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EC number: 264-761-2 | CAS number: 64265-45-8
- 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
Skin irritation
- Not irritating to skin; OECD TG 404 (RL1, GLP), in vivo, rabbit, 4 h, semiocclusive: edema & erythema scores 0/0/0
Eye irritation:
irritating to the eyes (Category 2); OECD TG 405 (RL1, GLP), in vivo, rabbit: cornea scores 1/1/1, iris scores 0.3/0.7/0.3, conjunctivae scores 2.7/3.0/2.7, chemosis scores 1.7/1.3/1.7
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:
- 2007-07-05 to 2007-07-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (K-H from SSNlFF® Spezialdiaten GmbH, Soest, Germany) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3 - 22.6°C
- Humidity (%): 45 - 68%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent areas of the untreated skin of each animal served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after removal of the test substance
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
The test substance was applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.
SCORING SYSTEM:
as stipulated in OECD TG 404 - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no evidence of a corrosive effect on the skin. No skin irritation was caused by 4 hours exposure to Amphopropionate C8.
- Other effects:
- No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study Amphopropionate C8 was not irritating/corrosive to the skin.
Mean erythema scores from observations at 24, 48 and 72 h after patch removal were 0 for 3/3 animals; mean edema scores were 0 for 3/3 animals. - Executive summary:
In a primary dermal irritation study according to OECD guideline 404 (2002) and EU method B.4 (2004) 3 young adult male New Zealand White rabbits were dermally exposed to 0.5 g of Amphopropionate C8 (97% a.i.) for 4 hours to 6 cm² body surface area. Animals then were observed for 72 hours. Irritation was scored according to the Draize scale as stipulated in the test guideline.
No skin irritation/corrosion was caused by 4 hours exposure to Amphopropionate C8. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Mean erythema and mean edema scores from observations at 24, 48 and 72 h after patch removal were 0 for 3/3 animals.
Based on these results, Amphopropionate C8 does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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:
- 2007-07-09 to 2007-09-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: >/= 9 weeks
- Weight at study initiation: 2.165 - 2.757 kg
- Housing: individually
- Diet (e.g. ad libitum): pelleted diet for rabbits (K-H from SSNIFF Spezialdiäten)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0±3 (actual range: 21.0-22.4°C)
- Humidity (%): 30-70 (actual range: 42-78%)
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item was instilled in the conjunctival sac of one eye
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 14 d
- Number of animals or in vitro replicates:
- 3 (started by treatment of a single rabbit (sentinel); the two other animals were treated 6 weeks later, after considering the degree of eye irritation observed in the first animal)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no; at the 24 h observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
SCORING SYSTEM: according to OECD TG 405 (Draize scale)
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, 3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- Instillation of 0.1 mL of the test item into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 75 or 50% of the corneal area). The corneal injury had resolved within 7 days. Iridial irritation grade 1 was observed and had resolved within 48 hours, 72 hours or 7 days. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days.
There was no evidence of ocular corrosion.
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this study, of Amphopropionate C8 (97% a.i.) is irritating to the eye (Category 2).
- Executive summary:
In a primary eye irritation study according to OECD Guideline 405 (2002) and EU method B.5 (2004) 0.1 mL of Amphopropionate C8 (97% a.i.) was instilled into the conjunctival sac of one eye of 3 male young adult New Zealand White rabbits. At the 24 h observation, a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
Instillation of 0.1 mL of the test item into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 75 or 50% of the corneal area). The corneal injury had resolved within 7 days. Iridial irritation grade 1 was observed and had resolved within 48 hours, 72 hours or 7 days. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days. There was no evidence of ocular corrosion.
In this study, Amphopropionate C8 (97% a.i.) is irritating to the eye (Category 2) based on conjunctival redness scores >/= 2.
Reference
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
1 h |
1/1/1 |
1/1/1 |
2/2/2 |
2/3/3 |
24 h |
1/1/1 |
0/1/1 |
2/3/2 |
2/2/3 |
48 h |
1/1/1 |
1/0/0 |
3/3/3 |
2/1/1 |
72 h |
1/1/1 |
0/1/0 |
3/3/3 |
1/1/1 |
Average 24h, 48h, 72h |
1/1/1 |
0.3/0.7/0.3 |
2.7/3.0/2.7 |
1.7/1.3/1.7 |
7 d |
0/0/0 |
0/0/0 |
1/2/1 |
0/1/0 |
14 d |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a primary dermal irritation study according to OECD guideline 404 (2002) and EU method B.4 (2004) 3 young adult male New Zealand White rabbits were dermally exposed to 0.5 g of Amphopropionate C8 (97% a.i.) for 4 hours to 6 cm² body surface area. Animals then were observed for 72 hours. Irritation was scored according to the Draize scale as stipulated in the test guideline.
No skin irritation/corrosion was caused by 4 hours exposure to Amphopropionate C8. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. Mean erythema and mean edema scores from observations at 24, 48 and 72 h after patch removal were 0 for 3/3 animals.
Based on these results, Amphopropionate C8 does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Eye irritation
In a primary eye irritation study according to OECD Guideline 405 (2002) and EU method B.5 (2004) 0.1 mL of Amphopropionate C8 (97% a.i.) was instilled into the conjunctival sac of one eye of 3 male young adult New Zealand White rabbits. At the 24 h observation, a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
Instillation of 0.1 mL of the test item into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 75 or 50% of the corneal area). The corneal injury had resolved within 7 days. Iridial irritation grade 1 was observed and had resolved within 48 hours, 72 hours or 7 days. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days. There was no evidence of ocular corrosion.
In this study, Amphopropionate C8 (97% a.i.) is irritating to the eye (Category 2) based on conjunctival redness scores >/= 2.
There are no data gaps for the endpoint irritation/corrosion. No human data are available. However, there is no reason to believe that these results from rabbit would not be applicable to humans.
Justification for classification or non-classification
Skin irritation
Based on reliable, adequate and relevant data, Amphopropionate C8 does not need to be classified for skin irritation according to regulation (EC) 1272/2008.
Eye irritation
Based on reliable, adequate and relevant data, Amphopropionate C8 is classified as Category 2 (Irritating to eyes) according to regulation (EC) 1272/2008 and labelled with H319: Causes serious eye irritation and the signal word “Warning”.
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