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EC number: 939-412-9 | CAS number: 85586-38-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2018 - January 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Substanceclass is know to lead to false positive results in LLNA Test, therefore a Guineapig is conducted.
Test material
- Reference substance name:
- Sulfuric acid, mono-C8-18-alkyl esters, magnesium salts, compds. with triethanolamine
- EC Number:
- 287-840-3
- EC Name:
- Sulfuric acid, mono-C8-18-alkyl esters, magnesium salts, compds. with triethanolamine
- Cas Number:
- 85586-38-5
- IUPAC Name:
- 85586-38-5
- Test material form:
- solid
- Remarks:
- dried from of a reaction mixture, water and cyclohexanol where evaporated
- Details on test material:
- Homogeneity: The test item was homogeneous by visual inspection.
Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Expiry date: February 2020
Storage conditions: Room temperature
pH-value: Approx. 7 (moistened with water, determined by Bioassay Laboratories)
Constituent 1
- Specific details on test material used for the study:
- For anayltical details see study report No. 18L00152
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Dunkin Hartley, Crl:HA, SPF
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: spf
- Age at study initiation: no specified
- Weight at study initiation: 250 g – 274 g
- Housing:
Type of cage:
Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
Enrichment:
Wooden gnawing blocks (Type KNH E-041); Abedd ® Lab. and Vet. Service GmbH Vienna, Austria
Bedding:
H 15005-29; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
Number of animals per cage:
5
- Diet (e.g. ad libitum): FD1 SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period:Acclimatization period of at least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +- 3°C;
- Humidity (%):30 - 70%
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light):12h/12h
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- Polyethylene glycol 400
- Concentration / amount:
- 1st induction (60 %): suspension (paste)
2nd and 3rd induction (50%): suspension (paste) - Day(s)/duration:
- Exposure period: 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- Concentration test item 50 % (w/w)
- Day(s)/duration:
- Duration of exposure: 6 hours
Readings: 24, 48 and 72 h after the removal of the patch - Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
In accordance with the cited guidelines a mild irritating concentration should be used in the main test for induction, whereas the maximum non-irritant concentration should be applied for challenge.
Amount applied: 0.5 g or 0.5 mL of the test item preparation was applied to each animal.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test item preparations were applied to the skin of the flanks under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (4 x 4 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 6 hours
Application site: Right and left flank anterior and posterior
Application frequency: One application
Number of test animals: 3
Readings: 1, 24, 48 and 72 h after removal of the patch
The animals were distributed as follows:
Flank region
(application site) Concentration % Number of Animals per Group
Left anterior 60 3
Left posterior 50 3
Right anterior 25 3
Right posterior 10 3
In the pretest, the highest concentration that could be technically used was 60% (w/w).
MAIN STUDY
Number of animals of the control group:10
Number of animals of the test group:20
A. INDUCTION EXPOSURE
3 inductions were conducted (day 0, 7 and 14)
Amount applied: 0.5 g of the test item preparation were applied to each test group animal. The control group received 0.5 mL of the vehicle.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test item preparation or vehicle were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (4 x 4 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 6 hours
Application site: Intact flank
Test item preparation (test group): left flank anterior
Vehicle (control group): left flank anterior
Due to distinct skin irritation in the test group the patches were shifted to the middle part of the left flank during the third induction.
Concentration of test item: 1st induction: 60 % (w/w)
2nd and 3rd induction: 50 % (w/w)
Application frequency: Three times at weekly intervals; days 0, 7 and 14 on the same or shifted application area
Readings: 24 h after the removal of the patch
The control group was treated analogously to the test group but only with the vehicle without the test item.
B. CHALLENGE EXPOSURE
The challenge was carried out 13 days after the third induction.
Amount applied: 0.5 g of the test item preparation and 0.5 mL of the vehicle were applied to each animal.
Occlusive dressing: 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing the test item preparation or vehicle were applied to the skin of the flank under an occlusive dressing. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (4 x 4 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG.
Duration of exposure: 6 hours
Application site: Intact flank
Test item preparation: right flank posterior
Vehicle: left flank posterior
Concentration test item: 50 % (w/w)
Readings: 24, 48 and 72 h after the removal of the patch
The control group was treated analogously to the test group.
Positive control
A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen. - Positive control substance(s):
- yes
- Remarks:
- A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Total
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- other: In total, 4/20 test group animals showed skin reactions after 24 and 48 hours after removal of the patches.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Executive summary:
"Confidential item" was tested for its sensitizing effect on the skin of the guinea pig in the BUEHLER Test based on the method of BUEHLER, E.V. (1965) and according to OECD Guideline 406 (1992), the council regulation (EC) No 440/2008 part B.6. (2008) and the U.S. EPA OPPTS 870.2600 (2003) and MAFF 8147, 2000 guideline.
The test item concentrations for the main test were selected based on the results of the pretest, in which 3 guinea pigs of the same animal strain in total were used. In the pretest, the highest concentration that could be technically used was 60% (w/w). Therefore, descending concentrations of 60, 50, 25 and 10% (w/w) in polyethylene glycol 400 were chosen.
Based on the data of the pretest, the first induction was performed with a 60% (w/w) test item preparation in polyethylene glycol 400. Due to distinct local skin findings after the first induction, the second and third induction was performed with a 50% (w/w) test item preparation in polyethylene glycol 400. Likewise, a 50% test item preparation in polyethylene glycol 400 was chosen for the challenge application.
The main study was performed using 1 control group, which consisted of 10 animals and 1 test group, which consisted of 20 animals.
The inductions were performed on days 0, 7 and 14.
A challenge was carried out 13 days after the last induction.
In the main study, the animals did not show any signs of systemic toxicity.
As expected, no local skin findings could be observed in the control group neither after the inductions nor the challenge.
In the test group, 13 animals (13/20) revealed discrete or moderate erythema (grade 1 or 2) after the first induction, while after the second induction these skin findings were observed in 18 animals (18/20) animals. 13 animals (13/20) showed discrete or moderate erythema after the third induction.
After the challenge 4 animals (4/20) in total showed the following skin findings:
Discrete erythema (grade 1)Due to the unambiguous findings of the challenge, a second challenge was not performed.
Based on the results of this study and applying the evaluation criteria cited in chapter 3.8, it was concluded that "confidential testitem" has a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.
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