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EC number: 448-250-3 | 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
Skin (OECD 404): not irritating (0.5 g, rabbit, semi-occlusive, 4 h)
Eye (OECD 405): not irritating (0.1 mL/15.8 – 17.7 mg, rabbit, single application without washing)
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:
- 12 Aug - 22 Aug 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- adopted August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), November 2000, including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: 1.465 - 1.515 kg
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany), approximately 100 g per day and pressed hay twice a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 23.9
- Humidity (%): 45 - 89
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: watery ethanol (50% v/v)
- Controls:
- other: not required, untreated site of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
(0.5 g test substance was moistened with 0.5 mL vehicle before application to ensure close contact to the skin) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
reading time points: 1, 24, 48 and 72 hours - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area, 6 cm²
- Type of wrap if used: metalline patch mounted on Micropore tape which is wrapped around the abdomen and secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed using water and ethanol
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all three animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all three animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The test substance resulted in very slight erythema in one animal (score of 1 at 1 hour reading after removal of the test substance) which was fully reversible within 24 hours.
- Other effects:
- No symptoms of toxicity and no staining of the skin by the test substance were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
Reference
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:
- 18 Aug - 28 Aug 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2012
- Deviations:
- yes
- Remarks:
- no anesthetics and systemic analgesics used
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), November 2000
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 1.651 - 1.785 kg
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany), approximately 100 g per day and pressed hay twice a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.4 - 22.2
- Humidity (%): 43 - 89
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required: the untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 16.8 mg (15.8 - 17.7 mg) (corresponding to a volume of approximately 0.1 mL) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 hours
reading time points: 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% fluorescein in water (pH 7.0) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Irritation of the conjunctivae was seen as redness, chemosis and discharge for all animals 1 hour after instillation. Redness was still visible 24 hours after instillation but was completely reversed thereafter. No iridial irritation or cornea opacity were observed. Treatment of the eyes with 2%
fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. - Other effects:
- No staining of ocular tissues by the test substance was observed.
Remnants of the test substance were present in the eyes of two animals and on the outside of the eyelid in one animal on day 1.
No mortality and no symptoms of systemic toxicity were observed. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
Reference
Table 1. Results of eye irritation study.
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
||
redness |
swelling |
redness |
swelling |
|||||||
1
|
1 |
2 |
1 |
0 |
0 |
|
||||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.3 |
0.0 |
0.0 |
0.0 |
Time to reversion |
48.0 |
24.0 |
0.0 |
0.0 |
|
2
|
1 |
1 |
1 |
0 |
0 |
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.3 |
0.0 |
0.0 |
0.0 |
Time to reversion |
48.0 |
24.0 |
0.0 |
0.0 |
|
3
|
1 |
2 |
1 |
0 |
0 |
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.3 |
0.0 |
0.0 |
0.0 |
Time to reversion |
48.0 |
24.0 |
0.0 |
0.0 |
|
|
|
|||||||||
|
Time [h] |
conjunctivae
|
iris |
cornea |
||||||
|
redness |
swelling |
|
|
avg. time to reversion |
48.0 |
24.0 |
0.0 |
0.0 |
|
average score |
1 |
1.67 |
1.00 |
0.00 |
0.00 |
|
||||
24 |
1.00 |
0.00 |
0.00 |
0.00 |
||||||
48 |
0.00 |
0.00 |
0.00 |
0.00 |
||||||
72 |
0.00 |
0.00 |
0.00 |
0.00 |
||||||
24+48+72 |
0.33 |
0.00 |
0.00 |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study assessing the skin irritation potential of 2-Hexyl-2 ‘-hydroxy-5 ‘methyldecananilide (AF-654) was performed according to OECD Guideline 404 (Hooiveld, 2003b). 0.5 g test substance was, due to its insolubility in water, moistened with watery ethanol (50% v/v) to ensure close contact with the skin, and applied sequentially to the clipped skin of New Zealand White rabbits under semi-occlusive conditions for 4 hours. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 hours after removal of the dressing. Exposure to the test substance resulted in very slight erythema (grade 1) in one animal at the 1-hour reading time point. The erythema had resolved within 24 hours. No staining of the treated skin by the test substance was noted.
In the acute dermal toxicity study, AF-654 was administered to rats in a limit test according to OECD Guideline 402 (van Otterdijk, 2004a). A single dose of 2000 mg/kg bw of the test substance (in propylene glycol) was applied to the clipped skin of rats (5 per sex) under occlusive conditions for 24 hours. White staining of the treated skin area was noted among 9/10 animals between Days 2 and 9. In addition, slight erythema (Days 2 and/or 3) or scales (between Days 3 and 12) classified as grade 1 were noted on the treated skin area of 2/5 and 1/5 females, respectively.
The skin irritation study, performed according to the standard test (OECD Guideline 404 with 4-hour exposure period under semi-occlusive conditions) did not result in skin irritation. The longer exposure period (24 hour) employed in the acute dermal toxicity study shows that even under more rigorous conditions the test substance does not cause skin irritation that leads to a classification. Therefore, 2-Hexyl-2 ‘-hydroxy-5 ‘methyldecananilide (AF-654) is considered not to be a skin irritant.
To evaluate the eye irritation potential of AF-654, a study was performed according to OECD Guideline 405 (Hooiveld, 2003c). 15.8 – 17.7 mg (weight corresponding to 0.1 mL) was instilled into one eye each of 3 New Zealand White rabbits, without washing. The other eye remained untreated and served as control. Remnants of the test substance were still observed in the eyes of 2/3 animals and outside the eye of 1/3 animals on Day 1 after instillation. The eyes were examined and scored 1, 24, 48 and 72 hours after the treatment. Instillation of the test substance resulted in irritation of the conjunctivae seen as redness, chemosis and discharge for 3/3 animals 1 hour after instillation. Redness (grade 1) was still visible 24 hours after instillation but had resolved completely within the 48-hour reading time point. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation, revealed no corneal epithelial damage in any of the animals. The mean score for conjunctivae after 24, 48, and 72 hours was 0.33 for all 3 animals. The effects on cornea, iris and chemosis after 24, 48, and 72 hours were scored 0 for 3/3 animals. Based on the results of this study, 2-Hexyl-2 ‘-hydroxy-5 ‘methyldecananilide (AF-654) is considered not to be an eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.
Justification for selection of eye irritation endpoint:
There is only one study available.
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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