm | Dpm/Node §a | Stimulation Index §b | Result |
Vehicle | 984.24 | 123.03 | na | na |
25 | 1694.18 | 211.77 | 1.72 | Negative |
§a = Dpm/node obtained by dividing the Dpm value by 8 (total number of lymph nodes)
§b = Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Table 4: Individual Clinical Observations and Mortality Data
Concentration (% w/w) in dimethyl formamide | Animal Number | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | |||
Pre-Dose | Post Dose | Pre-Dose | Post Dose | Pre-Dose | Post Dose | |||||
Vehicle | 1-1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vehicle | 1-2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vehicle | 1-3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vehicle | 1-4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
25 | 2-1 | 0 | 0Rt | 0 | 0Rt | 0 | 0Rt | 0 | 0 | 0 |
25 | 2-2 | 0 | 0Rt | 0 | 0Rt | 0 | 0Rt | 0Rt | 0Rt | 0Rt |
25 | 2-3 | 0 | 0Rt | 0 | 0Rt | 0 | 0Rt | 0Rt | 0Rt | 0Rt |
25 | 2-4 | 0 | 0Rt | 0 | 0Rt | 0 | 0Rt | 0Rt | 0Rt | 0Rt |
0 = No signs of systemic toxicity
Rt = Off white residual test item on the ears
Table 5: Individual Bodyweights and Bodyweight Changes
Concentration (% w/w) in dimethyl formamide | Animal Number | Bodyweight (g) | Bodyweight Change (g) | |
Day 1 | Day 6 | |||
Vehicle | 1-1 | 18 | 17 | -1 |
Vehicle | 1-2 | 21 | 21 | 0 |
Vehicle | 1-3 | 17 | 17 | 0 |
Vehicle | 1-4 | 18 | 19 | 1 |
25 | 2-1 | 22 | 22 | 0 |
25 | 2-2 | 20 | 20 | 0 |
25 | 2-3 | 21 | 20 | -1 |
25 | 2-4 | 22 | 21 | -1 |
Applicant's summary and conclusion
- Interpretation of results:
- other: see Conclusions below
- Conclusions:
- This study provides some useful information about the properties of the test item. However it has been conducted only at a screening level. No specific reference to a guideline is given in the study report. However it is assumed that the study design has been based on the main principles of a corresponding relevant guideline and that the study did not follow the corresponding guideline in detail. The level of information collected/reported is limited. In addition the study has not been performed according to GLP.
As a consequence the reliability ("evaluating the inherent quality of a test report or publication relating to preferably standardized methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings"), relevance ("covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterization") and adequacy ("defining the usefulness of data for hazard/risk assessment purposes") of the data ("data quality") are considered as limited and an overall reliability rating of 3 (= not reliable, according to the scoring system of Klimisch et al.) has been assigned. - Executive summary:
A screening level in vivo study for skin sensitisation has been conducted (Local Lymph Node Assay (LLNA) in the mouse). The test item was considered to be a non-sensitiser under the conditions of the test.
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