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EC number: 944-011-7 | CAS number: -
- 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
Under the test conditions for skin irritation, PM 343 is classified as ‘Category 2: Irritant’ according to the CLP Regulation and as ‘R38 Irritating to skin’ according to the Directive 67/548/EEC.
Under the test conditions for eye irritation, PM 343 Pivaloxycyclene is classified as ‘Irritating to eyes (Category 2)’ according to the CLP Regulation. It is not classified as irritating to eyes according to the Directive 67/548/EEC.
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:
- 1979-05-21 to 1979-06-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- 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 housing conditions of animals; observations not followed until the reversibility of the effects; different scoring system was followed in the 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 and no certificate of analysis of the test substance; no details on housing conditions of animals; observations not followed until the reversibility of the effects; different scoring system was followed in the study
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): PM 343
- Source: PPL, UK
- Physical state: Clear liquid
- Date received: 29 March 1979 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 9-12 weeks
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- Eight
- Details on study design:
- - Area of exposure: Dorsum
- % coverage: Test substance (0.5 mL) was applied under a semi-occlusive patch to the clipped skin and the patches were held in place with an adhesive tape.
- Type of wrap used: Animals were immobilised in a canvas body sleeve for 4 h after application of the patch.
REMOVAL OF TEST SUBSTANCE
- After the removal of the patches, the application site was wiped clean of excess material.
SCORING SYSTEM: Skin reactions were observed immediately after removal of the patch and after 24, 48 and 72 h and graded according to the following 8-point anchored ordinate scale:
1 = marginal / very slight
2 = slight
3 = fairly distinct
4 = quite distinct
6 = becoming well developed
8 = well developed
10 = becoming severe
12 = severe - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 3.4
- Max. score:
- 12
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: average of 24, 48 and 72 h
- Score:
- 2.8
- Max. score:
- 12
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- other: sum of scores observed in 8 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 225
- Max. score:
- 1 152
- Reversibility:
- no data
- Irritant / corrosive response data:
- - At 24 h, generally fairly distinct to distinct erythema and oedema were noted in test animals.
- By 48 and 72 h, fairly distinct to distinct erythema and slight to fairly distinct oedema with marginal to slight cracking were noted in most animals.
- The response produced by PM 343 was greater than that produced by Diethyl Phthalate which produced a generally marginal to slight response in some animals, although one animal had distinct erythema and oedema at 24 h.
- The response produced by PM 343 was slightly less than that produced by the controls, Cyclamen Aldehyde and Geraniol, which produced similar responses showing fairly distinct to fairly well developed erythema and oedema at 24 h and fairly distinct to well-developed erythema and oedema with slight cracking in some animals by 48 and 72 h. - Other effects:
- None
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Under the test conditions, PM 343 is classified as ‘Category 2: Irritant’ according to the CLP Regulation and as ‘R38 Irritating to skin’ according to the Directive 67/548/EEC.
- Executive summary:
In a primary dermal irritation study performed similarly to OECD Guideline 404, 0.5 mL of the test item, PM 343, was applied under a semi-occlusive patch to clipped dorsum of eight New Zealand White rabbits. After an exposure period of 4 h, the patches and the applied material were removed and skin reactions were scored immediately after removal of the patch and after 24, 48 and 72 h, according to the 8-point anchored ordinate scale ranging from very slight (score = 1) to severe reactions (score = 12).
At 24 h, generally fairly distinct to distinct erythema and oedema were noted in test animals. By 48 and 72 h, fairly distinct to distinct erythema and slight to fairly distinct oedema with marginal to slight cracking were noted in most animals. Very slight scaling was noted in 3/8 animals at 72 h. The calculated mean scores for each individual lesion for all animals within three scoring times (24, 48 and 72 h) on the 8-point anchored ordinate scale were 3.4 for erythema score and 2.8 for oedema score.
After comparing the scores with the scale in OECD Guideline, the calculated mean scores for all animals within three scoring times (24, 48 and 72 h) were as follows: 2 for erythema score and 2 for oedema score.
Under the test conditions, PM 343 is classified as ‘Category 2: Irritant’ according to the CLP Regulation and as ‘R38 Irritating to skin’ according to the Directive 67/548/EEC.
