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EC number: 203-378-7 | CAS number: 106-25-2
- 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
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- 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
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- Nanomaterial pour density
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- 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
In an in vivo irritation study on
rabbit skin according to the OECD Guideline 404 and in compliance with
GLP, nerol was irritating but non corrosive to the skin.
In an in vivo eye irritation study in rabbits, nerol showed slight signs of irritation not fully reversible at Day 7.
Therefore it was considered as irritating to eyes in a conservative approach.
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:
- 2 -9 July 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP study conducted according to OECD Guideline 404 with minor deviation: individual animal weights not reported.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Sandbach, UK.
- Age at study initiation: Approximately 12-16 weeks
- Weight at study initiation: 2.50-2.72 kg
- Housing: Animals were housed individually in suspended metal cages.
- Diet: Food (Rabbit diet, Preston Farmers Limited, New Leake, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-21 °C
- Humidity: 60-65 %
- Air changes: Approximately 15 changes/h
- Photoperiod: 12 h dark / 12 h light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h and 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal/flank area
- Type of wrap if used: Test item was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 25 mm x 40 mm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h
SCORING SYSTEM: According to OECD Guideline 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- - Very slight erythema was noted at one treated skin site one hour after removal of the patches.
- The irritation increased and very slight to well-defined erythema with or without very slight oedema was noted at all treated skin sites at subsequent 24, 48 and 72 h observations.
- Hyperkeratinisation of the skin was noted at all treated skin sites on Day 7.
- No corrosive effects were noted. - Other effects:
- None
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Nerol induced an hyperkeratinisation of the skin on Day 7. Based on the absence of information on the reversibility of this effect, this substance is classified as irritating to skin according to Directive 67/548/EEC and nerol is classified in Category 2 (irritant) according to CLP Regulation (EC) N° 1272/2008.
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand white rabbits were dermally exposed to 0.5 mL of nerol under a semi-occlusive dressing for 4 h. After removal of the residual test item, irritation was scored as outlined in OECD Guideline 404 at 1, 24, 48 and 72 h and 7 days after exposure.
Very slight erythema was noted at one treated skin site one hour after removal of the patches. The irritation increased and very slight to well-defined erythema with or without very slight oedema was noted in all treated skin sites at subsequent 24, 48 and 72 h observations. Hyperkeratinisation of the skin was noted in all treated skin sites on Day 7. No corrosive effects were noted. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1.7, 1.7, 2.0 for erythema and 0.7, 0.0, 0.7 for oedema score, respectively.
Thus, nerol induced an hyperkeratinisation of the skin on Day 7. Based on the absence of information on the reversibility of this effect, this substance is classified as irritating to skin according to Directive 67/548/EEC and nerol is classified in Category 2 (irritant) according to CLP Regulation (EC) N° 1272 /2008.
Reference
Table 7.3.1/1: Results of skin irritation
Skin reaction |
Reading (h) |
Individual scores – Rabbit no. |
||
90 |
119 |
124 |
||
Erythema/Eschar formation |
1 |
0 |
0 |
1 |
24 |
1 |
1 |
2 |
|
48 |
2 |
2 |
2 |
|
72 |
2 |
2 |
2 |
|
7 days |
H |
H |
H |
|
Mean (24, 48 and 72 h) |
1.7 |
1.7 |
2.0 |
|
Oedema formation |
1 |
0 |
0 |
0 |
24 |
0 |
0 |
1 |
|
48 |
1 |
0 |
1 |
|
72 |
1 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.7 |
0.0 |
0.7 |
H: Hyperkeratinisation over whole of test site
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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted similarly to OECD Guideline 405 with deviations: age and body weight of animals and details of lighting cycle of animal house not reported; identification data and physical nature/physiochemical properties of test item 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:
- age and body weight of animals and details of lighting cycle of animal house not reported; identification data and physical nature/physiochemical properties of test item not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Peter J. Flinn Rabbitry, Albany, USA.
