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EC number: 452-330-3 | 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
- Study period:
- 04 August 2003 to 17 August 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to GLP and in line with the standardised guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400 with no deviations thought to impact the reliability of the presented results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 452-330-3
- EC Name:
- -
- Cas Number:
- 314020-40-1
- Molecular formula:
- C14H20N2O2
- IUPAC Name:
- 2-(2,6-diethyl-4-methyl-phenyl)propanediamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: Powder, yellowish
- Storage condition of test material: In the dark at ambient temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 2656-3148 g
- Housing: The animals were housed individually
- Diet: ad libitum
- Water: ad libitum, mains water
- Acclimation period: At least 5 days prior to study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes minimum
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark
IN-LIFE DATES: From: 05 August 2003 To: 17 August 2003
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- - Dose administration: Approximately 100 mg of the test substance was applied into the conjunctival sac of the left eye of one rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for 1-2 seconds after which the animal was released. The other eye was untreated (control eye).
- Observation period (in vivo):
- Animals were observed up to 7 days post administration
- Number of animals or in vitro replicates:
- One animal initially, followed by a further two animals once the irritation potential was fully assessed in the first animal.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Irrigation was not performed
SCORING SYSTEM:
The reactions observed were scored in accordance with the criteria of Draize (1959) and assessed using a modified form of the Kay and Calandra system (1962)
TOOL USED TO ASSESS SCORE: To aid scoring, animals were placed in an artificial daylight chamber for each assessment of irritation. In addition, as an aid in the assessment of corneal damage, fluorescing staining was used at all readings from 1 day after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Time point until effect occurred is given
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: Time point until effect occurred is given
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: Time point until effect occurred is given
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: Time point until effect occurred is given
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: Time point until effect occurred is given
- Irritant / corrosive response data:
- The maximum score for each parameter was calculated using the Draize (1959) scoring system as presented in table 1 under the field "Any other information on materials and methods incl. tables".
Application into the eye caused practically no initial pain (Class 1 on a 0-5 scale). There were no corneal iridial effects. Conjunctival effects consisted of slight redness in all animals up to 4 days and slight chemosis in two animals approximately 1 hour after application. In addition, one animal had slight erythema of the eyelids approximately 1 hour after application. All signs of irritation had completely resolved within 7 days of application.
Under the conditions of the study, the test material was considered to be mildly irritating to the unrinsed eye according to a modified form of the Kay and Calandra system. - Other effects:
- There were no signs of ill-health in any animal during the study.
Any other information on results incl. tables
Table 3: Mean scores
Observation |
1 h (3)* |
1 d (3) |
2 d (3) |
3 d (3) |
4 d (1) |
7 d (1) |
Cornea (Max 80) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Iris (Max 10) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Conjunctiva (Max 20) |
3.3 |
0.7 |
0.7 |
0.7 |
2.0 |
0.0 |
Mean Total Score: (Max 110) |
3.3 |
0.7 |
0.7 |
0.7 |
2.0 |
0.0 |
*Numbers in parentheses indicate number of animals included in observation
Table 4: Individual scores
Cornea | Iris | Conjunctiva | ||||||||||
Animal number | Sex | Elapsed time | Opacity | Area | Score | Score | Redness | Chemosis | Discharge | Score | Total score | |
77 | M | 1 h | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 |
1 d | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
2 d | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
3 d | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
4 d | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | ||
7 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
105 | F | 1.3 h | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 |
1 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
106 F | F | 1.2 h | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 4 | 4 |
1 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The eye irritation of the test material was determined in accordance with the standardised guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400. Approximately 100 mg of test material was applied into one one of each of three rabbits and were assessed for up to 7 days to determine the grade of ocular reaction. There were no iridial effects. Conjunctival effects consisted of slight redness in all animals for up to 4 days and slight chemosis in two animals approximately 1 hour after application. In addition, one animal had slight erythema of the eyelids approximately 1 hour after application. All signs of irritation had completely resolved within 7 days of application.
Under the conditions of the study, the test material was considered to be mildly irritating to the unrinsed eye according to modified form of the Kay and Calandra system. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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