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EC number: 213-709-7 | CAS number: 1003-52-7
- 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:
- other: according to OECD test guideline no. 405 (2002) and Commission Regulation (EC) No 440/2008, B.5.
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methyloxazole-5-carbonitrile
- EC Number:
- 213-709-7
- EC Name:
- 4-methyloxazole-5-carbonitrile
- Cas Number:
- 1003-52-7
- Molecular formula:
- C5H4N2O
- IUPAC Name:
- 4-methyl-1,3-oxazole-5-carbonitrile
- Details on test material:
- Name of test item (as cited in the report): CMO
Physical state: liquid
Purity: 99.9% (m/m)
Batch Number: 485
CAS Number: 1003-52-7
Expiry Date: 04-Dec-2010
Storage Conditions: In the refrigerator (range of 5 ± 3 °C, provided by Harlan Laboratories Ltd.), light and humidity protected, under inert gas (nitrogen).
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg / Germany
- Age at treatment start: males: 16 weeks, females 16 and 24 weeks
- Weight at streatment start: male: 3349 g, females 2912 g and 3347 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10 provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) available ad libitum. Results of analyses for contaminants are archived at Harlan Laboratories Ltd.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf ad libitum.
- Acclimation period: 26-Mar-2010 to 30-Mar-2010 (one female) and 26-Mar-2010 to 31-Mar-2010 (the male and the second female)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
IN-LIFE DATES: From: 31-Mar-2010 To: 08-Apr-2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/animal - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male
2 females - Details on study design:
- REMOVAL OF TEST SUBSTANCE
Washing (if done): no washing done
SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5.
Data were summarized in tabular form, showing for each individual animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean score for animal numbers 29, 30 and 31
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: individual mean score: 0 -0 -0
- Irritation parameter:
- iris score
- Basis:
- other: mean score for animal numbers 29, 30 and 31
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: individual mean score: 0 -0 -0
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean score for animal numbers 29, 30 and 31
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after instillation
- Remarks on result:
- other: individual mean scores: 2.00 - 1.67 - 1.33
- Irritation parameter:
- chemosis score
- Basis:
- other: mean score for animal numbers 29, 30 and 31
- Time point:
- 24/48/72 h
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days after instillation
- Remarks on result:
- other: individual mean scores: 2.00 - 2.67 -1.67
- Irritant / corrosive response data:
- The test item did not induce significant or irreversible damage to the rabbit eye.
- Other effects:
- When assessable, slight to moderate reddening of the sclerae was noted at the 48-hour reading in the male (No. 29) and in one female (No. 31). The sclerae was slightly reddened at the 72-hour reading in all animals. No scleral reddening was observed in any animal 7 days after test item instillation. Slight to marked discharge was noted in all animals from the 1- to 48-hour readings, and persisted as slight up to the 72-hour reading. Nostaining produced by the test item was observed in the treated eyes.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and
amending Regulation (EC) No 1907/2006), CMO corresponds to Category 2 irritating to eyes with respect to eye irritation in rabbits. - Executive summary:
The primary eye irritation potential of CMO was investigated according to OECD test guideline no. 405 (2002). The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed
approximately 1, 24, 48 and 72 hours, as well as 7 days after test item instillation. The eyes were not washed following instillation of the test item.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 2.00, 1.67 and 1.33 for reddening and 2.00, 2.67 and 1.67 for chemosis, respectively.
The instillation of CMO into the eye resulted in slight to marked, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, ocular discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or for the iris light reflex of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.
Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006), CMO corresponds to Category 2 irritating to eyes with respect to eye irritation in rabbits.
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