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EC number: 466-490-7 | CAS number: -
- 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
FAT 40827 was found to be a skin sensitizer.
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:
- Experiment start date - 10 May 2006; Experiment completion date - 24 May 2006; Study completion date - 15 June 2006.
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaHsdRcc(SPF);
Number of animals for the pre-test: 3 females;
Number of animals for the main study: 16 females;
Number of animals per group: 4 females (nulliparous and non-pregnant);
Age: 8-12 weeks (beginning of acclimatization);
Body weight: 16-24 g;
Identification: Each cage by unique cage card;
Randomization: Randomly selected by computer algorithm at time of delivery.
Acclimatization: Under laboratory conditions after health examination. Only healthy animals were used for the study.
Conditions
Standard Laboratory Conditions.
Air-conditioned with ranges for room temperature of 22 ± 3 °C and relative humidity 30-70 % and approximately 10-15 air changes per hour. There was a 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation: Individual in Makrolon type-2 cages with standard softwood bedding.
Diet: Pelleted standard Provimi Kliba 3433 mouse maintenance diet (batch 001/06) ad libitum.
Water: Community tap water, ad libitum. - Vehicle:
- dimethylformamide
- Concentration:
- 2.5 %, 5 % and 10 % in 25 µl of DMF
- No. of animals per dose:
- 4
- Details on study design:
- Three groups each of four female mice were treated daily with the test item at concentration of 2.5 %, 5 % and 10 % in DMF by topical application to the dorsum of each ear lobe for three consecutive days. Five days after the first topical application, the mice were injected intravenously into a tail vein with radiolabelled thymidine (³H-methyl thymidine, ³HTdR). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of ³HTdR measured in a ß–scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
- Positive control results:
- S.I. of 1.8, 2.9 and 6.2 of determined with alpha-hexylcinnamaldehydewere at concentrations of 5 %, 10 % and 25 %, respectively, in acetone: olive oil, 4:1 (v/v). Alpha-hexylcinnamaldehyde was therefore found to be a skin sensitizer in the LLNA tests and an EC3 value of 10.5 % was derived.
- Parameter:
- SI
- Value:
- 10.9
- Test group / Remarks:
- 2.5 %
- Parameter:
- SI
- Value:
- 16.8
- Test group / Remarks:
- 5 %
- Parameter:
- SI
- Value:
- 23
- Test group / Remarks:
- 10 %
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- S.I. of 10.9, 16.8 and 23.0 were determined with the test item at concentrations of 2.5 %, 5 % and 10 %, respectively, in DMF and the test item was therefore found to be a potential skin sensitizer in the LLNA tests.
- Executive summary:
In a GLP compliant study conducted according to OECD test guideline 429, three groups each of four female mice were treated daily with the test item at concentration of 2.5 %, 5 % and 10 % in DMF by topical application to the dorsum of each ear lobe for three consecutive days. Five days after the first topical application, the mice were injected intravenously into a tail vein with radiolabelled thymidine (3H-methyl thymidine, 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3HTdR measured in a ß–scintillation counter. All treated animals survived the scheduled study period. No clinical signs were observed. After the first topical application, the dark red stain was found at both dosing sites in all mice of the test item group, persisting for the remainder of the in-life phase of the study. In the study, S.I. of 10.9, 16.8 and 23.0 were determined with the test item at concentrations of 2.5 %, 5 % and 10 %, respectively, in DMF. The EC3 value cannot be determined, since this calculation requires a S.I. values less than 3. Although according to the data reported above, the EC3 can be derived to be <1 %, thus, the substances shows a high sensitizing potential. Based on these results, the substance is to be classified as Skin Sensitizer category 1A according to the CLP regulation (Regulation EC No. 1272/2008 as amended).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
This skin sensitization study was performed according to OECD Guideline 429 under GLP conditions. Three groups each of four female mice were treated daily with the test item at concentration of 2.5 %, 5 % and 10 % in DMF by topical application to the dorsum of each ear lobe for three consecutive days. All treated animals survived the scheduled study period. No clinical signs were observed. After the first topical application, the dark red stain was found at both dosing sites in all mice of the test item groups., persisting for the remainder of the in-life phase of the study. In the study, S.I. of 10.9, 16.8 and 23.0 were determined with the test item at concentrations of 2.5 %, 5 % and 10 %, respectively, in DMF. The test item was therefore found to be a potential skin sensitizer in the LLNA test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substance shall be classified as Category 1A according to the CLP regulation (Regulation EC No. 1272/2008). Data on respiratory irritation are lacking.
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