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EC number: 946-937-7 | 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:
- 07 August 2009 to 20 October 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China).
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Not specified
Test material
- Reference substance name:
- 2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate
- EC Number:
- 946-937-7
- Molecular formula:
- C36H62N2O8
- IUPAC Name:
- 2,2-bis[(allyloxy)methyl]butyl (3-{[({2,2-bis[(allyloxy)methyl]butoxy}carbonyl)amino]methyl}-3,5,5-trimethylcyclohexyl)carbamate
- Test material form:
- liquid
- Details on test material:
- - Storage: cool and dark
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: adults
- Acclimation period: 5 days prior to the test
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24°C
- Humidity: 50 to 70%
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 4 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm^2 area on the scapular to lumbar region of the back.
- Type of wrap if used: The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours, coverings were removed and the application sites were rinsed completely with warm water.
OBSERVATION TIME POINTS
Animals were observed continually for 14 days, Skin irritation was evaluated at approximately 1, 24, 48 and 72 hoursr after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity.
SCORING SYSTEM:
The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Other effects:
- Individual skin irritation scores are presented in Table 1. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0.
Any other information on results incl. tables
Table 1: Skin irritation scores
Animal No. |
Position |
Skin Irritation scores |
|||||||
1 h |
24 h |
48 h |
72 h |
||||||
R |
L |
R |
L |
R |
L |
R |
L |
||
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was determined to be non-irritating to the skin.
- Executive summary:
The skin irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). The test material was administered to a 2 x 3 cm2 area on the scapular to lumbar region of the back that had been shaved on the previous day. The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape. After 4 hours, coverings were removed and the application sites were rinsed completely with warm water. Animals were observed continually for 14 days. Skin irritation was evaluated at approximately 1, 24, 48 and 72 hours after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0. Under the conditions of this study, the test material was considered to be non-irritating to the skin.
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