Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Guideline-compliant studies of skin corrosion/irritation and eye irritation in the rabbit are available for fenitrothion.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 December 2009 - 12 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Fenitrothion TG
Reddish/yellow oily liquid
Lot No.: 070502
Purity: 95.1% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labs, Japan
- Age at study initiation: 11 weeks
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 5 January 2010 To: 8 January 2010 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- 0.5 mL of the test material was applied to the clipped dorsal skin of three rabbits for 4 hours under semi-occlusive conditions. Exposure was terminated by washing the remaining test material from the application site with acetone. Local dermal reactions were scored at 24, 48 and 72 hours after removal of the dressing.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no evidence of local dermal irritation at the application site in any rabbit at any time point.
- Other effects:
- There were no signs of toxicity.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no evidence of local dermal irritation at the application site in any rabbit at any time point; fenitrothion does not therefore require classification for skin corrosion or skin irritation according to the CLP criteria.
- Executive summary:
The skin irritation potential of fenitrothion was investigated in a rabbit study according to OECD 404. 0.5 mL fenitrothion was applied to the clipped dorsal skin of three rabbits for 4 hours under semi-occlusive conditions. Exposure was terminated by washing the remaining test material from the application site. Local dermal reactions were scored at 24, 48 and 72 hours after removal of the dressing. There was no evidence of local dermal irritation at the application site in any rabbit at any time point; fenitrothion does not therefore require classification for skin corrosion or skin irritation according to the CLP criteria.
Reference
Mean scores for irritation
|
24h |
48h |
72h |
Mean (24-72h) |
Erythema |
0.00 |
0.00 |
0.00 |
0.00 |
Oedema |
0.00 |
0.00 |
0.00 |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 December 2009 - 12 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Fenitrothion TG
Reddish/yellow oily liquid
Lot No.: 070502
Purity: 95.1% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayam Labs
- Age at study initiation: 11 weeks
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 4 January 2010 To: 7 January 2010 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Not applicable: the treated eyes were unwashed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 0.1 mL of the test material was instilled into one eye of three rabbits. Ocular reactions were scored at 11, 24, 48 and 72 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point. All reactions had resolved by 48 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point. All reactions had resolved by 48 hours. The reactions are not sufficient to trigger classification for serious eye damage or serious eye irritation according to the CLP criteria.
- Executive summary:
The eye irritation potential of fenitrothion was investigated in a rabbit study performed in compliance with OECD 405. 0.1 mL of the test material was instilled into one eye of three rabbits' ocular reactions were scored at 11, 24, 48 and 72 hours. Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point. All reactions had resolved by 48 hours. The reactions seen in this study are not sufficient to trigger classification for serious eye damage or serious eye irritation according to the CLP criteria.
Reference
Summary of ocular reactions
|
24h |
48h |
72h |
Mean (24-72h) |
Cornea |
0.00 |
0.00 |
0.00 |
0.00 |
Iris |
0.00 |
0.00 |
0.00 |
0.00 |
Erythema |
0.33 |
0.00 |
0.00 |
0.11 |
Chemosis |
0.33 |
0.00 |
0.00 |
0.11 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of fenitrothion was investigated in a rabbit study according to OECD 404. 0.5 mL fenitrothion was applied to the clipped dorsal skin of three rabbits for 4 hours under semi-occlusive conditions. Exposure was terminated by washing the remaining test material from the application site. Local dermal reactions were scored at 24, 48 and 72 hours after removal of the dressing. There was no evidence of local dermal irritation at the application site in any rabbit at any time point; fenitrothion does not therefore require classification for skin corrosion or skin irritation according to the CLP criteria.
The eye irritation potential of fenitrothion was investigated in a rabbit study performed in compliance with OECD 405. 0.1 mL of the test material was instilled into one eye of three rabbits' ocular reactions were scored at 11, 24, 48 and 72 hours. Signs of irritation were limited to Grade 1 conjunctival erythema and Grade 1 chemosis in one rabbit at the 24-hour observation point. All reactions had resolved by 48 hours. The reactions seen in this study are not sufficient to trigger classification for serious eye damage or serious eye irritation according to the CLP criteria.
There are no studies of respiratory irritation; however the lack of skin and eye irritation and the absence of relevant signs in the acute inhalation toxicity study indicate that fenitrothion is unlikely to be a respiratory irritant.
Justification for classification or non-classification
Fenitrothion has a harmonised classification under CLP and is not classified as a skin or eye irritant. The results of the available studies are consistent with the harmonised classification; no change is therefore proposed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.