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EC number: 810-816-6 | CAS number: 1473386-36-5
- 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:
shows a skin irritating potential (OECD 404) (BASF,2018)
does not show a skin irritation potential (EpiDerm™ skin corrosion/irritation test) (BASF,2014)
Eye irritation:
does not show an eye irritation potential (OECD 405) (BASF,2018)
does not show an eye irritation potential (EpiOcular) (BASF, 2014)
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Age at study initiation: Approx. 6 - 8 months
- Weight at study initiation: 3.40 - 4.01 kg
- Housing: single housing
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: al least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: untreated skin sites same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (2.5 cm x 2.5 cm) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1)
- Time after start of exposure: 4 h - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Considering the not fully reversible cutaneous reactions within the observation period as well as the average score for irritation, Heptadecyl Acrylate (C17A) shows a skin irritating potential under the test conditions chosen.
Reference
Readings |
Animal No. |
Erythema |
Edema |
Additional Findings |
0h |
1 |
2 |
0 |
Erythema beyond the application area
|
2 |
2 |
0 |
- |
|
1h |
1 |
2 |
1 |
Erythema and edema beyond the application area
|
2 |
2 |
0 |
- |
|
24h |
1 |
3 |
3 |
Erythema and edema beyond the application area
|
2 |
2 |
1 |
Erythema beyond the application area
|
|
48h |
1 |
4 |
3 |
Erythema and edema beyond the application area
|
2 |
3 |
1 |
Erythema beyond the application area
|
|
72h |
1 |
3 |
2 |
Erythema and edema beyond the application area
|
2 |
3 |
2 |
Erythema and edema beyond the application area
|
|
7d |
1 |
3 |
2 |
Erythema and edema beyond the application area, severe scaling
|
2 |
2 |
1 |
Severe scaling, Scaling,erythema and edema beyond the application are
|
|
14d |
1 |
3 |
1 |
Erythema and edema beyond the application area, severe sacaling
|
2 |
1 |
0 |
Scaling |
|
Mean 24h – 72h |
1 |
3.3 |
2.7 |
|
2 |
2.7 |
1.3 |
|
|
Mean |
- |
|
|
|
The cutaneous reactions were not reversible in both animals within 14 days after removal of the patch. On study day 14, moderate erythema (grade 3) and very slight edema (grade 1) beyond the application site and scaling was noted while the other animal showed very slight erythema (grade1) and scaling at study termination.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.46 kg - 2.53 kg
- Housing:single housing
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: alt least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: neagtive control: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of the animal(s) was rinsed with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, Heptadecyl Acrylate (C17A) does not show an eye irritating potential under the test conditions chosen.
Reference
|
|
Cornea |
Iris |
Conjunctiva |
|
|||
Readings |
Animal No. |
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
Additional Findings |
|
1 h |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
48 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
48 |
|
3 |
0 |
0 |
0 |
1 |
1 |
0 |
48 |
|
24 h |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
48, FL.neg. |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
FL.neg. |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
FL.neg. |
|
48 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
FL.neg. |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
FL.neg. |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
FL.neg. |
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
SD |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
SD |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
SD |
|
Mean 24h - 72 h |
1 |
0.0 |
- |
0.0 |
0.7 |
0.3 |
- |
|
2 |
0.0 |
- |
0.0 |
0.0 |
0.0 |
- |
|
|
3 |
0.0 |
- |
0.0 |
0.0 |
0.0 |
- |
|
|
Mean |
- |
0.0 |
- |
0.0 |
0.2 |
0.1 |
- |
|
48: scleral vessels injected, circumscribed area, central ingrown
FL.: fluorescein
neg.: negative
SD: study discontinued because the animal was free of findings
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity and for iris lesions, 0.7, 0.0 and 0.0 for redness of the conjunctiva and 0.3, 0.0 and 0.0 for chemosis.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
skin irritation:
in vivo:
The potential of C17 Acrylate (Heptadecyl Acrylate) to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 mL of the test item for 4 hours to the intact skin of two New Zealand White rabbits (stepwise procedure starting with one animal and supplementing one additional animal), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and at weekly intervals until day 14. Clinical observation are very slight to severe erythema (grade 1 to 4), very slight to moderate edema (grade 1 to 3), scaling to severe scaling and severe scaling, erythema and edema beyond the application area. The cutaneous reactions were not reversible in both animals within 14 days after removal of the patch (study termination). On study day 14, moderate erythema (grade 3) and very slight edema (grade 1) beyond the application site and scaling was noted in one animal while the other animal showed very slight erythema (grade1) and scaling. Mean scores over 24, 48 and 72 hours for each animal were 3.3 and 2.7 for erythema and 2.7 and 1.3 for edema. Considering the not fully reversible cutaneous reactions within the observation period as well as the average score for irritation, C 17 Acrylate (Heptadecyl Acrylate) shows a skin irritating potential under the test conditions chosen [BASF, 2018].
in vitro:
The potential of C17 Acrylate to cause dermal irritation was assessed by a single topical application of 30μL of the undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The EpiDerm skin irritation test showed the following results, the test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 103%. Based on the observed results and applying the evaluation criteria it was concluded, that C17 Acrylate does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen. [BASF, 2014]
eye irritation:
in vivo:
The potential of C17 Acrylate (Heptadecyl Acrylate) to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL volume of the undiluted test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Additional eye examinations were performed 24 and 48 h after application with the instillation of a fluorescein solution. Due to absence of detectable lesions following fluorescein instillation, all subsequent readings were performed without the aid of fluorescein. clinical observations were slight conjunctival redness, slight conjunctival chemosis and injected scleral vessels in a circumscribed area were noted in the animals at hour 1 and persisted in obe of these animals until hour 24. The ocular reactions were reversible in two animals within 24 hours and in one animal within 72 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity and for iris lesions, 0.7, 0.0 and 0.0 for redness of the conjunctiva and 0.3, 0.0 and 0.0 for chemosis. Considering the described ocular reactions as well as the average score for irritation, C17 Acrylate (Heptadecyl Acrylate) does not show an eye irritating potential under the test conditions chosen [BASF, 2018].
in vitro:
The potential of C17 Acrylate to cause ocular irritation was assessed by a single topical application of 50μL of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 102%. Based on the observed results and applying the evaluation criteria it was concluded, that C17 Acrylate does not show an eye irritation potential in the EpiOcular™eye irritation test under the test conditions chosen. [BASF, 2014].
Justification for classification or non-classification
Based on the available studies data on skin and eye irritating properties the test item would have to be classified and labelled as skin irrit. cat.2 (H315) according to according to Regulation (EC) No 1272/2008 (CLP).
Nevertheless, for the group of substances (monoalkyl or monoaryl or monoalkyaryl esters of acrylic acid) an entry in Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 exists which has to be adopted for heptadecyl acrylate although obtainded data show the opposite. Thus, the substance is classified as skin irrit. cat. 2 (H315, causes skin irritation), eye irrit. cat. 2 (H319, causes serious eye irritation) and as STOT SE cat. 3 (May cause respiratory irritation) according to Regulation (EC) No 1272/2008 (CLP).
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