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EC number: 204-574-5 | CAS number: 122-78-1
- 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
Skin sensitisation (OECD 429): sensitising
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6-12 weeks
- Housing: under standard conditions
- Diet: ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
No further data - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Test substance and positive control: 1, 2.5, 5, 10, 25 and 50%
- No. of animals per dose:
- 4
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: A stimulation index (SI) relative to the concurrent vehicle treated control value was calculated for each group. The criterion for a positve response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance daily for 3 consecutive days. Five days after initiation of exposure an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (³HTdR) was made into the tail vein of each experimental mouse. Five hours later, following injection of ³HTdR, the mice were sacrificed and draining auricular lymph nodes were excised and pooled for each experimental group. A single cell suspension was prepared by gentle separation through a 200 mesh stainless steel gauze. The cell suspensions were washed two times with an excess of PBS and precipitated with 5% trichloroacetic acid at 4 °C for 12 h. The pellets were resuspended in 1 mL of 5% trichloroacetic acid and transferred to 10 mL of scintillation fluid. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC3 value was calculated by interpolating between 2 points on the SI axis, one immediately above, and the other immediately below, the SI value of 3. The vehicle-treated control (SI=1) cannot be used for the latter. Where the data points lying immediately above and below the SI value of 3 have the co-ordinates (a, b) and (c, d) respectively, then the EC3 value may be calculated using the following equation: EC3 = c + [(3 - d)/(b - d)] × (a - c)
- Positive control results:
- The EC3 value calculated for the positive control was 14.7.
- Key result
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- 1% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 1.76
- Test group / Remarks:
- 2.5% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 7.84
- Test group / Remarks:
- 5% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 8.76
- Test group / Remarks:
- 10% (w/v)
- Key result
- Parameter:
- SI
- Value:
- 18.96
- Test group / Remarks:
- 25% (w/v)
- Key result
- Parameter:
- EC3
- Value:
- 3
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 185
- Test group / Remarks:
- 1% (w/v)
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 450
- Test group / Remarks:
- 2.5% (w/v)
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 000
- Test group / Remarks:
- 5% (w/v)
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 233
- Test group / Remarks:
- 10% (w/v)
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 4 834
- Test group / Remarks:
- 25% (w/v)
- Interpretation of results:
- other: Skin Sens Cat 1B is required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the mouse Local Lymph Node Assay the test substance revealed a SI ≥ 3.0 at concentrations of 5, 10 and 25%. The EC3 value was 3.0%. Therefore, the test substance is considered as a moderate sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitising potential of the test substance was evaluated in a LLNA test according to OECD 429 (2001).The study was conducted on four female mice per dose group (1, 2.5, 5, 10 and 25% w/v). Each animal received 25 µL of the substance to the dorsum of each ear. Animals were treated once daily for three consecutive days. Five days after initiation of exposure, all animals were injected with tritiated methyl-thymidine in the tail vein. Five hours later, animals were sacrificed, and the draining auricular lymph nodes removed and prepared for cell suspension and scintillation counting. A vehicle control (4:1 v/v acetone:olive oil) group was run concurrently. The test substance produced stimulation indices of 0.73, 1.76, 7.84, 8.76 and 18.96 at concentrations of 1, 2.5, 5, 10 and 25% (w/v) in 4:1 v/v acetone:olive oil, respectively and a EC3 value of 3.0% was calculated. Therefore the test substance was considered to be a moderate sensitiser.
Two additional publications are available (Klecak et al., 1977 and Ryan et al., 2000; not included as robust study summary in IUCLID) showing sensitising properties of the test substance. Klecak et al. summarises four different studies in guinea pigs (open epicutaneous test, Draize test, maximisation test and an intradermal test with Freund´s complete adjuvant) all showing sensitising properties of the test substance at different concentrations and undiluted, repectively (1977). In the OET a minimum sensitizing concentration of 0.3% and a minimum eliciting concentration of 0.03% were determined. Ryan et al. showed sensitising properties of the test substance in an murine local lymph node assay where stimulation indices of > 3 were produced at all tested concentrations (25, 50 and 100% (w/v) in acetone:olive oil) (2000).
In conclusion, the test substance is considered to be a weak skin sensitiser with regard to the criteria of the CLP regulation (Skin Sens. 1B).
References:
Klecak, G. et al. (1977): Screening of fragrance materials for allergenicity in the guinea pig. Journal of the Society of Cosmetic Chemists, Vol. 28, pp. 53 - 64
Ryan, C. A. et al. (2000): Activity of human contact allergens in the murine local lymph node assay. Contact Dermatitis, Vol. 43, pp. 95 - 102
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the test substance meet the criteria for classification as Skin Sens 1B (H317) according to Regulation (EC) No 1272/2008.
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