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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 15-FEB-2000 to 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 404 (Acute Dermal 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: stable at least 96h in the vehicle (water)
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Margate, Kent, England
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: less than 3.5 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day
- 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: from 15-FEB-2000 to 18-FEB-2000
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistened with water (Milli-U), immediately before application, to ensure close contact with the animal's skin.
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration (if solution): undiluted, moistened with water
VEHICLE
- Amount(s) applied: The test substance was moistened with 0.2 ml of the vehicle - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: the test substance was applied to the skin of one flank
- % coverage: data not available
- Type of wrap if used: a metalline patch of 2x3 cm was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: the skin was cleaned of residual test substance using water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72 h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Four hours exposure to 0.5 g of BHT resulted in very slight erythema in the treated skin-area of one rabbit, 1 hour after application only. No irritation was observed in the remaining two animals.
- Other effects:
- There was no evidence of a corrosive effect on the skin.
No staining of the treated skin by the test substance was observed.
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 |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
0 / 1 / 0 |
0 / 0 / 0 |
24 h |
0 / 0 / 0 |
0 / 0 / 0 |
48 h |
0 / 0 / 0 |
0 / 0 / 0 |
72 h |
0 / 0 / 0 |
0 / 0 / 0 |
Average 24h, 48h, 72h |
0 |
0 |
Reversibility |
yes |
- |
Average time for reversion |
24 hours |
- |
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 skin in rabbits
- Executive summary:
Three rabbits were exposed to 0.5 gram of BHT, applied onto clipped skin for 4 hours using a semi-occlusive dressing (OECD 404, not GLP). Observations were made 1, 24, 48 and 72 hours after exposure.
Exposure to the test substance resulted in very slight erythema in the treated skin-area of one rabbit, 1 hour after application only. No irritation was observed in the remaining two animals.
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (DSD and CLP regulation), BHT does not have to be classified and has no obligatory labelling requirement for skin irritation.
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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