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EC number: 435-190-8 | CAS number: 246871-16-9
- 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 15-DEC-1999 to 15-MAY-2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guidance test with GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 96/54/EEC, B.6. "Acute Toxicity - Skin Sensitization", July 30, 1996.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: FAT41'029/A
Batch number: ARL 123/PP 1/99 UL
Purity: approx. 98 %
Color / Physical form: orange red to brown powder
Stability of test article: Stable under storage conditions
Expiry date: 04-NOV-2005
Storage conditions: In the original container, at room temperature (range of 20 ± 3 °C), away from direct sunlight
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST SYSTEM
Test system: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
Source: RCC Ltd Biotechnology & Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
Number of animals for main study / pretest: 15 female / 3 female animals
Age at delivery: 4-6 weeks
Body weight at beginning of acclimatization period: 359 - 406 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.
HUSBANDRY
Conditions
Standard Laboratory Conditions:
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with a range for room temperature of 22±3 °C, and for relative humidity between 40-70 %. The animals were provided with a 12-hour light, 12-hour dark cycle. Music was played during the light period.
Accommodation: Individually in Makrolon type-4 cages with standard softwood bedding
Diet: Pelleted standard Nafag Ecosan 845 25W4, batch nos. 85/99 and 96/99, guinea pig breeding / maintenance diet, containing Vitamin C, ad libitum.
Water: Community tap-water.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: PEG 300
- Concentration / amount:
- MAIN STUDY
INTRADERMAL INJECTIONS / PERFORMED ON TEST DAY 1
An area of dorsal skin from the scapular region (approximately 6x8 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
On test day 8, a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in PEG 300) and placed over the injection sites of the test animals. The amount of test article preparation 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 occlusive dressings were left in place for 48 hours. The epidermal application procedure described ensures intensive contact of the test article. The guinea pigs of the control group were treated as described above with PEG 300 only, applied at a volume of approximately 0.3 ml.
CHALLENGE / PERFORMED ON TEST DAY 22
The test and control guinea pigs were challenged two weeks after the epidermal induction application and 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 (3x3 cm) of filter paper were saturated with the test article at the highest non-irritating concentration of 25 % (left flank) and the vehicle only (PEG 300 applied to the right flank) using the same method as for the epidermal application. The volume of test article preparation and vehicle applied was approximately 0.2 ml. The dressings were left in place for 24 hours.
Twenty-one hours after removal of the dressing the test sites treated with the test article were depilated as described in the epidermal pretest. The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: PEG 300
- Concentration / amount:
- MAIN STUDY
INTRADERMAL INJECTIONS / PERFORMED ON TEST DAY 1
An area of dorsal skin from the scapular region (approximately 6x8 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
On test day 8, a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in PEG 300) and placed over the injection sites of the test animals. The amount of test article preparation 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 occlusive dressings were left in place for 48 hours. The epidermal application procedure described ensures intensive contact of the test article. The guinea pigs of the control group were treated as described above with PEG 300 only, applied at a volume of approximately 0.3 ml.
CHALLENGE / PERFORMED ON TEST DAY 22
The test and control guinea pigs were challenged two weeks after the epidermal induction application and 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 (3x3 cm) of filter paper were saturated with the test article at the highest non-irritating concentration of 25 % (left flank) and the vehicle only (PEG 300 applied to the right flank) using the same method as for the epidermal application. The volume of test article preparation and vehicle applied was approximately 0.2 ml. The dressings were left in place for 24 hours.
Twenty-one hours after removal of the dressing the test sites treated with the test article were depilated as described in the epidermal pretest. The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema according to the method of Magnusson and Kligman.
- No. of animals per dose:
- 10 animals for test group and 5 animals for control group
- Details on study design:
- OBSERVATIONS
Viability / Mortality: Daily from delivery of the animals to the termination of the test.
Clinical signs (local / systemic): Daily from delivery of the animals to the termination of the test.
Skin reactions: At the times specified during the pretest, induction and challenge periods.
Body weights: At pretest and acclimatization start, day 1 and termination of the test.
PATHOLOGY
NECROPSY
No necropsies were performed in the animals of the control and test group sacrificed at termination of the observation period nor in the animals of the intradermal and epidermal pretest sacrificed on test day 1 of the main study. The animals were sacrificed by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight and discarded. - Challenge controls:
- vehicle: PEG 300
- Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
- Positive control results:
- ALPHA-HEXYLCINNAMALDEHYDE applied at a concentration of 1 % in PEG 300 has to be classified and labelled as a skin sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 % in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- PEG 300 only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- PEG 300 only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % in PEG 300
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % in PEG 300. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- PEG 300 only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % in PEG 300
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in PEG 300. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- PEG 300 only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed in the animals.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: PEG 300 only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of systemic toxicity were observed in the animals..
Any other information on results incl. tables
SKIN EFFECTS AFTER INTRADERMAL INDUCTION - PERFORMED ON TEST DAY 1
The expected and common findings were observed in the control and test group after the different applications using FCA intradermally and consisted of erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation. No description of the results is given in the report as these FCA effects are well-known.
SKIN EFFECTS AFTER EPIDERMAL INDUCTION-PERFORMED ON TEST DAY 8
CONTROL GROUP: No erythematous or oedematous reaction was observed in the animals treated with PEG 300 only.
TEST GROUP: As the test article at 50 % stained the skin red, it was not possible to determine whether erythema was present or not. However, no oedema was observed.
SKIN EFFECTS AFTER THE CHALLENGE - PERFORMEDON TEST DAY 22
CONTROL GROUP: No skin reactions were observed in the animals when treated with either PEG 300 only or when treated with the test article at 25 % in PEG 300. Red discoloration produced by the test article was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
TEST GROUP: Discrete/patchy to moderate/confluent erythema were observed in six (at the 24-hour reading) and discrete/patchy erythema in five (at the 48-hour reading) out of 10 animals after treatment with the test article at 25 % in PEG 300. No skin reactions were observed in the animals treated with PEG 300 only. Red discoloration produced by the test article was noted directly after removal of the patch. To remove the discoloration all animals were depilated 3 hours prior to challenge reading.
VIABILITY / MORTALITY / MACROSCOPIC FINDINGS
There were no deaths during the course of the study, hence no necropsies were performed.
CLINICAL SIGNS, SYSTEMIC
No signs of systemic toxicity were observed in the animals.
BODY WEIGHTS
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Test article is considered to possess skin sensitizing potential in albino guinea pigs.
- Executive summary:
In order to assess the cutaneous allergenic potential of FAT41'029/A, the Maximization-Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6.
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 10 % dilution of the test article in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test article at 50 % in PEG 300 one week after the intradermal induction and following pretreatment of the test areas with 10 % Sodium-Lauryl-Sulfate (SLS) 23 hours prior to application of the test article. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion following pretreatment with 10 % SLS. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test article at 25 % in PEG 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. Six out of 10 test animals showed discrete/patchy to moderate/confluent erythema at the 24-hour reading and five out of 10 test animals showed discrete/patchy erythema at the 48-hour reading after the challenge treatment with FAT41'029/A at 25 % (w/w) in PEG 300. No skin effect was observed in the control group.
Based on the above mentioned findings in an adjuvant sensitization test in guinea pigs, FAT41'029/A is classified as a skin sensitizer.
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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