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EC number: 423-970-0 | CAS number: 182926-43-8
- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from Nov. 27, 1996 to Feb. 12, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guidance test with GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report Date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to
- Guideline:
- other: Directive 92/69 EEC, B.6. "Acute Toxicity-Skin Sensitization", July 31, 1992.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown powder
Storage: room temperature
Expiration date: 11/2004
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
Age at delivery: 5 - 7 weeks
Body Weight at delivery: Pretest 384-400 g
Body Weight at beginning of Acclimatization period: Control and Test Group 323 - 415 g
Acclimatization: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visible signs of illness were used for the study.
Conditions
Standard Laboratory Conditions,
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ± 3 °C and for relative humidity between 40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- Intradermal injections: three pairs of intradermal injections (0.1 ml/site)
Epidermal applications: 50 % in bi-distilled water
CHALLENGE: 25 % of test article
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Concentration / amount:
- Intradermal injections: three pairs of intradermal injections (0.1 ml/site)
Epidermal applications: 50 % in bi-distilled water
CHALLENGE: 25 % of test article
- No. of animals per dose:
- control: 5 males
test group: 10 males - Details on study design:
- INDUCTION
Intradermal injections / performed on test day 1: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region.
Epidermal applications / performed on test day 8: One week after the injections, the scapular area was clipped and shaved free of hair. A 2 x 4 cm patch of filter paper was saturated with the test article (50 % in bi-distilled water) and placed over the injection sites of the test animals. The volume of test article applied was approximately 0.3 g. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for 46 hours. The epidermal application procedure described ensured intensive contact of the test article. The guinea pigs of the control group were treated as described above with bi- distilled water only.
CHALLENGE / performed on test day 22: The test and control guinea pigs were challenged two weeks after the epidermal Induction application. The test and control guinea pigs were treated in the same way. Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea pig just prior to the application. Two patches (2x2 cm) of filter paper were saturated with the highest non-irritating concentration of 25 % (left flank) and the vehicle only (bi-distilled water applied to the right flank) using the same method as for the epidermal application. The volume of test article applied was approximately 0.2 ml. The dressings were left in place for 24 hours.
Approximately 21 hours after removal of the dressing the test sites treated with the test article were depilated with an approved depilatory cream. The cream was placed on the patch sites for 3-5 minutes and then washed off with a stream of warm running water. When the application sites were clean and any stains from the test article removed the animals were dried with a disposable paper towel and returned to their cages. - Challenge controls:
- vehicle: bi-distilled water
- Positive control substance(s):
- yes
- Remarks:
- 2-MERCAPTO- BENZOTHIAZOLE and ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
- Positive control results:
- The positive control with 2-MERCAPTO- BENZOTHIAZOLE applied at concentration of 50 % in mineral oil is considered to be a sensitizer when used under the test conditions.
The positive control with ALPHA-HEXYLCINNAMALDEHYDE applied at concentration of 15 % in PEG 400 is considered to be a sensitizer when used under the test conditions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Bi-distilled water only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- Bi-distilled water only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Bi-distilled water only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test group
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test group
- Dose level:
- Bi-distilled water only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Any other information on results incl. tables
SKIN EFFECTS AFTER INTRADERMAL INDUCTION - performed on test day 1
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections.
SKIN EFFECTS AFTER EPIDERMAL INDUCTION - perfumed on test day 8
CONTROL GROUP:
No erythematous or oedematous reaction was observed in the animals treated with bi-disti11ed water only.TEST GROUP:
As the test article stained the skin brownish/red, it was not possible to determine whether erythema was present or not. However no oedema was observed.
SKIN EFFECTS AFTER THE CHALLENGE - performed on test day22
CONTROL AND TEST GROUP
No positive reactions were observed in the animals neither when treated with bi- distilled water alone nor when treated with the test article at25 % in bi-distilled water.
A brownish/red discoloration was noted directly after removal of the patch. To remove discoloration all animals were depilated approximately 3 hours prior to challenge reading.
VIABILITYfMORTALITY / MACROSCOPIC FINDINGS
As there were no deaths during the course of the treatment period no necropsies were performed.
CLINICAL SIGNS, SYSTEMIC: No symptoms of systemic toxicity were observed in the animals.
BODY WEIGHTS
One animal (no. 588) of the test group lost weight during its acclimatization period. It recovered during the treatment period. One animal (no. 600) of the epidermal pretest lost weight during Its test article treatment period.
The body weight of the other animals was within the range of physiological variability known for this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Therefore, the test article FAT45'176/A applied at a concentration of 25 % in bi-distilled water is considered to be a non-sensit1zer when used under the described test conditions.
- Executive summary:
The Maximization-Test was performed with FAT45'176/A in accordance with OECD Guideline No. 406. In this study 0 % of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test article concentration of 25 % in bi-disti1led water. No skin reactions were observed in the control group.
Therefore, the test article FAT45'176/A applied at a concentration of 25 % in bi-distilled water is considered to be a non-sensit1zer when used under the described test conditions.
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