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Diss Factsheets
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EC number: 940-265-8 | 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:
- 1992-02-24 to 1992-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant; Guideline Study (OECD 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- April 25, 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Physical properties: powder;
- Storage conditions: room temperature;
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: not stated;
- Weight at study initiation: 346 - 425 g;
- Housing :individually in Macrolon cages (Type 3);
- Diet: standard guinea pig pellets - NAFAG No. 845, Gossau SG, ad libitum;
- Water: fresh water ad libitum;
- Acclimation period: 5 days;
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C,
- Humidity: relative humidity of 30 to 70%;
- Air changes (per hr): not stated;
- Light cycle: 12 hours light cycle/day;
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline (epidermal treatment); physiological saline ( intradermal treatment)
- Concentration / amount:
- Intradermal induction: 5 % in physiological saline;
Epidermal induction: 30 % of the test article in vaseline;
Epidermal challenge: 10 % of the test article in vaseline;
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline (epidermal treatment); physiological saline ( intradermal treatment)
- Concentration / amount:
- Intradermal induction: 5 % in physiological saline;
Epidermal induction: 30 % of the test article in vaseline;
Epidermal challenge: 10 % of the test article in vaseline;
- No. of animals per dose:
- 10 male/10 females in the test group;
5 males/5 females in the control group; - Details on study design:
- RANGE FINDING TESTS:
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of the test item have been examined on separate animals for the determination of the maximum subirritant concentration:
1, 5, 10, and 30% in vaseline.
The tested concentrations did not induce erythema reactions.
Because a higher concentration may lead to nonspecific reactions in adjuvant treated animals, the test article concentration of 10% in vasiline was chosen as subirritant for the challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE
First induction week, intradermal injection:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in physiological saline (w/v)
- test article in the adjuvant saline mixture (w/v)
Second induction week, epidermal application:
In the second week of induction the test item was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).
The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application).
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: during week 5
- Exposure period: 24 hours;
- Test groups: 10 males / 10 females;
- Control group: 5 males / 5 females;
- Site: flank
- Concentrations: 10 % in vaseline
- Evaluation (hr after challenge): 24 h; 48 h;
C. CONTROL GROUP
- A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals. - Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
- Positive control results:
- Results of the latest positive control test (perfomred every six months)
The following concentrations of the reference compound (potassium dichromate) and vehicles were used:
Intradermal induction: Concentration of compound: 0.2%, Vehicle: physiological saline
Epidermal induction: Concentration of compound: 5%, Vehicle: vaseline
Epidermal challenge: Concentration of compound: 1%, Vehicle: vaseline
Number of positive animals per group after occlusive epidermal application:
Control group: after 24 hours: vehicle control: 0/10; test article: 0/10; after 48 hours: vehicle control: 0/10; test article: 0/10;
Test group: after 24 hours: vehicle control: 0/10; test article: 7/10; after 48 hours: vehicle control: 0/10; test article: 6/10;
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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