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EC number: 618-440-2 | CAS number: 900796-46-5
- 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
Endpoint summary
Administrative data
Description of key information
The information for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 429. The compound was not a skin senstiser under the conditions of this assay.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-05-15 to 2007-05-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 04-2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands B.V., NL 5960 AD Horst
- Age: 7-8 weeks at beginning of acclimatisation
- Weight at study initiation: 17.4 - 20 g
- Housing: single in Makrolon type-1 cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not further specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-88
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Days 1 - 5 - Vehicle:
- dimethylformamide
- Concentration:
- pre test for signs of irritation: 2.5, 5, 10 and 25 %
main test: 5, 10 and 25 % - No. of animals per dose:
- pre test: 2 f
main test: 5 f per group (3 test groups, 1 control group) - Details on study design:
- RANGE FINDING TESTS
To determine the highest non-irritant test concentration or the highest technically applicable concentration, a pretest was performed in two mice with test item concentrations of 2.5, 5, 10 and 25 % on one ear each. No irritation effects were observed at these concentrations after a single application.
MAIN STUDY
Criteria used to consider a positive response: 3-fold greater response at one concentration in SI than control animals
TREATMENT PREPARATION AND ADMINISTRATION
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 5, 10 and 25% (w/v) in dimethylformamide. The application volume of 25 uL was spread over the entire dorsal surface (0 - 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application, all mice were administered with 250 uL of 78.8 uCi/mL 3H-methyl thymidine (3HTdR) by intravenous injection via a tail vein. Prior to the first application of the test item and prior to treatment with 3HTdR the ear thickness was determined using a micrometre.
The level of 3HTdR incorporation was then measured on a ß-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 mL-aliquots of 5 % trichloroacetic acid. The ß-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
The validation/positive control experiment was performed with alpha-Hexylcinnamaldehyde in acetone:olive oil (4+1) in mice. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations were calculated in the body weight tables. A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation EC3 = (a-c) [(3-d)/(b-d)] + c, where EC3 is the estimated concentration of the test item required to produce a 3-fold
increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 3 on the local lymph node assay dose response plot. - Positive control results:
- Conc. (%, w/v) SI
5 1.03
10 1.59
25 1.68 - Key result
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.68
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- EC3
- Remarks:
- % (w/v)
- Remarks on result:
- not determinable
- Remarks:
- All SI were < 3
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not a skin sensitiser in this assay.
- Executive summary:
Study Design
The test item dissolved in dimethylformamide was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25%. The GLP study was performed according to OECD TG 429.
Results
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. The ear thickness was not affected by the treatment with the test item. Stimulation Indices (S.I.) of 1.03, 1.59, and 1.68 were determined with the test item at concentrations of 5, 10, and 25% in dimethylformamide, respectively.
Conclusion
The test item was not a skin sensitiser in this assay.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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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