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EC number: 600-065-0 | CAS number: 1003218-40-3
- 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
A study according to OECD TG 429 was performed with a structural analogue substance on guinea-pigs. No skin sensitization was reported (reference 7.4.1 -1).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-07-11 to 2003-10-13
- 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:
- adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 17.6 - 25.0 g
- Housing: groups of 4
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 5 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- pre-test for irritation: 1, 2.5, 5 and 10 % (w/v)
main test: 2.5, 5 and 10 % (w/v) - No. of animals per dose:
- pre test: 2
main test: 4 (f) per group (3 test groups, 1 control group) total 16 (f) - Details on study design:
- RANGE FINDING TESTS:
In a non-GLP conform pre-test in two mice, test item concentrations of 1 %, 2.5 %, 5 % and 10 % (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application. 10 % (w/v) was the highest technically achievable concentration in the chosen vehicle.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD TG 429
- Criteria used to consider a positive response: A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
- First, that 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 stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
- Topical application of 25 µL test item preparation (test group) or vehicle (control group)
- five days after topical application: iv application of 3H-methyl thymidine
- five hours after treatment with 3H-methyl thymidine, necropsy and analysis of the 3H thymidine incorporation in draining lymph nodes - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Dunnets Test
- Positive control results:
- alpha-hexylcinnamaldehyde:
5% : S.I=1.5
10%: S.I.=3.2
25%: S.I.=6.9 - Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Test Group 2.5 %
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- Test Group: 5 %
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Test Group: 10 %
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not a skin sensitiser under the described conditions in this assay.
- Executive summary:
A LLNA study according to OECD 429 was performed in order to study a possible contact allergenic potential of the test material, three groups each of four female mice were treated daily with the test item at concentrations of 2.5, 5 and 10 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. 10 % was the highest technically achievable concentration in the vehicle.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 2., 2.3 and 2.0 were determined with the test item at concentrations of 2.5, 5, and 10 % in acetone:olive oil, 4:1 (v/v), respectively.
The test material was found to be not a skin sensitiser up to the highest technically achievable concentration of 10 % in the selected vehicle.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For this endpoint information from structural similar compounds is available. The studies for these similar compounds were performed according to GLP and the methods applied are fully compliant with OECD TG 429. See chapter 13 report for a more detailed justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Test group 2.5 %
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- Test group 5 %
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Test group 10 %
- 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
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A LLNA study according to OECD 429 was performed with the structural analogue substance in order to study a possible contact allergenic potential of the test material, three groups each of four female mice were treated daily with the test item at concentrations of 2.5, 5 and 10 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. 10 % was the highest technically achievable concentration in the vehicle.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 2., 2.3 and 2.0 were determined with the test item at concentrations of 2.5, 5, and 10 % in acetone:olive oil, 4:1 (v/v), respectively.
The test material was found to be not a skin sensitiser up to the highest technically achievable concentration of 10 % in the selected vehicle.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this information, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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