Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 904-919-6 | 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
- Study period:
- 24 April 2001 - 16 May 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The in vivo test was performed before the REACH regulation came into force, requesting in vitro studies.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [1S-(1α,3aβ,4α,8aβ)]-decahydro-4,8,8-trimethyl-9-methylene-1,4-methanoazulene
- EC Number:
- 207-491-2
- EC Name:
- [1S-(1α,3aβ,4α,8aβ)]-decahydro-4,8,8-trimethyl-9-methylene-1,4-methanoazulene
- Cas Number:
- 475-20-7
- Molecular formula:
- C15H24
- IUPAC Name:
- (1S,3aR,4S,8aS)-4,8,8-trimethyl-9-methylidenedecahydro-1,4-methanoazulene
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst).
- Water: Free access to community tap water from Füllinsdorf
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 14
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE:
Four days before treatment, the left flank was was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10x10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped.
TREATMENT
On the day of treatment, 0.5 mL of the test substance was places on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to approx. 6 square centimeters of the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and enchored with tape.
REMOVAL OF TEST SUBSTANCE
After 4 hours the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.
OBSERVATIONS
- Mortality/Viability and Clinical signs: Daily from delivery of the animals to the termination of the test.
- Body Weight: At the start of acclimatization, on the day of application and at termination of observation.
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and at 7, 10 and 14 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.
If evident, corrosive or staining properties of the test substance were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- At 1 hour, in one animal moderate erythema was seen; at the same time in 2/3 severe swelling was seen. At 24/48/72 hours well-defined erythema were seen in all animals with maximum score 2; at this time point 2/3 animals showed moderate to severe swelling with average score of 2.33 and one animal scored 1.33. All skin reactions were clear 14 days after treatment.
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Scaling was evident at the test site of all animals from 7 to 10 days after treatment. In addition, the skin of one female was noted to be dry and inelastic at these readings.
No staining by the test substance of the treated skin was observed. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
The body weights of all animals were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant Cat 2
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its updates.
- Conclusions:
- In this skin irritation study with rabbits, performed according to OECD 404 guideline and GLP principles, moderate erythema (score 2) were seen and moderate to severe edema (score 1-3) were seen at 24/48 and 72hours. Two out of three animals have an average edema score of = 2.33, while the other animal scored an average of 1.33. The irritant effects were reversible within 14 days. This means that the substance is a skin irritant.
- Executive summary:
The substance was tested for 4 hours in a skin irritation test in 3 rabbits according to OECD TG 404 test guideline and GLP principles.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. In this study moderate erythema (score 2) were seen and moderate to severe edema (score 1 -3) were seen at 24/48 and 72hours. Two out of three animals have an average edema score of = 2.33, while the other animal scored average of 1.33 for edema. The irritant effects were reversible within 14 days. This means that the substance is a skin irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.