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EC number: 227-029-3 | CAS number: 5610-64-0 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15711.
- 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
Endpoint summary
Administrative data
Description of key information
OECD406, GPMT, not skin sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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:
- OECD guidelines for LLNA not available at the time of testing
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group,
respectively, initially weighing between 318 to 388 g.
The animals were housed i n d i v i d u a l l y in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+3°C, at a r e l a t i v e humidity of 30 to 70% and a 12 hours light cycle day. The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water.
All batches of the diet are assayed for n u t r i t i v e ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office. The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch"
(Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschütz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- Intradermal induction: 5% FAT40307/B in physiological saline (w/v)
5% FAT 40307/B in the adjjuvant/saline mixture (w/v)
Epidermal induction: 50% vaseline
Epidermal challenge: 30% vaseline
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 40307/B have been examined on separate animals for the determination of the maximum subirritant concentration:
10, 20, 30, and 50% in vaseline.
Erythema reactions were observed with 50% FAT 40307/B in vaseline. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- Intradermal induction: 5% FAT40307/B in physiological saline (w/v)
5% FAT 40307/B in the adjjuvant/saline mixture (w/v)
Epidermal induction: 50% vaseline
Epidermal challenge: 30% vaseline
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 40307/B have been examined on separate animals for the determination of the maximum subirritant concentration:
10, 20, 30, and 50% in vaseline.
Erythema reactions were observed with 50% FAT 40307/B in vaseline. - No. of animals per dose:
- 10 male and 10 female in the test group
5 male and 5 female in the control - Details on study design:
- 2.5. Auxiliary compounds
- Physiological saline (0.9 %), s t e r i l e solution (Hausmann, St. Gallen, Switzerland)
- Bacto Adjuvant, Complete, Freund (Difco Lab. Detroit, Michigan USA)
- Vaseline (white petrolatum) Ph, Zofingen, Switzerland) - Challenge controls:
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Interpretation of results:
- other: not classified unde Regulation 1272/2008
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested for skin sensitisation following OECD 406-Guinea Pig Maximisation Test. Under the experimental conditions the substance is not considered as skin sensitizer.
- Executive summary:
The substance was tested for skin sensitisation following OECD 406-Guinea Pig Maximisation Test.The induction was performed intradermal and epicutaneous with the help of an adjuvant at the dose of 50% in vaseline. Challenge was performed by occlusive epidermal application of a 30% concentration of the substance in vaseline. 10 females and 10 males were used as test group while 5 females and 5 males as control group. Challenge reactions were determined by scoring erythema and edema after 24 and 48 hours removal of the dressing. 10% and 5% of the animals showed positive response after 24 and 48h showing no potential to be a skin sensitizer.
Reference
The negative controlled was induced only with vehicle and challenged both with vehicle and the test article at the same concentration of the tes group
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study (Huntsman, 1993) on skin sensitisation following OECD 406-Guinea Pig Maximisation Test is available. Under the experimental conditions, 10% and 5% of the animals showed positive response after 24 and 48h, showing no potential to be a skin sensitizer,
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:
skin sensitizer Cat 1A, with GPMT:
≥ 30 % is responsive to ≤ 0,1 % of the intradermal induction dose or
> 60 % is responsive to > 0,1 %- ≤ 1 % of the intradermal induction dose
skin sensitizer Cat 1B, with GPMT
≥ 30 % to < 60 % is responsive to > 0,1 % - ≤ 1 % of the intradermal induction dose or,
≥ 30 % is responsive to > 1 % of the intradermal induction dose
Based on the results of the skin sensitization test (GPMT) the substance is not classified as skin sensitizer
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