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EC number: 473-130-2 | 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 August 30, 2006 to September 23, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 406, EU Method B.6 and EPA OPPTS 870.2600 Method, in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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
- 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:
- - Name of test material (as cited in study report): Reaktiv Rot F99-0078
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lab-All Bt. Budapest, 1174 Hunyadi u. 7.
- Date of receipt: August 16, 2006
- Body weight range at the beginning of the study: 360-399 g
- Sex: Male.
- Housing: Animals were housed in macrolon cages, size III., with 3 or 2 animals/cage (42 x 42 x 19 cm)
- Bedding: Laboratory bedding, SSNIFF Lignocel 3-4 Fasern
- Diet: Purina Base – Lap gr. diet for rabbit produced by Agribrands Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: Tap water, ad libitum containing 50 mg/100 mL Ascorbic acid.
- Animal health: Only animals in acceptable health condition were used for the test. It was certified by the veterinarian.
- Acclimation period: 14 d
- Animal identification: The animals were marked individually with ear punching. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal numbers.
- Randomisation: All animals were sorted according to weight on the day before the start of the treatment period. After this the animals were allocated to the test groups. The result of the randomisation was checked according to the actual body weights assuring an acceptable homogeneity and variability among the groups.
- Body Weight: The body weights of individual animals were recorded at the beginning and at the end of the experiment. The mean values and the standard deviations were calculated in the test group as well as in the control.
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: August 30, 2006 to September 23, 2006
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiological saline solution (i.e., NaCl 0.9 %) and Freund's complete adjuvant (i.e., FCA) were used for the intradermal applications and physiological saline solution for the dermal applications
- Concentration / amount:
- Induction:
Concentration for intradermal injection: 5%
Concentration for dermal application: 20%
Challenge:
Concentration for dermal application: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiological saline solution (i.e., NaCl 0.9 %) and Freund's complete adjuvant (i.e., FCA) were used for the intradermal applications and physiological saline solution for the dermal applications
- Concentration / amount:
- Induction:
Concentration for intradermal injection: 5%
Concentration for dermal application: 20%
Challenge:
Concentration for dermal application: 25%
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5 - Details on study design:
- Main Study
Induction involved two main procedures: intra-dermal treatments (i.e., Main Study I) and dermal exposure (i.e., Main Study II) with closed patch technique. The intra-dermal and the dermal induction treatments were observed and recorded.
Main Study I: Intra-dermal Induction Exposure
Before starting the exposure an area of approximately 5 x 5 cm on the scapular region of animals was clipped free of hair and shaven close with care.
Intra-dermal treatment
Test groups: A row of three injections, six in all, was made on each side of test animals, as follows:
2 injections with 0.1 mL of Freund's complete adjuvant (i.e., FCA) mixed with physiological saline solution (1:1),
2 injections with 0.1 mL of the test substance (i.e., 5%) homogenized in physiological saline solution,
2 injections with 0.1 mL of test substance (i.e., 5%) mixed with physiological saline solution and homogenized in Freund's complete adjuvant (1:1).
Control group: The control animals were treated similarly as the test group however, the vehicle, without the test substance was used for injections, as follows:
2 injections with 0.1 mL mix of Freund's complete adjuvant and physiological saline solution (1:1)(v/v),
2 injections with 0.1 mL of physiological saline solution,
2 injections with 0.1 mL of 50% w/v physiological saline solution, in a 1:1 mixture (v/v) of Freund's complete adjuvant and physiological saline solution.
Main study II: Dermal Induction Exposure
6 d after the intra-dermal injections, in all animals the test area was painted with 0.5 mL of 10% sodium dodecyl sulphate in Vaseline 24 h prior to topical induction application, in order to create a local irritation.
Approximately 24 h after the painting, the test animals were exposed to test substance on the other hand the control animals were treated with physiological saline solution, as vehicle.
Closed patch was applied in the following manner: in case of the test animals 0.5 mL of test substance (i.e., at concentration of 20%) was spread on the surface prepared previously and covered with a standard (i.e., 5x5 cm) size of porous gauze patch.
Control animals were treated dermally with 0.50 mL of physiological saline solution, as vehicle and the dressing was prepared and applied as for the test animals.
The exposed areas were covered for 48 h with porous gauze fastened with "Leucoplast" (i.e., closed Patch Test).
Main study III: Challenge Exposure
Two weeks after the dermal treatment the animals were exposed to the challenge dose, dermally. 24 h before the challenge treatment the left and the right flank areas (i.e., 5x5 cm) of each animal were prepared for application. The challenge was performed as a dermal exposure (i.e., closed Patch Test).
Left shaved flank areas of the animals (i.e., both the test and the control) were treated with 0.5 mL of the test substance at concentration of 25%. The test substance coloured to the treated skin surface, for this reason the right sides of animals (i.e., both the test and the control) were treated with a safeguard doses at concentrations of 12.5%. Implementation was done as described above in ‘Main study II: Dermal Induction Exposure’. Time of exposure was 24 h.
OBSERVATION AND SCORING The dermal irritation scores (i.e., in case of the preliminary study (primary irritation) and in cases of induction dermal exposures) were evaluated according to the scoring system by Draize (1977). - Positive control substance(s):
- yes
- Remarks:
- (2-mercaptobenzothiazole tested in another study)
Results and discussion
- Positive control results:
- After the challenge treatment positive response was observed in 60% of the treated animals
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% and 12.5% (i.e., safeguard dose) dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% and 12.5% (i.e., safeguard dose) dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control
- Dose level:
- 25% and 12.5% (i.e., safeguard dose) dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control
- Dose level:
- 25% and 12.5% (i.e., safeguard dose) dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
MAIN STUDY
Test group
After the challenge with test substance at concentration of 25% and 12.5% (i.e., as safeguard dose), positive response was not observed on the animals of the test group. The mean of the scores was 0.00 according to the 24 and 48 h results.
Control group
Five control animals were exposed to vehicle during induction treatments and they were treated with the test substance on the challenge day only. No visible changes were found at the 24 and 48 h examinations. During the challenge exposure, the test substance at concentration of 25% and 12.5% (i.e., as safeguard dose) did not evoke primary irritation.
BODY WEIGHT
The individual body weights of the guinea pigs were measured at the beginning and at the end of experiment. There were no notable differences between the test animal group and the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the test substance showed no evidence of sensitizing properties.
- Executive summary:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, EPA OPPTS 870.2600 and EU Method B.6, in compliance with GLP.
Based on the results of a preliminary study, 5 and 20% of test substance in physiological saline solution were selected as intradermal and dermal induction doses. The concentration used for challenge application was 25% test substance in physiological saline solution. Further, as test substance coloured the treated skin surface, the other side of animal (both the test and the control) was treated with a safeguard dose at a concentration of 12.5% in physiological saline solution during challenge exposure.
None of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.
Under the study conditions, the test substance showed no evidence of sensitizing properties.
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.
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