- Housing: Animals were individually housed in stainless steel cages having a wire mesh floor measuring 16" x 19"
- Diet: Teklad rabbit feed, ad libitum
- Water: Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 % - 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:
- No washing was done.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- SCORING SYSTEM: Draize eye irritation procedure
- Irritation parameter:
- other: Eye irritation grade
- Basis:
- other: 6 animals
- Time point:
- other: Day 1
- Score:
- 31
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- other: Eye irritation grade
- Basis:
- other: 6 animals
- Time point:
- other: Day 2
- Score:
- 21
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- other: Eye irritation grade
- Basis:
- other: 6 animals
- Time point:
- other: Day 3
- Score:
- 15
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- other: Eye irritation grade
- Basis:
- other: 6 animals
- Time point:
- other: Day 4
- Score:
- 5
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- other: Eye irritation grade
- Basis:
- other: 6 animals
- Time point:
- other: Day 7
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Eye irritation was observed from Days 1 to 7, however complete reversibility was not observed at the end of observation.
- Other effects:
- No data.
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Nerol was irritating to eyes of female rabbits.
- Executive summary:
In an eye irritation study conducted similarly to OECD Guideline 405, 6 female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item, nerol, in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for several seconds to avoid any loss of test item. All eyes were examined at 24, 48 and 72 h and at 4 and 7 days after dosing and graded according to the Draize eye irritation procedure.
Eye irritation was observed from Days 1 to 7, however the complete reversibility was not observed at the end of observation. Eye irritation grade for 6 animals at days 1, 2, 3, 4 and 7 were 31, 21, 15, 5 and 1, respectively. Therefore, nerol is an eye irritant on female rabbits.
Therefore, as a conservative approach and as signs of irritation are not fully reversible at Day 7, nerol is classified as irritating to eyes according to Directive 67/548/EEC and nerol is classified in Category 2A according to CLP Regulation (EC) N° 1272 /2008.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits were dermally exposed to 0.5 mL of nerol under a semi-occlusive dressing for 4 h. After removal of the residual test item, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h and 7 days after exposure. Very slight erythema was noted at one treated skin site one hour after removal of the patches. The irritation increased and very slight to well-defined erythema with or without very slight oedema was noted at all treated skin sites at subsequent 24, 48 and 72 h observations. Hyperkeratinisation of the skin was noted at all treated skin sites on Day 7. No corrosive effects were noted. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1.7, 1.7, 2.0 for erythema and 0.7, 0.0, 0.7 for oedema score, respectively.
In an eye irritation study conducted similarly to the OECD Guideline 405, 6 female rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test item, nerol in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for several seconds to avoid any loss of test item. All eyes were examined at 24, 48 and 72 h and at 4 and 7 days after dosing and graded according to the Draize eye irritation procedure. Eye irritation was observed from Days 1 to 7, however the complete reversibility was not observed at the end of observation. Eye irritation grade for 6 animals at days 1, 2, 3, 4 and 7 were 31, 21, 15, 5 and 1, respectively. In this study, test item is an eye irritant on female rabbits. Under the test conditions, nerol is irritating to eyes of female rabbits.
Justification for selection of skin
irritation / corrosion endpoint:
Only one study available for this endpoint.
Justification for selection of eye irritation endpoint:
Only one study available for this endpoint.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
In an acute dermal toxicity study performed on rabbits with nerol, slight to moderate erythema and edema were noticed throughout the observation period (up to 7 days). Nerol induced an hyperkeratinisation of the skin on Day 7. Based on the absence of information on the reversibility of this effect, nerol is classified as irritating to skin according to Directive 67/548/EEC and nerol is classified in Category 2 according to CLP Regulation (EC) N° 1272/2008.
In an eye irritation study, nerol induced signs of ocular irritation in rabbits. However, the scale of score does not allow to compare these results with the classification criteria of Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008. Therefore, as a conservative approach and as signs of irritation are not fully reversible at Day 7, nerol is classified as irritating to eyes according to Directive 67/548/EEC and nerol is classified in Category 2A according to CLP Regulation (EC) N° 1272 /2008.
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