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EC number: 443-940-0 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jun. 04, 2002 to Sep. 19, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to EU Method B.5. OECD Guideline 405 and OPPTS 870.2400 in compliance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: M&B A/S P.O.box 1079 DK-8680 Ry, Denmark
- Weight at study initiation: 377±22 g
- Housing: Transparent macrolon cages (type 5) on soft wood granulate in groups of 5 animals
- Diet: ssniff R/M-H, ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
IN-LIFE DATES: From: Jun. 04, 2002 To: Jul. 05, 2002
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Determination of the primary non-irritant concentration: 1, 5 and 25 %
- Determination of the tolerance of the intradermal injections: 0.2, 1 and 5 %
- Challenge treatment· control and treatment group: 25 %
Challengeopen allclose all
- Route:
- other: dermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Determination of the primary non-irritant concentration: 1, 5 and 25 %
- Determination of the tolerance of the intradermal injections: 0.2, 1 and 5 %
- Challenge treatment· control and treatment group: 25 %
- No. of animals per dose:
- - Determination of the primary non-irritant concentration: 3
- Determination of the tolerance of the intradermal injections: 2
- Control group: 5
- Treatment group: 10
- Details on study design:
- RANGE FINDING TESTS:
Determination of the primary non-irritant concentration:
The following test concentrations were administered to the flanks of 3 guinea pigs:
1. 25.0 % in sesame oil (left flank); 5.0 % in sesame oil (right flank)
2. 25.0 % in sesame oil (left flank); 1.0 % in sesame oil (right flank)
3. 05.0 % in sesame oil (left flank); 1.0 % in sesame oil (right flank)
0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 h with a bandage and film. 24 h after removal of the patches, the treated skin areas were examined for erythema and edema.
Determination of the tolerance of the intradermal injections:
The following preparations were administered twice by intradermal injection to 2 guinea pigs:
Site 1. 2X0.1 mL 5.0 % in sesame oil
Site 2. 2X0.1 mL 1.0 % in sesame oil
Site 3. 2X0.1 mL 0.2 % in sesame oil
24, 48, 72 and 96 h after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 2
- Exposure period: 1-7 d
- Test groups: Yes
- Control group: Yes, (50 % Freund's Adjuvant)
- Site: Dorsal area
- Frequency of applications: 2 in 7 d
- Duration: 7 d
- Concentrations: 5.0 % test substance in sesame oil
INDUCTION EXPOSURE (Dermal)
- No. of exposures: 0.5 mL of the test substance preparation as cellulose patch
- Test groups: Yes, 25.0 % test substance in sesame oil
- Control group: Yes, sesame oil
- Site: Dorsal area
- Frequency of applications: Single on Day 8
- Concentrations: 25.0 % test substance in sesame oil
B. CHALLENGE EXPOSURE (Dermal)
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Test groups: An amount of 0.5 mL 25.0 % test substance in sesame oil
- Control group:
- Site: Left flank
- Concentrations: 25 % test substance in sesame oil
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
OTHER:
The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have - Challenge controls:
- Not reported
- Positive control substance(s):
- yes
- Remarks:
- (Alpha-hexyl cinnamic aldehyde)
Study design: in vivo (LLNA)
- Vehicle:
- other: Not applicable
- Concentration:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Positive control substance(s):
- other: Not applicable
- Statistics:
- No data
Results and discussion
- Positive control results:
- Alpha-hexyl cinnamic aldehyde was skin sensitiser and proved to be suitable for the determination of dermal sensitizers
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % test substance in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % test substance in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % test substance in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % test substance in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 % Alpha-hexyl cinnamic aldehyde in polyethylene glycol 400 (Day 22)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- 9 animals (90 %) showed a positive reaction during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 25 % Alpha-hexyl cinnamic aldehyde in polyethylene glycol 400 (Day 22) . No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: 9 animals (90 %) showed a positive reaction during the observation period. .
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Not applicable
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Any other information on results incl. tables
Results:
Determination of the tolerance of the intradermal injections
Intradermal injections with the 5.0, 1.0 and 0.2 % preparation caused slight erythema and edema. Based on this preliminary test, a 5 % preparation was selected for the intradermal injections in the main test.
Determination of the primary non-irritant concentration
No signs of irritation occurred after administration of the different test concentrations. Based on these results, a concentration of 25 % test substance in sesame oil was chosen for the challenge at Day 22.
Main test for the sensitizing properties
Body weight gains and clinical signs:
The body weight gains of the animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.
Intradermal induction treatment
Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in sesame oil showed slight erythema and edema. Intradermal injections of the vehicle alone exhibited no signs of irritation. Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at Day 7.
Dermal induction treatment
After the removal of the patches at Day 10, severe erythema and edema, indurated and encrusted skin were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance showed slight erythema and edema. The administration site treated with the vehicle alone showed no signs of irritation.
Dermal challenge treatment
No skin reactions were observed in the control and the treatment group 24 and 48 h after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in female guinea pigs (Magnusson & Kligman method) according EU Method B.6., OECD guideline 406 and OPPTS 870.2400 in compliance with GLP.
Intradermal induction was performed using 5 % test substance in sesame oil. Dermal induction and challenge treatment were carried out with 25 % test substance in deionised water.
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the Buehler test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
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