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EC number: 266-841-2 | CAS number: 67662-96-8
- 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
Pivarose was found to be not irritating to the skin and eyes of rabbits following application of the neat material.
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP study conducted similarly to OECD Guideline 404 with deviations: no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; occlusive patches were applied for 24 h and skin reactions were scored at 24 and 72 h after application; observations not followed until the reversibility of the effects
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- non-GLP study; no data about purity, no certificate of analysis of test substance; no details on environmental conditions; occlusive patches applied for 24 h and scored at 24 and 72 h after application; observations not followed until the reversibility
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: Adult
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact or abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 12 rabbits (6 with intact skin and 6 with abraded skin)
- Details on study design:
- - Area of exposure: Back of the animals
- % coverage: Test substance (0.5 mL) was applied under a surgical patch (1 inch x 1 inch) to the intact or abraded skin site on each animal.
- Type of wrap used: The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
REMOVAL OF TEST SUBSTANCE
- After an exposure period of 24 h, the patches and the applied material were removed.
SCORING SYSTEM:
- Skin reactions were scored at 24 and 72 h after application according to Draize scoring system (1944). - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 and 72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 and 72 h
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 5 animals
- Time point:
- other: 24 and 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 5 animals
- Time point:
- other: 24 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- - After 24 h, very slight erythema and very slight oedema was noted in animals.
- After 72 h, very slight or well-defined erythema, slight scaliness and very slight oedema were noted in 6/11 rabbits.
- No distinct differences were noted between the reactions on the intact skin and abraded skin. - Other effects:
- Mortality: One rabbit died during the exposure period, probably because of a mechanical trauma.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, fenethylpivalinate is not classified as irritating to skin according to the Directive 67/548/EEC and the CLP Regulation.
- Executive summary:
In a primary dermal irritation study performed similarly to OECD Guideline 404, 12 New Zealand White rabbits were dermally exposed to 0.5 mL of fenethylpivalinate, under an occlusive patch (1 inch X 1 inch) to intact or abraded skin of the dorsal region. After an exposure period of 24 h, the patches and the applied material were removed and skin reactions were scored by Draize method. A second reading was recorded 48 h later (72 h after application).
After 24 h, very slight erythema and very slight oedema was noted in animals. After 72 h, very slight or well-defined erythema, slight scaliness and very slight oedema were noted in 6/11 rabbits. No distinct differences were noted between the reactions on the intact skin and abraded skin.
The calculated mean scores for each individual lesion for all animals within two scoring times (24 and 72 h) were as follows: 0.83 for erythema score (intact skin), 0.25 for oedema score (intact skin); 0.80 for erythema score (abraded skin); 0.30 for oedema score (abraded skin).
Under these test conditions, fenethylpivalinate is not classified as irritating to skin according to the Directive 67/548/EEC and the CLP Regulation.
Reference
Table 7.3.1/1: Skin irritation data for individual rabbits
Rabbit number |
Irritation scores |
|||||
24 h |
72 h |
Mean (24 and 72 h) |
||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
Intact skin |
||||||
1 |
1 |
0 |
1 |
1 |
1 |
0.5 |
2 |
1 |
0 |
0 |
0 |
0.5 |
0 |
3 |
1 |
0 |
0 |
0 |
0.5 |
0 |
4 |
1 |
0 |
0 |
0 |
0.5 |
0 |
5 |
1 |
1 |
2 |
1 |
1.5 |
1 |
6 |
1 |
0 |
1 |
0 |
1 |
0 |
Mean (all 6 animals) |
0.83 |
0.25 |
||||
Abraded skin |
||||||
7 |
1 |
1 |
1 |
0 |
1 |
0.5 |
8 |
1 |
1 |
1 |
0 |
1 |
0.5 |
9 |
1 |
1 |
0 |
0 |
0.5 |
0.5 |
10 |
1 |
0 |
1 |
0 |
1 |
0 |
11 |
1 |
0 |
0 |
0 |
0.5 |
0 |
12 |
Dead |
- |
- |
|||
Mean (all 5 animals) |
0.80 |
0.30 |
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similarly to OECD Guideline 405 with deviations: no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; age of animals at the start of study not reported
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data about purity and no certificate of analysis of the test substance; no details on environmental conditions; age of animals at the start of study not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Housing: Animals were housed individually in cages.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were not washed following instillation and the animals were released immediately.
SCORING SYSTEM: Ocular lesions were scored at 24, 48 and 72 h after instillation according to a scale comparable to the OECD Guideline 405.
TOOL USED TO ASSESS SCORE: Ocular reactions were read using a binocular magnifying glass. The diagnosis of corneal damage was confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes were examined in a dark room under UV illumination. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0.28
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - Slight redness of the conjunctivae was noted in 4/6 rabbits.
- After three days, these lesions had cleared up completely. - Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, fenethylpivalinate is not classified as irritating to eyes according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).
- Executive summary:
In an eye irritation study conducted similarly to the OECD Guideline 405, six rabbits of the New Zealand White strain were exposed to 0.1 mL of fenethylpivalinate in one eye, while the other eye remained untreated and served as control. The eyelids were then gently held together for 1 second to avoid any loss of the test material. Eyes were not washed and ocular reactions were read at 24, 48 and 72 h following instillation using a binocular magnifying glass. The diagnosis of corneal damage was confirmed, if necessary, by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes were examined in a dark room under UV illumination. Ocular reactions were graded according to a scale comparable to the OECD Guideline 405.
Slight redness of the conjunctivae was noted in 4/6 rabbits. After three days, these lesions had cleared up completely. The calculated mean scores for each individual lesion for all animals within three scoring times (24, 48 and 72 h) were as follows: 0.00 for cornea score; 0.00 for iris score; 0.28 for conjunctivae score and 0.00 for chemosis score. In this study, fenethylpivalinate is not an eye irritant on rabbits.
Under the test conditions, fenethylpivalinate is not classified as irritating to eyes according to the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) N° 1272-2008 (CLP).
Reference
Table 7.3.2/1: Scores for ocular lesions
Animal no. |
Cornea |
Iris |
Conjunctivae redness |
Conjunctivae chemosis |
||||||||||||
24 h |
48 h |
72 h |
Mean* |
24 h |
48 h |
72 h |
Mean* |
24 h |
48 h |
72 h |
Mean* |
24 h |
48 h |
72 h |
Mean* |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
Mean# |
0 |
0 |
0.28 |
0 |
*mean of scores at 24, 48 and 72 h
#mean of scores of all 6 animals
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the results of a reliable in vivo skin and eye irritation study, classification under the EU DSD or CLP regulations as a skin or eye irritant is not required.
Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study
Justification for selection of eye irritation endpoint:
Reliable in vivo study
Justification for classification or non-classification
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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