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EC number: 941-628-3 | CAS number: 1263184-87-7
- 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
- Remarks:
- This study was conducted solely to comply with a non-EU national registration requirement.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Mar 2014 to 16 Mar 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- rac-(1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- EC Number:
- 941-628-3
- Cas Number:
- 1263184-87-7
- Molecular formula:
- C12H14Cl2O2
- IUPAC Name:
- rac-(1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 12 weeks
- Weight at study initiation: 2979 – 3262 g
- Housing: Animals were housed individually in AAALAC approved metal wire rabbit cages. Cages are of an open wire structure and cages are placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 26 Feb to 10/12 Mar 2014
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 24-48
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
11 Mar 2014 to 16 Mar 2014
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- (moistened with a small amount of water)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g of the test substance (moistened with small amount of water) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: This gauze pad was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was then wrapped with plastic wrap held in place with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Clinical signs, including viability/mortality, were recorded daily from the day of application of the animals to the termination of the test.
- Body weights were recorded on the day of application and the end of the experiment.
SCORING SYSTEM:
- Method of calculation: Draize scoring system. The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after the end of exposure (removal of the dressing, gauze patch and test item). The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The Cumulative Scores for the Skin Irritation Scores were calculated and represent the sum of all numerical scores for each animal at each time point. The resulting Mean Cumulative Skin Irritation Score was calculated for all animals at each time point.
The Primary Irritation Index (P.I.I.) was calculated by totalling the mean cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. Skin irritation was scored based on the grading system presented in 'Any other information on materials methods incl. tables'.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary irritation index was 0.00 (out of a maximum score of 8.0). No corrosive effects were noted on the treated skin of any animal at any of the observation intervals.
No local dermal signs were observed in the treated animals throughout the study. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Table 1. Skin Irritation Scores - Mean Values After 24, 48 and 72 Hours
Animal Number |
Sex |
Erythema |
N |
Oedema |
N |
Primary Skin Irritation Index |
00840 |
male |
0.00 |
3 |
0.00 |
3 |
0.00 |
00870 |
male |
0.00 |
3 |
0.00 |
3 |
|
00842 |
male |
0.00 |
3 |
0.00 |
3 |
|
Mean score |
0.00 |
0.00 |
|
|||
N= number of available data points. |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test substance did not result in any signs of skin irritation. According to the Draize classification criteria, the test substance is considered to be “not irritant” to rabbit skin.
- Executive summary:
In this GLP compliant, OECD 404 study, the primary skin irritation potential of the test substance was investigated using 3 young adult New Zealand White rabbits. The animals were treated by topical, semi-occlusive application of 0.5 g to their intact shaved flanks. The duration of treatment was 4 hours. The scoring of skin reactions was performed at 1, 24, 48 and 72 hours after removal of the dressing. The primary irritation index (P.I.I.) was calculated by totalling the mean cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points.
The primary irritation index was 0.00. No local dermal signs were observed in the treated animals throughout the study. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hour observation. The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test substance did not result in any signs of skin irritation. According to the Draize classification criteria, the test substance is considered to be “not irritant” to rabbit skin (P.I.I. = 0.00).
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