Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 274-402-1 | CAS number: 70210-05-8
- 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
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Source: Recognised as the recommended test system Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst / The NetherlandsNumber of animals for the pre-test (non-GLP): 2 females Number of animals for the main study: 16 females (experiment 1), 8 females (experiment 2) Number of animals per group: 4 females (nulliparous and non-pregnant)Number of test groups: 3 (experiment 1) 1 (experiment 2)Number of control (vehicle) group: 1 (experiment 1 and 2, each) Age: 7 - 8 weeks (beginning of acclimatization) Identification: Single caging. The animals will be distributed into the test groups at random and identified by cage number. Acclimatisation : Under test conditions after health examination. Only animals without any visible signs of illness will be used for the study.The animals were kept conventionally. The experiment was conducted under standard laboratory conditions. Housing: single Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen) Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen) Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen) Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf) Environment: temperature 22 + 3°C; relative humidity 24-70%; artificial light 6.00 a.m. - 6.00 p.m.
- Vehicle:
- propylene glycol
- Concentration:
- 4, 8, and 16.0 % (w/v).
- No. of animals per dose:
- 4 animals per dose
- Details on study design:
- The main experiment was repeated with the high dose of 16% (experiment 2), since in the first experiment on the first day of application accidentally 12% was used for the high dose. Topical Application 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 4,.8 and 16% (w/v) in propylene glycol. The application volume, 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). Administration of 3H-Methyl Thymidine 3H-methyl thymidine (3HTdR) was purchased from Amersham International (Amersham product code no. TRA 310; specific activity, 2 Ci/mmol; concentration, 1 mCi/m1). Five days after the first topical application, all mice were administered with 250 ul of 79.1 (experiment 1) and 80.1 (experiment 2) uCi/m1 3HTdR (corresponds to 19.775 (experiment 1) and 20.025 (experiment 2) uCi 3HTdR per mouse) by intravenous injection via a tail vein. Determination of Incorporated 3HTdR Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Na-thiopental (Trapanal, Altana, D-78467 Konstanz). The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 pm mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to glass scintillation vials with 10 ml of 'Ultima Gold' scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was then measured on a 3-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1m1-aliquots of 5 % trichloroacetic acid. The 13-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- In Experiment 1, Stimulation Indices of 0.7 and 0.8 were determined with the test item at concentrations of 4 and 8 % (w/v) in propylene glycol, while for the group treated with 12/16 % an S.I. of 0.9 was determined. In Experiment 2 an S.I. of 2.1 was obtained with the test item at a concentration of 16 % (w/v). The difference between the values obtained for the high dose in experiments 1 and 2 was considered to reflect the normal variation range of the LLNA. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
- Key result
- Parameter:
- SI
- Value:
- ca. 0.7
- Test group / Remarks:
- TG2
- Key result
- Parameter:
- SI
- Value:
- ca. 0.8
- Test group / Remarks:
- TG3
- Key result
- Parameter:
- SI
- Value:
- ca. 0.9
- Test group / Remarks:
- TG4
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The substance is considered to be a non-sensitizer substance.
- Executive summary:
In this study the test item suspended in propylene glycol was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed on three groups each of four female mice, treated with different concentrations of the test item by topical application at the dorsum of each ear lobe (left and right) on three consecutive days. One control group of four mice were treated with the vehicle only.
The test item concentrations were 4, 8 and 16%. Accidentally, animals of the high dose group were treated with a concentration of 12 % instead of 16 % on the first day (the high dose group in Experiment 1 is therefore designated as “12/16 %”). Consequently, the high dose group (16 %) was repeated in Experiment 2.
Approximately five hours after intravenous injection, the mice were sacrificed and 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 3H-methyl thymidine measured in a ß-scintillation counter.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Due to the intense red colour of the test item local irritation reactions such as ear redness could not be detected.
In Experiment 1, Stimulation Indices of 0.7 and 0.8 were determined with the test item at concentrations of 4 and 8 % (w/v) in propylene glycol, while for the group treated with 12/16 % an S.I. of 0.9 was determined. In Experiment 2 an S.I. of 2.1 was obtained with the test item at a concentration of 16% (w/v). The difference between the values obtained for the high dose in experiments 1 and 2 was considered to reflect the normal variation range of the LLNA.
Therefore the substance is classified as non-sensitizer substance.
Reference
Viability / Mortality
No deaths occurred during the study period.
Clinical Signs
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Due to the intense red colour of the test item local irritation reactions such as ear redness could not be detected.
Body Weights
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One study (Clariant, 2005) has been chosen as key study for the skin sensitization endpoint.
The test follows the OECD Test guideline 429 and in accordance to GLP principles and it was performed on Acid Violet 054.
The Stimulation Indices in the performed tests is < 3, therefore the substance is considered not sensitising
Another study (Huntsman, 1994) is available for Acid Violet 054 and it was used as supporting.
The test follows the OECD Test guideline 406 and in accordance to GLP principles.
No allergenic potential of the test article was observed.
Therefore also the albino guinea pigs test confirm that the tested substance is not sensitising.
Migrated from Short description of key information:
not sensitising
Justification for selection of skin sensitisation endpoint:
This is a new study performed on a pure and analytically well identified substance, in GLP, fully reliable
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
According to CLP Regulation, For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay. Since the SI in the performed tests is < 3, no classification for sensitisation is warranted under Regulation 1272/2008
Justification for classification or non-classification
No classification for sensitisation is warranted under Regulation CE 1272/2008
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.