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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
- 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
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
- Study period:
- 1992-08-11 to 1993-01-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (OECD Guideline 406)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted on 17-Jul-1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 323 to 423 g
- Housing: individually in Macrolon cages
- Diet: ad libitum standard guinea pig pellets
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30 to 70%
- Photoperiod: 12 hrs light cycle - Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline, arachis oil, physiol. saline
- Concentration / amount:
- Intradermal Induction: test substance in arachis oil and adjuvant mixture: 5%
Epidermal Induction: test substance 50 % in vaseline
Epidermal Challenge: test substance 50 % in vaseline - Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline, arachis oil, physiol. saline
- Concentration / amount:
- Intradermal Induction: test substance in arachis oil and adjuvant mixture: 5%
Epidermal Induction: test substance 50 % in vaseline
Epidermal Challenge: test substance 50 % in vaseline - No. of animals per dose:
- test group: 10 male and 10 female guinea pigs
control group: 5 male and 5 female guinea pigs - Details on study design:
- RANGE FINDING TESTS
The concentration of the test compound for the induction and challenge periods were determined on four separate animals with concentrations of 1 %, 5 %, 10 %, 20%, 30% and 50%. The tested concentrations did not induce erythema reactions, therefore a concentration of 50% in vaseline was selected. No skin irritation was observed in the pretest. Therefore the application site was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. Concentration of test article for challenge was also 50% in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two-stage operation
- Exposure period: weeks 1 and 2
- Site: First, three pairs of intradermal injections into the neck region (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. Second, closed patch exposure over the injection sites one week later.
During weeks 3 and 4 no treatments were performed.
B. CHALLENGE EXPOSURE
- Exposure period: week 5
- Test and control groups: test substance in vaseline (w/w)
- Site: on the flank (occluded administration for 24 hrs) - Challenge controls:
- 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 article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- no
- Positive control results:
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test substance in vaseline
- 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: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% test substance in vaseline
- 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: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance in vaseline
- 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: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test substance in vaseline
- 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: 50% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
The test substance was investigated for its sensitizing potential in a Maximization test according to OECD guideline 406 and under GLP requirements (CIBA-GEIGY Ltd., 924086, 1993). Pirbright White guinea pigs received two intradermal induction treatments with 5% in arachis oil and one epicutanous induction treatment with 50% in vaseline. For each injection, three pairs (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. Control animals were treated equally with test substance replaced by the vehicle. Epidermal challenge was performed by occlusive application for 24 h two weeks later (50% in vaseline). No skin reactions were observed either for control or test group animals. The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate. In conclusion, the test substance is therefore not considered to be a skin sensitizer in albino guinea pigs and does not require classification.
Migrated from Short description of key information:
Skin sensitization (OECD 406 & GLP, maximization test): not sensitizing (guinea pig, in vivo) (CIBA-GEIGY Ltd., 924086, 1993)
Justification for selection of skin sensitisation endpoint:
GLP-compliant guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Respiratory sensitization
No data
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for sensitization is not warranted under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for sensitization is not warranted under Regulation (EC) No.1272/2008.
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