Registration Dossier
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EC number: 402-170-5 | CAS number: 106359-91-5
- 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:
- guideline study
- Remarks:
- non GLP test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report Date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study has been performed in 1986 following the standards valid at that time
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): FAT 40'224/B
- Contents of active ingredients: a.i:80%
- Physical properties: powder; solubility in water >100g/L; pH: 6,5(lg/L water)
- Lot/batch No.: TZ 2382/8
- Validity: May 1987
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 LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 305 to 416 g
- Housing: The animals were housed individually in Macrolon cages (Type3).
- Diet (e.g. ad libitum): The animals received ad libitum standard guinea pig pellets - NAFAG No.846, Gossau SG.
- Water (e.g. ad libitum): Fresh water, ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal: NaCl; epicutaneous: vaseline
- Concentration / amount:
- First Induction intradermal application:
Concentration of FAT 40224/B in NaCl and adjuvant mixture: 1 %.
Second Induction, epidermal application:
Dose of application: approx. 0.4 g paste of 30 % FAT 40224/B in vaseline
Challenge
Dose of application : approx. 0.2 g paste of 10 % FAT 40224/B in vaseline.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal: NaCl; epicutaneous: vaseline
- Concentration / amount:
- First Induction intradermal application:
Concentration of FAT 40224/B in NaCl and adjuvant mixture: 1 %.
Second Induction, epidermal application:
Dose of application: approx. 0.4 g paste of 30 % FAT 40224/B in vaseline
Challenge
Dose of application : approx. 0.2 g paste of 10 % FAT 40224/B in vaseline.
- No. of animals per dose:
- 10/sex/dose
- Details on study design:
- A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
First Induction intradermal application:
Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test compound FAT 40224/B in NaCl
- test compound FAT 40224/B in the adjuvant saline mixture
Concentration of FAT 40224/B in NaCl and adjuvant mixture: 1 %.
Second Induction, epidermal application
One week later FAT 40224/B was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours). The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application). Dose of application: approx. 0.4 g paste of 30 % FAT 40224/B in vaseline
B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with FAT 40224/B in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours). Dose of application: approx. 0.2 g paste of 10 % FAT 40224/B in vaseline. The concentration of the test compound for the induction and challenge periods were determined on separate animals.
A control group 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 compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated
animals.
Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. The sensitizing potential of FAT 40224/B was classified according to the grading of Magnusson and Kligman. The body weight was recorded at start and end of the test. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- 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: negative control. 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:
- 20
- 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: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- 10%
- No. with + reactions:
- 17
- 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: 17.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test group
- Dose level:
- 10%
- No. with + reactions:
- 17
- 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: 17.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- 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: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- 0%
- 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: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test group
- Dose level:
- 0%
- 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: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the maximization grading the test substance showed an extreme grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs.
- Executive summary:
In a skin sensitization study, performed according to OECD guideline 406, Pirbright White strain guinea pigs were treated with test substance. The test was performed on 10 male and 10 female animals per group. The induction was a two-stage operation. For the first induction three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: 1) adjuvant and saline (1:1), 2) test substance in NaCl, 3) test substance in the adjuvant saline mixture. The concentration of test substance in NaCl and adjuvant mixture was 1 %. Second induction was performed one week later by epidermal application over the injection sites. The test substance was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (occluded administration for 48 hours). The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application). Dose of application was approx. 0.4 g paste of 30 % test substance in vaseline. Two weeks after the epidermal induction application the animals were tested on the flank with test substance in vaseline and the vehicle alone (occluded administration for 24 hours), approx. 0.2 g paste of 10 % test substance in vaseline. A control group 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 compound (at least 10 animals). Twenty four hours and 48 hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. Under the experimental conditions employed, 85 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. The test substance is, therefore, classified as an extreme sensitizer in albino guinea pigs according to the grading of Magnusson and Kligman.
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