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Diss Factsheets
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EC number: 434-050-3 | 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:
- 2002-04-11 to 2002-05-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- yes
- Remarks:
- unclear how long the epidermal induction period lasted;
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2001-08-22
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to the REACH regluation (EC) No. 1907/2006, the LLNA test is the first-choice method for in vivo testing and in exceptional circumstances another test can be used. Since the study was carried out before the regulation entered into force and the guinea pig maximisation test according to OECD 406 is an acceptable method for testing skin sensitisation, it is not justified to conducted an additional LLNA test due to animal welfare.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation:
yellow green powder
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, D-33178 Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: < 1 year
- Weight at study initiation: 255 - 326 g
- Housing: housed individually Macrolon cages (Surface: 780 cm²)
- Diet: Raiffeisen Ringfutter, Trockenfutter 52 P Raiffeisen, Kraftfutter Kehl
- Water (ad libitum): tap water (additive: 20 mg ascorbic acid and 100 mg citric acid per 100 mL water)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- 0.1 mL of Freund's complete adjuvant (diluted 1:1 with aqua ad iniectabilia)
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 0.1 mL of 5 % concentration
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 0.1 mL of 5 % test item in a 1:1 mixture (v/v) Freund's complete adjuvant/aqua ad iniectabilia
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 50 % test item
- Day(s)/duration:
- Day 7
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 50 % test item
- Day(s)/duration:
- Day 21 (exposure duration: 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (test substance) + 5 (controls)
- Details on study design:
- RANGE FINDING TESTS:
Six Dunkin-Hartley guinea pigs were used for the preliminary test: 3 animals for the topical administration and 3 animals for the intracutaneous administration.
a) Intracutaneous administration:
The back of the animals was shaved. Two intradermale injections (100 µL each) of the same test item concentrations were injected on each side of the spinal column. The test material was mixed with sesame oil. Three concentrations were tested during the preliminary test (1, 3, and 5 % of the test item). The injection side were investiged for erythema and oedema 24, 48, and 72 hours after administration.
Results:
No erythema or oedema was observed at any concentration. Therefore, the 5 % concentration was used in the main study even no skin irritation was observed.
b) Topical administration:
Three test item concentrations were used for the topical administration (20, 33, and 50 % (m/v) of the test item). The test material was mixed with sesame oil. The back of the animals was shaved and the test substances was applied onto a patch that was placed on the back. The patch was fixed with occlusive dressing for a duration of 24 hours. After the 24 hour exposure period, the skin was examined for erythema and oedema.
Results:
No erythema or oedema was observed at any concentration. Therefore, the 50 % (m/v) concentration was chosen for testing in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and dermal application)
- Site: back (surface: 4 x 6 cm²)
- Frequency of applications: three pairs of intradermal injections were given in the back region once and 6 days later the skin was treated with sodium lauryl sulfate 10 % in vaseline in order to induce a local irritatrion. 24 hours later the test item was topically applied using a patch-test technique. The patch (2 x 4 cm²) was soaked in the test item (saturated solution of the test item in a few drops of sesame oil), which was placed onto the shaved back of the animals. The patch was covered with a occlusive dressing.
- Concentrations:
Test animals:
Intradermal:
i) 0.1 mL FCA diluted 1:1 with aqua ad iniectabilia
ii) 0.1 mL test item in sesame oil (final concentration: 5 %)
iii) 0.1 mL test item in FCA mixed with aqua ad iniectabilia in the ratio 1:1 (final concentration: 5 %)
Topical application:
50 % concetration of test item
Control animals:
Intradermal injection:
i) 0.1 mL FCA diluted 1:1 with aqua ad iniectabilia
ii) 0.1 mL sesame oil
iii) 0.1 mL sesame oil and FCA/aqua ad iniectabilia (1:1) in the ratio 1:1
Topical application:
sesame oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (two weeks after the topical application (induction))
- Exposure period: 24 hours
- Site (test animals and controls): both flanks shaved; right flank: sesame oil; left flank: 50 % of the test item in sesame oil
- Evaluation (hr after challenge): 24 and 48 hours
OTHER OBSERVATIONS:
- mortality, clinical signs, and body weight (at the start of testing and at the end of testing) - Challenge controls:
- 5 guinea pigs were used as control animals.
Challenge dose: right flank: sesame oil; left flank: 50 % of the test item in sesame oil - Positive control substance(s):
- yes
- Remarks:
- Benzocaine (study conducted from 2002-04-12 to 2002-05-11; 10 test animals and 5 control animals; intradermal (induction): 5 %; topical (induction): 100 %; challenge: 100 %)
Results and discussion
- Positive control results:
- Animals treated with benzocaine in sesame oil exhibited a sensitising reaction in 6 of 10 animals in form of a discrete/patchy or moderate and confluent erythema (grades 1 and 2) 24 hours after administration. Furthermore, 4 of 10 animals exhibited discrete or patchy erythema (grade 1) 48 hours after administration.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No mortality, clinical signs or skin reactions were observed. No effect on body weight was observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No mortality, clinical signs or skin reactions were observed. No effect on body weight was observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No mortality, clinical signs, or skin reactions were observed. No effect on body weight was observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % test item
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No mortality, clinical signs, or skin reactions were observed. No effect on body weight was observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100 % concentration
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No mortality of clinical signs were observed. No effect on body weight was observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100 % concentration
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- No mortality of clinical signs were observed. No effect on body weight was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Regulation (EC) 1272/2008 and subsequent adaptations, the substance is not sensitising to the skin.
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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