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Diss Factsheets
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EC number: 614-682-8 | CAS number: 68647-95-0
- 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
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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)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- adopted July 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- adopted March 2003
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: main test: 8 weeks; pretest: 9-12 weeks
- Weight at study initiation: 19.6 - 20.5g
- Housing: single in Makrolon type II cages
- Diet (e.g. ad libitum): Stanrab (P) SQC, SDS Special Diets Services, ad lib.
- Water (e.g. ad libitum): tab water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h - Vehicle:
- propylene glycol
- Concentration:
- 1%, 2%, 5%
- No. of animals per dose:
- 2 (pre study)
5 (main study) - Details on study design:
- RANGE FINDING TESTS: 3 pre-tests were performed in 6 animals per test (2/concentration) to determine the highest non irritant concentration. Mice were treated with 100%, 50%, 25%, 10%, 5%, and 2.5% (w/w) on three consecutive days.
- Irritation: at 10% and above, mice showed local irritation confirmed by increased ear weights >25%. In addition, concentrations above 25% also led to ear swelling > 25%. Body weight loss >5% was observed at 50% and 100%. Groups treated with 2.5% and 5% showed no relevant increase in ear weights or eir swelling nor weight loss. Thus 5% was used as the top concentration.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- 25µL of test substance were spread over the entire dorsal surface of each ear for three consecutive days
- 4 days after the first administration, 5mg BrdU were i.p. injected per mouse.
- mice were sacrificed after 24h and BrdU incorporation measured using a commercial cell proliferation assay kit (Roche, Mannheim)
- Criteria used to consider a positive response:
At least one concentration of the test item resulted in an incorporation of BrdU at least 1.6-fold or greater than that recorded in control mice, as indicated by the Stimulation Index.
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.
An increase in ear weight exceeding the threshold value of 25% was considered to be indicative for excessive local skin irritation.
For BALB/c mice, a cutoff-value for the lymph node cell count index of 1.55 was reported for a positive response.
TREATMENT PREPARATION AND ADMINISTRATION: For better handling, the test item was heated at 60°C for 1h (preparations were heated for 20min). Preparations were produced daily on a weight per weight basis and administered lukewarm. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC1.6 value was calculated according to the equation
EC1.6 = (a-c) [(1.6-d)/(b-d)] + c
where EC1.6 is the estimated concentration of the test item required to produce a 1.6-fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 1.6 on the local lymph node assay dose response plot.
For the statistical evaluation of BrdU values, ear weights, lymph node weights and lymph node cell counts, the Mann-Whitney-U test for non-parametric
comparison was applied - Positive control results:
- SI = 4.5
- Parameter:
- SI
- Remarks on result:
- other: 1%: SI = 1 2%: SI = 1.3 5%: SI = 1.8 EC1.6 = 3.8%
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
Reference
A significant increase in lymph node weights and cell counts were observed in the 5% group. Also, ear weights were significantly increased by 15% in this group, but remained below the threshold of excessive irritation (increase > 25%).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Three groups of five female mice each were treated once daily with the test item at concentrations of 1, 2, and 5% (w/w) in propylene glycol by topical application to the dorsum of each ear for three consecutive days. Concentrations at and above 10% led to excessive irritation as determined by ear weight increase > 25% in the pretests performed. Four days after the first topical application the mice were intraperitoneally injected with BrdU. Approximately 24 hours after intraperitoneally injection, the mice were sacrificed and the draining auricular lymph nodes excised, pooled per animal and immediately weighed. Furthermore, after excision of the lymph nodes, both ears of the mice were punched at the apical area using a biopsy punch and were immediately weighed pooled per animal using an analytical balance. Afterwards, single cell suspensions of lymph node cells were prepared from lymph nodes pooled per animal. An aliquot of each cell suspension was used for determination of lymph node cell count. The proliferative capacity of pooled lymph node cells was determined by the incorporation of BrdU. The animals did not show any relevant signs of systemic toxicity or excessive signs of local irritation. Stimulation Indices (S.I.) of 1.0, 1.3 and 1.8 were determined with the test item at concentrations of 1, 2 and 5% (w/w) in propylene glycol, respectively. Based on the S.I.s obtained with 2 and 5% test item concentration, an EC1.6 value of 3.8% (w/w) was calculated. A clear dose response was observed. A statistically significant and biologically relevant increase in BrdU labeling and lymph node weights was observed for the high (5%) dose group. A statistically significant but not biologically relevant increase was also observed for this dose group in lymph node cell count and ear weights.
Migrated from Short description of key information:
LLNA: EC 1.6 = 3.8% (BASF 2012, OECD442B, GLP)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the LLNA fatty acids, C18 -unsatd., dimers, compds. with coco alkylamines was demonstrated to be a skin sensitizer due to a dose dependent increase in lymphocyte proliferation and an S.I. value >1.6 at the highest concentration tested. The EC1.6 value was calculated to be 3.8%. Based on these results Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines is required to be classified with R43 according to 67/548/EEC and as a skin sensitizer cat.1B according to CLP/EU-GHS requirements.
There are no data available for classification as a sensitizer of the respiratory tract.
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.
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