Registration Dossier
Registration Dossier
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: 700-427-9 | 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
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:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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
- Source: Velaz s.r.o., Lysolaje 15, 165 00 Praha 6
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18-20 g
- Housing: the animals were housed individually in plastic cages T I
- Diet (e.g. ad libitum): ad libitum, the animals were given standard fodder MP (TOP DOVO)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: qnimals were quarantined before the start of the experiement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- the test item was administered at 10, 25 and 50% concentrations
- No. of animals per dose:
- 5 animals per dose
- Details on study design:
- RANGE FINDING TESTS: range finding test was not performed.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: pooled approach
- Criteria used to consider a positive response: SI ≥ 3 and dose dependece of increase in lymph node weight and in DPM
TREATMENT PREPARATION AND ADMINISTRATION:
On day 1 the dorsum of each ear of each animal was treated with 25 µl of appropriate dilution of the test item, positive control or vehicle only. The treatment was repeated on days 2 and 3. No treatment was performed on days 4 and 5. On day 6 250 µl of phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later the animals were sacrificed. The draining Auricular lymph node of each ear was excised into PBS for each experimental group and weighted.
Cell suspension of lymph node cells from pooled treatment groups was prepared by gentle mechanical desagregation in glass homogenizer. lymph node cells were washed with an excess of PBS and centrifuged by 600 g at 4 °C for 10 min. Suspension of cells was precipitated with 5 % trichloroacetic acid (TCA) at 4 °C for 18-20 hrs. Pellets were centrifuged by 2000 g at 4 °C for 5 min., re-suspended in 1 ml TCA and transferred into scintillation vials containing 10 ml of scintillation fluid for 3H-counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Parameter:
- SI
- Remarks on result:
- other: Pos. Control 4.46 Atlen SK 10% 2.87 Atlen SK 25% 3.13 Atlen SK 50% 4.18
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Control 1067.21 Pos. Control 4760.68 Atlen SK 10% 3084.38 Atlen SK 25% 3342.82 Atlen SK 50% 4487.57
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Results of the LLNA study indicate that Atlen SK is a skin sensitiser.
- Executive summary:
Presented results originate from a guideline study conducted in accordance with the requirements of the GLP. Hence, this information can be considered reliable and suitable for use as the key study for this endpoint.
Reference
EC3 calculated on the basis of the aforementioned results amounted to 17.5% (moderate sensitizer).
According to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health:
LOAEL = EC3 [%]*250 [μg/cm2/% ] = EC3 [μg/cm2]
Calculated LOAEL: 4375 μg/cm2
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitising potential of Atlen SK was tested in vivo.
Atlen SK was tested in LLNA study on mice at concentrations 10, 25 and 50%. Statistically significant and dose dependend increase in the lymph node weight and number of measured disintegrations per second was found. This indicated that Atlen SK was positive in the test.
EC3 value obtained in this test (17.5%) was converted to μg/cm2 using the equation given in the document 'Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health' (May 2008, p. 128) in order to obtain the LOAEL value. The obtained LOAEL value of 4375 μg/cm2 was next used as the key value in the Chemical Safety Assessment.
Migrated from Short description of key information:
Atlen SK was found to be a skin sensitizer in LLNA test.
Justification for selection of skin sensitisation endpoint:
One study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Evaluation of this endpoint is not required under REACH.
Justification for classification or non-classification
Available data is conclusive and sufficient for the classification of Atlen SK as skin sensitiser of category 1 under the CLP regulation and skin sensitiser with assigned phrase R43 and the symbol Xi - 'Irritant' - under the DSD.
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.
