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EC number: 939-273-4 | 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
- Study period:
- from 31 May, 2012 to 11 June, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with EU guideline.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- The diet 4 RF 21 was used instead of 4 RF 18. No effect on results
- Deviations:
- yes
- Remarks:
- The diet 4 RF 21 was used instead of 4 RF 18. No effect on results
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia
Strain: CBA/JN
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 16 to 25 g
- Housing: 1/cage during the study; up to 5 during acclimatisation. Polysulphone solid bottomed cages measuring 35.5 x 23.5 x 19 cm and nesting material
- Diet: 4 RF 21 (Mucedola) Ad libitum throughout the study
- Water: Drinking water supplied to each cage via a water bottle Ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 2°C
- Humidity: 55% ± 15%
- Air changes: Approximately 15 to 20 air changes per hour
- Photoperiod: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary phase : 100, 50, 25, 10, 5% w/w
Main Phase : 10, 5, 2.5% w/w - No. of animals per dose:
- PRELIMINARY PHASE
Group Treatment Dose level Animal number
Number (% w/w)+ Females (odd)
1 Test item 100 1
Test item 50 3
Test item 25 5
Test item 10 7
Test item 5 9
Vehicle 0 11
+ = in terms of test item as supplied
MAIN PHASE
Group Treatment Dose level Animal number
Number (% w/w)+ Females (odd)
1 Vehicle 0 13-19
2 Test item 2.5 21-27
3 Test item 5 29-35
4 Test item 10 37-43
5 Positive control 25 45-51
+ = in terms of test item and positive control item as supplied - Details on study design:
- RANGE FINDING TESTS:
- Irritation: A preliminary irritation test was carried out to select three concentrations to be used in a main assay, according to the criteria described in the relevant guideline for this test. A main phase was then carried out to fully evaluate lymph node cell reaction.
MAIN STUDY
Dosing
Frequency of treatment: Three consecutive days (Days 1, 2, 3) with the test item formulations.
Dose calculation: Dose volume of 25 µL/ear/day (50 µL/animal/day) for each animal.
Dosing method: Topical application of the formulations to the dorsal surface of each ear, using a Gilson micropipette.
Dosing with 5-Bromo-2-deoxyuridine (BrdU)
- Frequency of treatment: Once only, on Day 5.
- Dose calculation: A solution of BrdU, at a concentration of 10 mg/mL in physiological saline (0.9% NaCl) was administered at the dose volume of 0.5 mL/animal.
- Dosing method: Intraperitoneal injection, using 25 G needle and a plastic graded syringe of a suitable volume.
In life observations
- Mortality and morbidity: Twice daily
- Clinical signs: Before dosing on Day 1, and daily after dosing commenced (approximately 1 hour after daily dosing, when applicable)
- Body weight : At allocation (Day 1) and on sacrifice (Day 6)
- Scoring of dermal reaction: The treated sites of all animals were examined daily (once before first dosing, before dosing on Days 2 and 3 and daily thereafter).
- Ear thickness measurement: On Day 1 (before dosing), on Day 3 (before dosing) and on Day 6, ear thickness was measured by a suitable micrometer.
Terminal studies
- Termination : Day 6, approximately 24 hours after BrdU injection.
- Euthanasia method: Carbon dioxide narcosis.
- Necropsy procedure: No necropsy was performed - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Differences between each treated group and the control group (individual BrdU labelling indices) were assessed by Dunnett's test. The homogeneity of the data was verified by Bartlett's test before Dunnett's test. If data were found to be inhomogeneous a Modified t test (Cochran and Cox) was applied.
- Positive control results:
- In the group treated with the positive control item, a stimulation index (SI) of 5.73 was calculated. As it was greater than 2, the test system was regarded as valid.
- Key result
- Parameter:
- SI
- Value:
- ca. 2.48
- Test group / Remarks:
- Group n. 2 at a dose level of 2.5%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.85
- Test group / Remarks:
- Group n. 3 at a dose level of 5%
- Key result
- Parameter:
- SI
- Value:
- ca. 4.04
- Test group / Remarks:
- Group n. 4 at a dose level of 10% w/w selected as highest dose on the basis of the preliminary study.