Reference
Table 7.3.1/1: Skin irritation data for individual rabbits
Rabbit number |
Irritation scores* |
|||||||
24 h |
48 h |
72 h |
Mean (24, 48 and 72 h) |
|||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 |
3# |
3 |
3# |
2 |
3# α |
2 |
3.0 |
2.3 |
2 |
4 |
3 |
4# |
3 |
3# |
2 |
3.7 |
2.7 |
3 |
4 |
3 |
3# |
3 |
3# |
2 |
3.3 |
2.7 |
4 |
2 |
2 |
3# |
2 |
2# |
1 |
2.3 |
1.7 |
5 |
4 |
3 |
4 |
4 |
4# α |
4 |
4.0 |
3.7 |
6 |
4 |
4 |
4 |
3 |
3# |
3 |
3.7 |
3.3 |
7 |
4# α |
4 |
4# α |
2 |
3# α |
2 |
3.7 |
2.7 |
8 |
4 |
3 |
4 |
3 |
3# |
3 |
3.7 |
3.0 |
Mean (all 8 animals) |
3.4 |
2.8 |
*Reaction grades and scores:
1 = marginal / very slight
2 = slight
3 = fairly distinct
4 = quite distinct
6 = becoming well developed
8 = well developed
10 = becoming severe
12 = severe
#Very slight to fairly distinct cracking
αVery slight scaling
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 1979-05-21 to 1979-06-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non-GLP 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- non-GLP study; no data about purity and no certificate of analysis of the test substance; no details on environmental conditions
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): PM 343 Pivaloxycyclene
- Source: PPL, UK
- Physical state: Very pale clear yellow liquid
- Date received: 29 March 1979 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Age at study initiation: 8 weeks
- Weight at study initiation: 1-2 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 15 days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Ocular lesions were scored at 15 min, 4, 24, 48 and 72 h and on Days 5, 8, 9, 10, 11, 12 and 15 according to the following scale:
CORNEA
Normal……0
Any change from normal, including slight dulling of corneal luster.......0.5 (can be considered as equivalent to 1 as recommended in OECD Guideline 405)
Scattered or diffuse areas of opacity, or loss of corneal epithelium, iris clearly visible….…1
Easily discernible, greyish, translucent areas, details of iris slightly obscured….…2
Grey-white areas, no details of iris visible, size of pupil barely discernible……..3
Complete corneal opacity, iris not discernible…..…4
IRIS
Normal…0
Any divergence from normal, congestion of iridial vessels, deepening on folds……+ (can be considered as equivalent to 1 as recommended in OECD Guideline 405)
CONJUNCTIVAE
Redness (palpebral and bulbar conjunctivae and nictitating membrane)
Vessel normal……0
Some vessel definitely injected……1
Diffusion, crimson red, individual vessel not easily discernible……2
Diffuse beefy red……3
CHEMOSIS
No swelling……0
Any swelling above normal……1
Obvious swelling with partial eversion of eyelids……2
Swelling with lids about half closed…..…3
Swelling with lids more than half closed………4
TOOL USED TO ASSESS SCORE: Slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: for undiluted test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: for undiluted test item
- Irritant / corrosive response data:
- - Moderate corneal opacities, affecting up to all cornea, were noted in all 3 rabbits. These reactions were associated with moderate corneal swelling.
- All animals had slight to moderate conjunctivitis and 2/3 animals had slight to moderate discharge.
- One animal healed by Day 4, one by Day 9 and one by Day 15. - Other effects:
- None
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, PM 343 Pivaloxycyclene is classified as ‘Irritating to eyes (Category 2)’ according to the CLP Regulation. It is not classified as irritating to eyes according to the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study conducted similarly to the OECD Guideline 405, 0.1 mL of the undiluted test item, PM 343 Pivaloxycyclene, was instilled into one eye of 3 rabbits. The eyes were examined and the changes were scored at 15 min, 4, 24, 48 and 72 h and on Days 5, 8, 9, 10, 11, 12 and 15.
Single application of the undiluted preparation caused moderate corneal opacities, affecting up to all cornea, in all 3 rabbits. These reactions were associated with moderate corneal swelling. All animals had slight to moderate conjunctivitis and 2/3 animals had slight to moderate discharge. One animal healed by Day 4, one by Day 9 and one by Day 15. Mean individual scores at 24, 48 and 72 h for the 3 animals after exposure to undiluted item were 1.0, 0.7, 1.0 for cornea score; 0, 0, 0 for iris score; 1.3, 0.7, 0.7 for conjunctivae score and 0.3, 0.3, 0.3 for chemosis score.
Under the test conditions, PM 343 Pivaloxycyclene is classified as ‘Irritating to eyes (Category 2)’ according to the CLP Regulation.
Reference
Table 7.3.2/1: Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 h) after instillation of undiluted test item
Rabbit No. |
Region of eye |
Scores |
|||||||||
15 min |
4 h |
24 h |
48 h |
72 h |
Day 5 |
Day 8 |
Days 9-12 |
Day 15 |
Mean |
||
(24, 48 and 72 h) |
|||||||||||
1 |
Corneal opacity |
- |
- |
1 |
1 |
1 |
1 |
- |
1 |
N |
1.0 |
Iris |
- |
- |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Conjunctivae: Redness |
1 |
1 |
1 |
2 |
1 |
1 |
- |
0 |
0 |
1.3 |
|
Conjunctivae: Chemosis |
0 |
0 |
1 |
0 |
0 |
0 |
- |
0 |
0 |
0.3 |
|
2 |
Corneal opacity |
- |
- |
1 |
1 |
N |
- |
- |
- |
- |
0.7 |
Iris |
- |
- |
0 |
0 |
0 |
- |
- |
- |
- |
0.0 |
|
Conjunctivae: Redness |
1 |
1 |
1 |
1 |
0 |
- |
- |
- |
- |
0.7 |
|
Conjunctivae: Chemosis |
0 |
1 |
1 |
0 |
0 |
- |
- |
- |
- |
0.3 |
|
3 |
Corneal opacity |
- |
- |
1 |
1 |
1 |
- |
N |
- |
- |
1.0 |
Iris |
- |
- |
0 |
0 |
0 |
- |
0 |
- |
- |
0.0 |
|
Conjunctivae: Redness |
1 |
1 |
1 |
1 |
0 |
- |
0 |
- |
- |
0.7 |
|
Conjunctivae: Chemosis |
0 |
1 |
1 |
0 |
0 |
- |
0 |
- |
- |
0.3 |
N: No information about the symbol was reported by the author. In the text, it was mentioned that one animal healed by Day 4, one by Day 9 and one by Day 15 therefore 'N' was considered as equivalent to zero for the calculation of mean scores.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable in vivo study
Justification for selection of eye irritation endpoint:
Reliable in vivo study
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results of reliable in vivo skin and eye irritation studies, Pivacyclene is classified as a ‘Category 2: Irritant’ and ‘Irritating to eyes (Category 2)’ according to the EU DSD or CLP Regulation.
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