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EC number: 461-290-6 | CAS number: 167374-38-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in compliance with GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study from 1998; relevant test system then
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): X-E-OXIMETHER
- Analytical purity: 98.4%
- Batch No.: 26249/176
- Substance No.: 96/288
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: Pirbright White, Dunkin Hartley Crl: (HA) BR [SPF]
- Source: Charles River GmbH - Wiga, Kisslegg, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 291 - 342 g
- Housing: 5 animals per cage
- Diet (ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland
- Water (ad libitum): Tap water (about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week)
- Acclimation period: 7 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1% Tylose CB 30.000 (cleaned sodiumcarboxymethylcellulose) in aqua bidest
- Concentration / amount:
- The intradermal and percutaneous inductions were performed with a 5% and a 50% test substance preparation in 1% Tylose (cleaned sodiumcarboxymethylcellulose in aqua bidest.) respectively, whereas for the challenge a 25% test substance preparation in the same vehicle was chosen.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% Tylose CB 30.000 (cleaned sodiumcarboxymethylcellulose) in aqua bidest
- Concentration / amount:
- The intradermal and percutaneous inductions were performed with a 5% and a 50% test substance preparation in 1% Tylose (cleaned sodiumcarboxymethylcellulose in aqua bidest.) respectively, whereas for the challenge a 25% test substance preparation in the same vehicle was chosen.
- No. of animals per dose:
- 10
- Details on study design:
- Pretest:
2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flanks under an occlusive dressing. Test sites were visually evaluated 24 h and 48 h after application of test solutions. In accordance with the OECD Guideline 406 a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.
Main study
- Intradermal induction:
Intradermal induction using adjuvant technique has been recommended to enhance immune response so that weak sensitizing compounds can be detected. 6 intradermal injections were conducted. 4 animals were administered 100 µl of the test substance formulation and the 2 other served as control. Skin readings were performed 24 h after application.
- Percutaneous induction:
Percutaneous induction was carried out one week after intradermal induction. 2 x 4 cm filter paper strips containing the test substance formulation were applied to the skin of the shoulder for 48 h under an occlusive dressing. The filter paper strip was coated with an approx. 0.5 mm thick layer of the test substance formulation. The control groups were treated analogously to the test group but only with the solvent without the test substance. Skin readings were performed 48 h after application.
- Challenge:
Fourteen days after percutaneous induction, 2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flank for 24 h under an occlusive dressing. The filter paper strip was soaked in the test substance formulation. Skin reactions were read at 24 and 48 after the removal of the patch.
Evaluation:
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 30 per cent of the test animals exhibit skin reactions. - Positive control substance(s):
- no
- Remarks:
- A positive control with a known sensitizer was not included in this study. However, a separate study was performed twice a year in the same laboratory.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Clinical observations:
- Slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
- No. with + reactions:
- 4
- Total no. in group:
- 8
- Clinical observations:
- Well-defined erythema, slight edema in 2 of them
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 4.0. Total no. in groups: 8.0. Clinical observations: Well-defined erythema, slight edema in 2 of them.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
- No. with + reactions:
- 1
- Total no. in group:
- 8
- Clinical observations:
- Moderate erythema, slight edema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 1.0. Total no. in groups: 8.0. Clinical observations: Moderate erythema, slight edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
- No. with + reactions:
- 2
- Total no. in group:
- 8
- Clinical observations:
- Slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
- No. with + reactions:
- 3
- Total no. in group:
- 8
- Clinical observations:
- Well-defined erythema, scaling in 1 of them
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 3.0. Total no. in groups: 8.0. Clinical observations: Well-defined erythema, scaling in 1 of them.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.
- No. with + reactions:
- 1
- Total no. in group:
- 8
- Clinical observations:
- Moderate erythema, slight edema, scaling
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% test substance preparations in Tylose CB 30.000, 1% in aqua bidest.. No with. + reactions: 1.0. Total no. in groups: 8.0. Clinical observations: Moderate erythema, slight edema, scaling.
Any other information on results incl. tables
Pretest:
The pretest was performed with 4 female animals for percutaneous and with 2 female animals for intradermal induction.
In the intradermal pretest, injection of a 5% test substance preparation caused well-defined erythema and slight edema in all test group animals. For the percutaneous induction, the 5%, 10 and 25% test substance preparations did not cause any skin reactions. After application of the 50% test substance preparation discrete or patchy erythema were observed in 2 out of 4 animals. Therefore the 5 and 50% test substance preparations were used for intradermal and percutaneous inductions respectively, whereas the 25% test substance preparations were applied for challenge.
Induction:
After the intradermal induction, well-defined erythema and slight edema were observed at the injection sites of all control group animals and all test group animals at which only Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) was applied. Injections of 5% test substance preparations in Tylose CB 30.000, 1% in aqua bidest. or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) caused well-defined erythema and slight edema in all test group animals. The injection sites of all control group animals at which Tylose CB 30.000, 1% in aqua bidest. was applied, did not show any skin reactions.
After the percutaneous induction with a 50% test substance preparation, incrustation, partially open (caused by the intradermal induction), were observed in addition to well-defined erythema and slight edema in all test group animals. The animals of control groups, which were applied with Tylose CB 30.000, 1% in aqua bidest., exhibited the same skin reactions as the animals of the test group.
Challenge:
The challenge with a 25% test substance preparation caused very slight erythema in 2 out of 8 test group animals 24 hours after removal of the patches. Well-defined erythema was observed in 4 test group animals, whereas 2 out of these animals additionally showed very slight edema. 1 test group animal exhibited moderate erythema and slight edema.
48 hours after removal of the patches very slight erythema was noted in 2 out of 8 test group animals. In 3 test group animals well-defined erythema was observed, in 1 out of them with scaling. 1 test group animal showed moderate erythema, slight edema and scaling.
The animals of control group did not show any skin reactions. Tylose CB 30.000, l% in aqua bidest., which was applied as a vehicle control to all animals, did not cause any skin reactions.
The number of animals with skin findings after the challenge:
|
24 h |
48 h |
Control group |
0/8 |
0/8 |
Test group |
7/8 |
6/8 |
x/y: number of positive reactions/number of animals tested (reading at 24 h and/or 48 h after the removal of the patch)
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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