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EC number: 219-340-8 | CAS number: 2420-17-9
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- end on 19-APR-2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study performed according to OECD guideline, not GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-(phenylmethyl)imidazolidine-2,4-dione
- EC Number:
- 222-563-3
- EC Name:
- 5-(phenylmethyl)imidazolidine-2,4-dione
- Cas Number:
- 3530-82-3
- IUPAC Name:
- 5-benzylimidazolidine-2,4-dione
- Details on test material:
- - Name of test material (as cited in study report): BHT
- Molecular formula (if other than submission substance): C10H10N2O2
- Molecular weight (if other than submission substance): 190.20
- Smiles notation (if other than submission substance): N1C(N[C@@H](C1=O)Cc1ccccc1)=O
- InChl (if other than submission substance): InChI=1/C10H10N2O2/c13-9-8(11-10(14)12-9)6-7-4-2-1-3-5-7/h1-5,8H,6H2,(H2,11,12,13,14)
- Structural formula attached as image file (if other than submission substance): see Fig. attached
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature in the dark
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 UK, Margate, Kent, England
- Age at study initiation: 7 to 9 weeks old
- Weight at study initiation: 1276g, 1524g and 1568g
- Housing: Individually housed in labelled cages with perforated floors
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week.
- Water: free access to tap-water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 30-70%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day
IN-LIFE DATES: data not available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: aach animal was treated by instillation of 53.8 +/- 0.9 mg of the test substance (a volume of approximately 0.1 ml)
- Concentration (if solution): undiluted - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to OECD guideline
TOOL USED TO ASSESS SCORE: Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean (24,48,72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean (24, 48, 72h)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean (24, 48, 72h)
- Score:
- ca. 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean (24, 48, 72h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritant / corrosive response data:
- Instillation of approximately 54 mg of the test substance (a volume of approximately 0.1 ml) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. lridial irritation (grade 1) was observed in all animals on day 1 and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 24 hours in one animal, within 48 hours in another animal and within 72 hours in the last animal. No corneal opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
- Other effects:
- - Corrosion: there was no evidence of ocular corrosion.
- Colouration: remnants of the test substance were present in the eyes of all animals on day 1.
- Toxicity / Mortality: no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
1/1/1 |
2/1/1 |
0/2/1 |
24 h |
0/0/0 |
0/0/0 |
1/0/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
1/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0.7/0/0.3 |
0/0/0 |
Reversibility |
- |
yes |
yes |
yes |
Average time for reversion |
- |
After 24h |
After 72h |
After 24h |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- BHT is not irritating to the eyes in rabbits
- Executive summary:
In a primary eye irritation study (OECD guideline 405, not GLP), 54 mg of undiluted BHT (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Irritation was scored by the method of OECD guideline.
Iridial irritation (grade 1) was observed in all animals on day 1 and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 24 hours in one animal, within 48 hours in another animal and within 72 hours in the last animal. No corneal opacity was observed, and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals.
Remnants of the test substance were present in the eyes of all animals on day 1.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (DSD and CLP), BHT does not have to be classified and has no obligatory labelling requirement for eye irritation.
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