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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 224-314-4 | CAS number: 4303-67-7
- 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:
- 24 March 2009 to 22 April 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP (1997) and OECD Guideline 429 (2002).
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:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- MTDID 13999
- IUPAC Name:
- MTDID 13999
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 13999
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: 100%
- Purity test date: 09 February 2009
- Lot/batch No.: Batch 338724
- Expiration date of the lot/batch: 27 August 2011
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, NL-5960 AD Hortst/The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 17.8-21.7
- Housing: Group housed
- Diet (e.g. ad libitum): Pelleted standard diet (Harlan Laboratories GmbH, D-33178 Borchen) ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 March 2009 To: 22 April 2009
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0 (control), 1, 2.5, and 5.0 % test substance in vehicle
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice as indicated by the simulation index. The data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by epidermal application to the dorsal surface of each ear lobe (left and right) with 25 uL of the appropriate test item concentration. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control results were as expected, indicating the test method was valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Simulation Index relative to the mean of the control group: 1%: 2.9-5.7 2.5%: 9.7-14.7 5.0%: 12.8-17.7
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control: 461-1172 1%: 2162-4291 2.5%: 7308-10996 5.0%: 9568-12187
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Category 1A Skin Sensitizer Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study and CLP classification criteria, the test article is Category 1A skin sensitizer.
- Executive summary:
The dermal sensitizing potential of the test article (colorless liquid, purity 100% CASRN 4303-67-7, batch 338724) was evaluated in a local lymph node assay (LLNA) in female CBA mice. This study was performed in compliance with the Chemicals Act of Germany (2002) and OECD GLP (1997). The study design was based on OECD Guideline 429 (2002). The test article was diluted in vehicle (Acetone/Olive Oil at 4:1 (v/v)) for the appropriate concentrations. A pre-test evaluated 10 and 25% test article on the ear of one mouse mice each for three consecutive days. Treatment with 25% or 10% led to the deaths of both mice after 3 days (25% test article) and 7 days (10% test article). Unintended ingestion following grooming was considered a possible source of the mortality given the known rat acute oral LD50 (641 mg/kg). A second pre-test evaluated 2.5 and 5% test article for three consecutive days on one mouse each. The animals in the second pre-test did not show signs of irritation or systemic toxicity. Groups of animals (5/treatment) received vehicle, 1, 2.5 or 5% test article on three consecutive days by application on the ears. Three days after the last exposure all animals were subjected to a 3H-methyl thymidine treatment and the auricular lymph nodes were removed to measure the amount of proliferative DNA by disintegrations per minute (DPM). The stimulation index (SI) was calculated for each group and, if possible, the concentration at which the test article could elicit an SI greater than or equal to 3 was determined (EC3). Hexylcinnamic aldehyde (HCA) is tested in this study design every 6 months at the test facility as a positive control and the most recent results indicated that model was valid. Mean DPM/animal values were 1622.5, 4533.7, and 5609.6 for the 1, 2.5 and 5% test article groups, respectively. The mean DPM/animal value for the vehicle control group was 374.9. The SI values for the 1, 2.5 and 5% test article groups were 4.33, 12.09, and 14.96, respectively. The EC3 could not be calculated because all SI were > 3. However, the EC3 is clearly less than 2%, because 1% CASRN 4303-67-7 produced an SI value of 4.33 . Based on the results of this study, the test article is a dermal sensitizer.
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.