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EC number: 604-714-9 | CAS number: 149968-48-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 December 2008 to 5 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study without any restriction
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Erucamidopropyl dimethylamine
- IUPAC Name:
- Erucamidopropyl dimethylamine
- Reference substance name:
- 13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-
- EC Number:
- 604-714-9
- Cas Number:
- 149968-48-9
- Molecular formula:
- not applicable (a generic molecular formula cannot be provided for this UVCB substance)
- IUPAC Name:
- 13-DOCOSENAMIDE, N-[3-(DIMETHYLAMINO)PROPYL]-, (13Z)-
- Test material form:
- other: solid, light beige
- Details on test material:
- - Storage condition of test material: at room temperature, light protected
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V, The Netherlands
- Age at study initiation: 16 weeks
- Weight at study initiation: 2437g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood Blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Klibba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): communitu tap water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music during the daytime period
IN-LIFE DATES: From: To: 24 to 31 December 2008
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g of the test item previsously grounded with a pestle and motar.
- Concentration (if solution): not applicable
VEHICLE
not applicable - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 2 days after the instillation
- Number of animals or in vitro replicates:
- One female.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No rinsing just after instillation was performed. The eye of the treated female was rinsed before the 24-hour examination to allow an assessment of the scores (this was prevented by the test item remnants present in the eye). The eye was also rinsed after the 48-hour reading. The lavage was performed with approximately 20 mL physiological saline.
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- for the treated female
- Time point:
- other: overall 24, 48h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- other: not assessed
- Remarks on result:
- other: animal killed for humane reason after the 48-hour examination
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- for the treated female
- Time point:
- other: overall 24, 48h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: not assessed
- Remarks on result:
- other: animal killed for humane reason after the 48-hour examination
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- for the treated female
- Time point:
- other: overall 24, 48h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: not assessed
- Remarks on result:
- other: animal killed for humane reason after the 48-hour examination
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- for the treated female
- Time point:
- other: overall 24, 48h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not assessed
- Remarks on result:
- other: animal killed for humane reason after the 48-hour examination
- Irritant / corrosive response data:
- A slight opacity of the cornea affecting the whole area was noted in the treated female at the 24-hour reading and progressed into moderate at the 48-hour evaluation. The light reflex was absent 24 to 48 hours after test item instillation. Moderate reddening and obvious swelling (chemosis) of the conjunctivae were noted 1 hour after treatment which progressed into marked reddening and marked swelling at the 24- and 48-hour reading. The sclerae of the animal were moderately reddened at the 1-hour observation and were not assessable 24 to 48 hours after treatment due to the swelling of the conjunctivae. Moderate ocular discharge was noted 1 to 48 hours after test item exposure. Blood was noted in the eye of the animal at the 48-hour evaluation.
See Table 7.3.2/1. - Other effects:
- The treated female showed uneven head and severe signs of pain during the examination of the eye at the 48-hour reading and was therefore sacrificed immediately thereafter. The treated female showed a slight body weight loss (-0.6%) between treatment and last observation day.
Any other information on results incl. tables
Table 7.3.2/1:Irritant/corrosive response data for the treated animal at each observation time up to removal of the animal from the test for ethical reason.
Score at time point / Reversibility |
Cornea |
Area of corneal opacity |
Iris |
Conjunctivae |
Chemosis |
Sclera |
Max. score: 4 |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
1h |
0 |
0 |
0 |
2 |
2 |
2 |
24 h |
2 |
4 |
2 |
3 |
4 |
n.a. |
48 h |
3 |
4 |
2 |
3 |
4 |
n.a. |
n.a. : not assessable due to swelling of the conjunctivae
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, considering the severity of the ocular observed effect in the treated female, Erucamidopropyl dimethylamine is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study performed according to the OECD guideline No. 405 / EU Method B.5, and in compliance with the GLP, 0.1 g of undiluted Erucamidopropyl dimethylamine (purity > 99%) was placed into the left eye of one New Zealand white female Rabbit. After the instillation the substance was not rinsed. Animals were then observed for eye edema and erythema of the conjunctive, corneal opacity and iris lesion.
Eye irritation was assessed and scored according to the Draize scale at 1, 24 and 48 hrs after the instillation of the substance. The treated female was killed for ethical reason after the 48-hour examination due to the severity of the ocular observed effects.
Indeed, a slight opacity of the cornea affecting the whole area was noted in the treated female at the 24-hour reading and progressed into moderate at the 48-hour evaluation. The light reflex was absent 24 to 48 hours after test item instillation. Moderate reddening and obvious swelling (chemosis) of the conjunctivae were noted 1 hour after treatment which progressed into marked reddening and marked swelling at the 24- and 48-hour reading. The sclerae of the animal were moderately reddened at the 1-hour observation and were not assessable 24 to 48 hours after treatment due to the swelling of the conjunctivae. Moderate ocular discharge was noted 1 to 48 hours after test item exposure. Blood was noted in the eye of the animal at the 48-hour evaluation.
Under the test conditions, Erucamidopropyl dimethylamine is classified as Eye Dam. 1 (H318) according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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