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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
Endpoint summary
Administrative data
Description of key information
Two guinea pig studies of skin sensitisation are available for fenitrothion.
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:
- No data (published article)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- 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
- Specific details on test material used for the study:
- Fenitrothion: no additional details reported
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- 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
- 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
- Positive control results:
- Not reported
- 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
- 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1 July 1972 - 20 August 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Sacchuzai Shi-shin (Guideline for toxicity testing of insecticides for sanitary use, Japan) equivalent to Landsteiner-Draize’s method
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- other: Landsteiner-Draize method
- Justification for non-LLNA method:
- The study was performed prior to the development and adoption of the LLNA
- Specific details on test material used for the study:
- Fenitrothion
Batch No.: 417
Purity: 97.2% - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Nihon Dobutsu Co., Osaka
- Weight at study initiation: 250-300 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-27
- Humidity (%): 50-70 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1 mL of a 1% or 5% solution
- Day(s)/duration:
- Ten injections, on alternate days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 0.05 mL by intradermal injection or 0.03 mL dermal application; 1% or 5% solution
- Day(s)/duration:
- Single exposure
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 6
- Details on study design:
- 0.1 ml of a 1% or 5% solution of fenitrothion in corn oil was injected intradermally to the back of animals, every other day for a total of 10 injections (except that 0.05 ml was used in the first sensitizing treatment). Two weeks after the last sensitizing injection, each animal was challenged by intradermal injection (0.05 ml) and dermal application (0.03 ml) of the same concentration as used for sensitizing injections. As a positive control, 0.1 ml of 0.05% DNCB (2,4-dinitrochlorobenzene) dissolved in corn oil was treated in the same way as fenitrothion, except that the sensitizing treatments were conducted 3 times every other day. The animals were challenged with 0.1% DNCB (intradermal injection), 0.3% (dermal application) and 1.0% (dermal application) as in the treated groups. Three negative control groups received corn oil as induction treatment. The animals were challenged with 5% fenitrothion (intradermal injection and dermal application), corn oil (intradermal injection), or DNCB (0.1%; intradermal injection, 1%; dermal application) as in the treated groups.
- Challenge controls:
- Corn oil
- Positive control substance(s):
- yes
- Remarks:
- DNCB
- Positive control results:
- In the animals sensitized and challenged with DNCB (intradermal injection or dermal application), haemorrhage and oedema were observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- DNCB, 1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no evidence of skin sensitisation in this study; fenitrothion is not therefore classified as a skin sensitiser on the basis of this study.
- Executive summary:
The skin sensitisation potential of fenitrothion was investigated in a guinea-pig study following the Landsteiner-Draize method. 0.1 ml of a 1% or 5% solution of fenitrothion in corn oil was injected intradermally to the back of animals, every other day for a total of 10 injections (except that 0.05 ml was used in the first sensitizing treatment). Two weeks after the last sensitizing injection, each animal was challenged by intradermal injection (0.05 ml) and dermal application (0.03 ml) of the same concentration as used for sensitizing injections. As a positive control, 0.1 ml of 0.05% DNCB (2,4-dinitrochlorobenzene) dissolved in corn oil was treated in the same way as fenitrothion, except that the sensitizing treatments were conducted 3 times every other day. The animals were challenged with 0.1% DNCB (intradermal injection), 0.3% (dermal application) and 1.0% (dermal application) as in the treated groups. Three negative control groups received corn oil as induction treatment. The animals were challenged with 5% fenitrothion (intradermal injection and dermal application), corn oil (intradermal injection), or DNCB (0.1%; intradermal injection, 1%; dermal application) as in the treated groups. In the animals sensitized and challenged with DNCB (intradermal injection or dermal application), haemorrhage and oedema were observed. There was no evidence of skin sensitisation in this study. Findings of swelling and slight hyperaemia seen following intradermal challenge with 5% fenitrothion were considered to be due to primary irritation. Fenitrothion is not therefore classified as a skin sensitiser on the basis of this study.
Referenceopen allclose all
Summary of dermal reactions
Name |
Challenge concentration |
Response (%) |
|
|
24h |
48h |
|
Fenitrothion |
5% |
70 |
70 |
|
0.5% |
30 |
40 |
Summary of dermal reactions
Group |
A |
B |
C1 |
C2 |
C3 |
C4 |
D1 |
D2 |
D3 |
|
Induction: |
Fenitrothion |
Fenitrothion |
Corn oil |
DNCB
|
||||||
Challenge: |
Fenitrothion |
Fenitrothion |
Corn oil |
Fenitrothion |
DNCB
|
DNCB
|
||||
Concentration (%) |
1 |
5 |
- |
5 |
0.1 |
1 |
0.1 |
0.3 |
1 |
|
Number of animals used |
6 |
6 |
3 |
3 |
3 |
3 |
5 |
5 |
5 |
|
Reactions |
- |
6/6 |
1/6 |
3/3 |
0/3 |
1/3 |
|
0/5 |
|
|
(intradermal |
± |
0/6 |
5/6 |
0/3 |
3/3 |
2/3 |
|
0/5 |
|
|
injection) |
+ |
0/6 |
0/6 |
0/3 |
0/3 |
0/3 |
|
3/5 |
|
|
|
++ |
0/6 |
0/6 |
0/3 |
0/3 |
0/3 |
|
2/5 |
|
|
|
+++ |
0/6 |
0/6 |
0/3 |
0/3 |
0/3 |
|
0/5 |
|
|
Reactions |
- |
6/6 |
6/6 |
|
3/3 |
|
3/3 |
|
0/5 |
0/5 |
(dermal |
± |
0/6 |
0/6 |
|
0/3 |
|
0/3 |
|
0/5 |
0/5 |
application) |
+ |
0/6 |
0/6 |
|
0/3 |
|
0/3 |
|
0/5 |
0/5 |
|
++ |
0/6 |
0/6 |
|
0/3 |
|
0/3 |
|
3/5 |
0/5 |
|
+++ |
0/6 |
0/6 |
|
0/3 |
|
0/3 |
|
2/5 |
5/5 |
-: No sign
±: Very slight swelling and erythema
+: Slight swelling and hyperaemia,
++: Moderate swelling and hyperaemia
+++: Severe swelling and hyperaemia
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
An older non-guideline study reports a negative result; a published Maximisation assay reports a positive result.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Fenitrothion has a harmonised classification under CLP and is not classified as a skin sensitiser. The results of the key (Maximisation) study indicates a potential for skin sensitisation; therefore classification for skin sensitisation is proposed for fenitrothion. Based on the results of the key 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.
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.
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