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Diss Factsheets
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EC number: 204-524-2 | CAS number: 122-14-5
- 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
- Study period:
- No data (published article)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Allergic contact dermatitis from organophosphorus insecticides
- Author:
- Matsushita, T., Aoyama, K., Yoshimi, K., Fujita, Y., Ueda, A.
- Year:
- 1 985
- Bibliographic source:
- Industrial Health, 23, 145-153
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Maximisation
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Published literature study; performed prior to the adoption of OECD TG 429
Test material
- Reference substance name:
- Fenitrothion
- EC Number:
- 204-524-2
- EC Name:
- Fenitrothion
- Cas Number:
- 122-14-5
- Molecular formula:
- C9H12NO5PS
- IUPAC Name:
- O,O-dimethyl O-3-methyl-4-nitrophenyl phosphorothioate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Fenitrothion: no additional details reported
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5%
- Day(s)/duration:
- Not reported
- Adequacy of induction:
- not specified
- Route:
- other: dermal
- Vehicle:
- water
- Concentration / amount:
- 25%
- Day(s)/duration:
- Not reported
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: dermal
- Vehicle:
- water
- Concentration / amount:
- 0.5%, 5%
- Day(s)/duration:
- Not reported
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- 0.5% (challenge), 5% (intradermal induction and challenge) or 25% (dermal induction) fenitrothion in distilled water was applied. Induction and challenge were undertaken according to the original method. Skin reactions were observed 24 and 48 hours after removal of the patch, and the results were graded using a procedure by Kligman.
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not reported
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Summary of dermal reactions
Name |
Challenge concentration |
Response (%) |
|
|
24h |
48h |
|
Fenitrothion |
5% |
70 |
70 |
|
0.5% |
30 |
40 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results of this study (sensitisation of >=30% in response to an intradermal induction of >1.0%), fenitrothion is considered to be a moderate sensitiser and is classified as a skin sensitiser in Category 1B according to the CLP Regulation.
- Executive summary:
The skin sensitisation potential of fenitrothion was investigated in a published guinea pig Maximisation study. Groups of guinea pigs were induced using intradermal injection of 5% fenitrothion (in distilled water) and dermal application of 25% fenitrothion. All animals were subject to dermal challenge using 0.5% and 5% fenitrothion; dermal reactions were assessed at 24 and 48 hours following the challenge application. At 24 hours, positive responses were reported for 30% of the animals exposed to 0.5% fenitrothion and 70% of the animals exposed to 5% fenitrothion. At 48 hours, positive responses were reported for 40% of the animals exposed to 0.5% fenitrothion and 70% of the animals exposed to 5% fenitrothion. The study therefore indicates that fenitrothion is a skin sensitiser and requires classification as a skin sensitiser in Category 1B according to the CLP Regulation.
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