- Cellular proliferation data / Observations:
- Statistically significant and dose-related increases in cell proliferation of draining lymph nodes were observed in the three treatment groups, being the calculated stimulation indices (SI) 2.48, 2.85 and 4.04, respectively at low, mid- and high dose levels. A single animal of the negative control group (animal no. 91150019) showed an abnormally sized lymph node which caused a high response when compared to the group-mates and to the normal ranges observed in this experimental conditions. Therefore, although no reason for this abnormal result was found, these outlier data were excluded.
- Interpretation of results:
- other: Category 1B (indication of skins sensitising potential) based on CLP criteria
- Conclusions:
- The results obtained in this study indicate that the test item may elicit a sensitisation response in mice following dermal exposure.
- Executive summary:
The potential of the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, to cause skin sensitisation reactions following topical application to the skin of CBA/JN (CBA/J) mice, was assessed using the LLNA:BrdU-ELISA method, according to the OECD Guideline for testing of chemicals no. 429.
Preliminary phase
Five concentrations (100, 50, 25, 10, 5% w/w) in acetone:olive oil 4:1 (v/v) were selected to be used in the preliminary phase, in order to identify a non toxic and minimally irritant concentration and avoid false positive results. No signs of toxicity (toxicologically relevant clinical signs or body weight losses) were observed at the tested concentrations. According to the results of the irritation screening, the concentration judged as minimally irritant was 10% w/w.
Main assay
In the main assay, the test item was topically administrered at the concentrations of 10, 5 and 2.5% w/w, in acetone:olive oil 4:1 (v/v).
No mortality or clinical signs were recorded in any animal. Changes in body weight observed during the study were within the expected range for this strain and age of animals. Statistically significant and dose-related increases in cell proliferation of draining lymph nodes were observed in the three treatment groups, being the calculated stimulation indices (SI) 2.48, 2.85 and 4.04, respectively at low, mid- and high dose levels. The results obtained in this study indicate that the test item may elicit a sensitisation response in mice following dermal exposure. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
Classification: Category 1B
Signal word : Warning
Hazard statement: H317: May cause an allergic skin reaction
Reference
Preliminary test
Five concentrations (100, 50, 25, 10, 5% w/w) were selected to be used in the preliminary phase.
No toxicity signs (clinical signs or toxicologically relevant body weight losses) were observed at any of the tested concentrations.
The evaluation of visible reactions was as follows:
-Very slight to well defined erythema (scores of 1 and 2) was observed at the concentrations of 100 and 50% w/w;
-Very slight erythema (score of 1) was recorded at the concentration of 25% w/w;
-Desquamation and/or hardening of the treated ears were observed at the concentrations of 100, 50 and 25% w/w;
-No erythema was recorded at the concentrations of 10 and 5% w/w.
The evaluation of ear thickness indicated that the reaction was acceptable (increase of less than 25% compared to Day 1) at the concentrations of 10 and 5% w/w.
The evaluation of ear punch weight indicated that the reaction was acceptable (increased less than 25% with respect to the negative control) at the concentrations of 25, 10 and 5% w/w.
Main assay
Body weight decreases/reduced body weight gains observed in some animals from all treated groups were considered of low entity and/or incidental and, thus, not toxicologically relevant.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A possibility that the LLNA study is giving a false positive result exists, supported by the fact that with irritant substances this is not a very reliable test, even if Regulation recommend it always as a first choice.
The study has been performed on a dose-range where the irritating effect seems not being interferring with the test result, but the doubt remains.
We didn't performe an in vivo study for confirmation and assumed the classification as a conservative approach, taking also into account that the raw material too has been classified as sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test item is considered to induce sensitisation when the SI for any single treatment dose group is ³ 1.6. Following the reported table:
Group |
% |
SI |
1 |
0 |
1 |
2 |
2.5 |
2.48 |
3 |
5 |
2.85 |
4 |
10 |
4.04 |
5 |
25 |
5.73 |
and according to Reg. 286/2001 (II ATP CLP) a substance has to be classified as a sensitizer category 1B if the EC3 value > 2%. In this case the EC3 value (where SI = 3) is between concentrations of 5 -10%.
Therefore the proposed classification is H317, category 1B
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