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EC number: 947-387-0 | 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
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of N-[3-(Dimethylamino)propyl]stearamide and N-[3-(Dimethylamino)propyl]hexadecan-1-amide
- Molecular formula:
- Not relevant
- IUPAC Name:
- Reaction mass of N-[3-(Dimethylamino)propyl]stearamide and N-[3-(Dimethylamino)propyl]hexadecan-1-amide
- Test material form:
- solid
- Details on test material:
- Test material: DMAPSA (Octadecanamide, N-(3-(dimethylamino)propyl)-) (CAS No. 7651-02-7).
Date of receipt: 24th July 1990.
Description: White waxy solid.
Storage: In original container at room temperature.
Constituent 1
- Specific details on test material used for the study:
- Test material: DMAPSA (Octadecanamide, N-(3-(dimethylamino)propyl)-) (CAS No. 7651-02-7).
Date of receipt: 24th July 1990.
Description: White waxy solid.
Storage: In original container at room temperature.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.14 kg
- Housing: The animal was housed in a suspended metal cage
- Diet and water (e.g. ad libitum): Free access to mains drinking water and food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.) was allowed throughout the study.
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 62-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (corresponding to 64.3 mg)
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1 & 24h
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- SCORING SYSTEM:
grades of Drajze J.H. (1959)
TOOL USED TO ASSESS SCORE: Examinat'ion of the eye was facilitated by use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: The animal showed signs of pain and discomfort 24-h after treatment and therefore was kiIIed in accordance with Home Office Guidelines
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: The animal showed signs of pain and discomfort 24-h after treatment and therefore was kiIIed in accordance with Home Office Guidelines
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 3
- Reversibility:
- other: The animal showed signs of pain and discomfort 24-h after treatment and therefore was kiIIed in accordance with Home Office Guidelines
- Remarks on result:
- other: unable to score for redness due to white appearance of the conjunctival and nictitating menbranes.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: The animal showed signs of pain and discomfort 24-h after treatment and therefore was kiIIed in accordance with Home Office Guidelines
- Irritant / corrosive response data:
- Diffuse corneal opacity, iridial inflammation and severe conjunctìval irritation were observed within 24 hours following treatment. In addition sloughing of the conjunctival and nictitating membrane, haemorrhage of the conjunctivaì membrane, blood stained discharge and a white appearance of the nictitating and conjunctival membrane were observed.
Twenty-four hours after treatment the animal showed signs of pain and discomfort and therefore was kiIIed in accordance with Home Office Guidelines.
Any other information on results incl. tables
Individual scores are provided below for eye irritation
Time after treatment |
1h |
24h |
Cornea |
||
E = degree of opacity |
d |
3 |
F = area of oapacity |
4 |
4 |
Score (ExF)x5 |
0 |
60 |
Iris |
||
D |
1 |
1 |
Score (Dx5) |
5 |
5 |
Conjunctivae |
||
A = Redness |
2 |
? SLHW |
B = Chemosis |
3 |
4 |
C = Discharge |
3 |
3 BL |
Score (A+B+C)x2 |
16 |
14-20 |
Total score |
21 |
79-85 |
D = dulling of the normal lustre of the corneal surface
BL = blood stained discharge
SL = sloughing of the conjunctival and nictitating membranes
H = haemorrhage of the conjunctival membrane
W = nictitating and conjunctival membranes white in appearance
? = unable to score for redness due to white appearance of the nictitating and conjunctival membranes
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material, DMAPSA, was regarded as at least a severe irritant to the rabbit eye (based on one rabbit only).
The test material, DMAPSA, was also considered as a severe irritant to the rabbit eye according to EEC Iabelling regulations.
It is reasonable to assume the symbol "Xi" and highest risk phrase R 41 "RISK 0F SERI0US DAMAGE T0 EYES" are therefore required. - Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand tlhite rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals
(1987) N0.405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 67/548/EEC. The results may be used as a basis for classification and labelling under Commission Directive 83/467/EEC and the U.K. Approved Code of Practice "Classification and Labelling of Substances Dangerous for Supply".
A single application of the test material to the non-irrigated eye of one rabbit produced diffuse corneal opacity, irridial inflammation and severe conjunctival irritation. In addition sloughing of the conjunctival and
nictitating membrane, haemorrhage of the conjunctival membrane, blood stained discharge and a white appearance of the nictitating and conjunctival membranes were observed.
The test material produced a maximum total score of 79 - 85 and was regarded as at least a severe irritant (Class 7 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit).
The test material, DMAPSA, was regarded as at least a severe irritant to the rabbit eye (based on one rabbit only).
The test material, DMAPSA, was also considered as a severe irritant to the rabbit eye according to EEC Iabelling regulations.
It is reasonable to assume the symbol "Xi" and highest risk phrase R 41 "RISK 0F SERI0US DAMAGE T0 EYES" are therefore required.
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