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EC number: 610-472-5 | CAS number: 49707-23-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-10-12 to 2010-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed study according to OECD Technical Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate attached to the report
Test material
- Reference substance name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- EC Number:
- 610-472-5
- Cas Number:
- 49707-23-5
- Molecular formula:
- C7 H13 N1 O3
- IUPAC Name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- Details on test material:
- - Sponsor's identification: NAAADA
- Container: plastic flask (n=1)
- Quantity: 51.80g (container and contents)
- Batch no: 700090909
- Production date: 09 September 2009
- CAS No of the main ingredients: 2226-96-2
- Date received: 16 September 2009
- Form: liquid
- Colour: yellow
- Storage: +4°C +/-4°C
- Expiry date: 09 January 2010
- Purity: >96%
- The item was used as supplied
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Supplied by: Elevage de Gérome (Quartier Labaste, F-40260 Linxe)
- Acclimitsation period: 5 days
- Weight at beginning of test: 2.99 - 3.37kg
- Age at beginning of test: 14 weeks
- Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Temperature: 17-23°C
- Relative humidity: 30-70%
- Air exchange rate was approximately 15 timer per hour
- Housing was illuminated by aritificial light in a 12hrs lighting / 12hrs darkness cycle
- Drinking water: tap-water from public distribution system, ad libitum
- Foodstuff: SDS-C15, ad libitum
- Microbial and chemical analyses of the water were carried out once every six months by the IPL, Santé, Environment Durables - Atlantique
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control
- Amount / concentration applied:
- 0.1mL of the test item was instilled into the conjuncitival sac of one eye
- Duration of treatment / exposure:
- 1d
- Observation period (in vivo):
- 1, 24, 48, 72 hrs following treatment
- Number of animals or in vitro replicates:
- Three (initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at day one, two additional animals were treated)
- Details on study design:
- - 0.1mL of the test item was instilled into the conjunctival sac of one eye
- The other eye remained untreated serving as control
- Intially, a single animal was treated
- After consideration of the ocular responses produced in the first treated animal at day 1, two additional animals were treated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- i.e. redness
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- i.e. redness
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- i.e. redness
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: See Table 1
Any other information on results incl. tables
Scoring according to OECD 405
Table 1: Individual and mean scores of conjunctivae, iris and cornea
Animal n° |
Time after |
CONJUNCTIVAE |
IRIS |
CORNEA |
|
CHEMOSIS (A) |
REDNESS (C) |
LESION (D) |
OPACITY (E) |
||
A9821 |
24 hours |
0 |
1 |
0 |
0 |
48 hours |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
TOTAL |
0 |
1 |
0 |
0 |
|
Mean |
0.0 |
0.3 |
0.0 |
0.0 |
|
A9824 |
24 hours |
0 |
1 |
0 |
1 |
48 hours |
0 |
1 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
TOTAL |
0 |
2 |
0 |
1 |
|
Mean |
0.0 |
0.7 |
0.0 |
0.3 |
|
A9830 |
24 hours |
0 |
1 |
0 |
0 |
48 hours |
0 |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
TOTAL |
0 |
1 |
0 |
0 |
|
Mean |
0.0 |
0.3 |
0.0 |
0.0 |
|
CLASSIFICATION |
According to the calculated means, the item is not be classified. |
||||
CLASSIFICATION |
According to the calculated means, the item iss not be classified. |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified. No signal word and hazard statement are required.
- Executive summary:
The test item NAAADA was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD Guideline 405 dated April 24th, 2002 and the test method B.5 of the council regulation no 440/2008.
The ocular conjunctivae reactions observed during the study have been slight and totally reversible in the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible between day 2 and day 3, associated with a slight chemosis, only noted 1 hour after the test item instillation.
A slight corneal opacity was noted in one animal on day 1 and was totally reversible on day 2.
In conclusion the results obtained under these experimental conditions enable to conclude that the test item NAAADA is not to be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the EEC Directive no 67/548, 2001/59 and 99/45. No symbol and warning label are required.
In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified. No signal word and hazard statement are required.
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