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EC number: 249-277-1 | CAS number: 28874-51-3
- 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:
- 26 April 2012 to 29 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (the eyes of the test animals were washed 1 hour after administration of the test material).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- sodium (2S)-5-oxopyrrolidine-2-carboxylate
- Cas Number:
- 28874-51-3
- Molecular formula:
- C5H6NO3. Na
- IUPAC Name:
- sodium (2S)-5-oxopyrrolidine-2-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: White to pale yellow powder.
- Storage condition of test material: Controlled room temperature (15-25 °C, below 70 RH %), protected from humidity.
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: Approximately 14 weeks old (adults).
- Weight at study initiation: Males ranged from 3251 to 3518 g.
- Housing: Individually in open wire cages.
- Diet: rabbit diet, ad libitum.
- Water: Municipal tap water, ad libitum.
- Acclimation period: 29 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15 to 20 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day between 06:00 and 18:00 hours.
IN-LIFE DATES: From: 26 April To: 29 April
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g. - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- DOSING
- Procedure: An initial test was performed using one animal to assess the initial pain reaction. After consideration of the ocular responses produced in the first animal, one hour after the treatment of the first animal, two additional animals were treated.
- Administration: The test material was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item.
SCORING SYSTEM
- Initial pain reaction: Immediately after the administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1.
- Ocular response: The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. The eye irritation scores were evaluated according to the scoring system by Draize (1977) shown in Table 2.
OTHER OBSERVATIONS:
- Clinical: Any clinical signs of toxicity or signs of ill-health during the study were recorded.
- Bodyweight: Individual body weight was recorded at the beginning and end of the experiment.
- Necropsy: Performed at termination of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Initial Pain Reaction (IPR): A score of 2 was observed in all animals.
- One hour after the application: Conjunctival redness (score 1 or 2) and discharge (score 1 or 2) were seen in all rabbits. One animal showed conjuctival chemosis (score 1).
- At 24 hours after treatment: Conjunctival redness (score 1) was seen in one rabbit.
- At 48 and 72 hours after treatment: No signs of eye irritation were observed.
- Reversibility: As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation. - Other effects:
- - Mortality: None observed during the study.
- Bodyweight: The body weight and body weight change were considered to be normal with no indication of a treatment related effect. Bodyweights ranged from 3420 to 3553 g at termination representing a weight gain of between 35 and 169 g.
- Clinical: There were no clinical signs observed that could be related to treatment.
Any other information on results incl. tables
Table 3: Individual Scores for Ocular Irritation at 1 Hour
Animal No. |
Score of Irritation |
IPR |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
1 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
- |
2 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
2 |
3 |
2 |
0 |
2 |
0 |
0 |
0 |
0 |
- |
2 |
Table 4: Individual Scores for Ocular Irritation at 24 Hour
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Table 5: Individual Scores for Ocular Irritation at 48 Hour
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Table 6: Individual Scores for Ocular Irritation at 72 Hour
Animal No. |
Score of Irritation |
|||||||
Conjunctivae |
Opacity of Cornea |
Iris |
Control Eye |
Other Signs |
||||
R |
CH |
D |
OD |
OE |
R |
|||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
R = redness, CH = chemosis; D = discharge; OD = opacity degree of density; OE = extent of opaque area; IPR = initial pain reaction.
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 was determined to be non-irritating. Slight conjunctival redness and discharge were observed in all three animals one hour after administration, and one animal also showed slight chemosis. All ocular reactions were fully reversed by 48 hours post exposure. These reactions were slight and below the limit of classification.
- Executive summary:
The potential for the test material to cause eye irritation was assessed in an in vivo irritation study in rabbits. The study was performed under GLP conditions in line with standardised guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400. The test material was administered to three male New Zealand white rabbits, in a single 1 hour application. Rabbits were assessed over 72 hours for signs of eye irritation, clinical sign of toxicity, mortality and bodyweight gain. Application of the test material to the rabbit’s eye caused slight conjunctival redness and discharge in all three animals, one hour after administration. One animal also showed slight chemosis at one hour. These slight signs of irritation were fully reversed within 48 hours, and subsequently the study was terminated after 72 hours. Under the conditions of the study, the test material was determined to be non-irritating.
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