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Diss Factsheets
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EC number: 470-740-0 | CAS number: 29721-79-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Feb to 1 march, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Done by OECD and GLP standards
Data source
Reference
- Reference Type:
- other: Unnamed report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- At the start of the study the mice were in the weight range of 15 to 23 grams and were8 to 12 weeks old. Animlas were acclimatised for 5 days prior to the study. Free access to mains drinking water and food was allowed through out the study. The temperature and relative humidity were set to achieve limits of 19 to 25 C and 30 to 70% respectively. The lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- test material at concentrations of 25% & 50% in acetone/olive oil and 100% w/w.
- No. of animals per dose:
- Three groups of four animals each were treated at each concentration group and a further group of five animals were treated as a control group with acetone/olive oil alone.
- Details on study design:
- The mice were treated by daily application of 25 μl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3) by using a micropipette whose tip is used to spread the formulation over the dorsal surface of each ear. On Day 6 all mice were injected with 250 ul of a phophate buffered saline solution containing 3H-methyl thymidine (3HTdR ) to the tail vein giving a total of 20 uCi to each mouse. All animals were observed twice daily on Day 1, 2 and 3 and once daily on days 4 ,5, and 6. Any signs of toxicity or ill health were noted. Body weights of each mouse were recorded before dosing and before termination. Five hours after administration of 3HTdR all mice were killed by carbon dioxide asphyxiation and their auricular lymph nodes were excised and a 1 ml of phosphate buffered saline was added to each set of lymph nodes. Preparation of a single cell suspension was completed for the lymph nodes cells for each individual animal following standard procedures. Determination of the 3HTdR incorporation was completed by measuring radioactive disintegration for each animal's lymph node cells by using a beta-scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Considered positve for skin sentization.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 25 % resulted in a stimulation index (SI) of 1.16 which is a negative result.Concentration of test material in the vehicle at 50 % resulted in a stimulation index (SI) of 1.83 which is a negative result.Concentration of test material at 100% resulted in a stimulation index (SI) of 0.61 which is a negative result. A stimulation index of less than 3 was recorded for the three concentrations of the test material.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration of test material in the vehicle at 25 % resulted in a mean disintegration of 122254.42 dpm which is a negative result.Concentration of test material in the vehicle at 50 % resulted in a mean disintegration of 19373.89 dpm which is a negative result. Concentration of test material at 100 % resulted in a mean disintegration of 6496.02 dpm which is a negative result. The results of the statistical analysis of the data indicated there was no significant difference between the control group and the test groups.
- Parameter:
- SI
- Remarks:
- (SI) of 1.16 which is a negative result.Concentration of test material in the vehicle at 50 % resulted in a stimulation index
- Value:
- ca. 1.16
- Test group / Remarks:
- 25% concentration
- Remarks on result:
- other:
- Remarks:
- Concentration of test material in the vehicle at 25 % resulted in a stimulation index (SI) of 1.16 which is a negative result.
- Parameter:
- SI
- Remarks:
- (SI) of 1.83 which is a negative result.Concentration of test material at 100% resulted in a stimulation index
- Value:
- ca. 1.83
- Test group / Remarks:
- 50% concentration
- Remarks on result:
- other:
- Remarks:
- Concentration of test material in the vehicle at 50 % resulted in a stimulation index (SI) of 1.83 which is a negative result.
- Parameter:
- SI
- Value:
- ca. 0.61
- Test group / Remarks:
- 100% concentration
- Remarks on result:
- other:
- Remarks:
- Concentration of test material at 100% resulted in a stimulation index (SI) of 0.61 which is a negative result. A stimulation index of less than 3 was recorded for the three concentrations of the test material.
Any other information on results incl. tables
There were no deaths. No signs of systemic toxicity were noted in the test or control animals
during the test. Body weight chnages of the test animals between day 1 to day 6 were comparable to body weight changes of the control animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be non-sensitising under conditions of the 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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