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EC number: 224-137-2 | CAS number: 4210-32-6
- 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:
- january - march 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-tert-butylbenzonitrile
- EC Number:
- 224-137-2
- EC Name:
- 4-tert-butylbenzonitrile
- Cas Number:
- 4210-32-6
- Molecular formula:
- C11H13N
- IUPAC Name:
- 4-tert-butylbenzonitrile
- Details on test material:
- - Name of test material (as cited in study report): 4-tert-Butylbenzonitril
- Physical state: liquid
- Apperance: brown solution
- Analytical purity: > 94.2 %
- Impurities (identity and concentrations): 3-tert-Butylbenzonitiril
- Lot/batch No.: FHI/TVT 281098
- Storage condition of test material: refigerator (2-8 °C), 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: J. Schitkovits, A-2620 Natschbach
- Weight at study initiation: animal No. 71: 3.0 kg; animal No.72: 2.5 kg; animal No.73: 3.5 kg.
- Housing: individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 com x 59 cm x 35 cm.
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum. Random samples of the feed are analysed for contaminats by Altromin, D-32791 Lage.
- Water (e.g. ad libitum): tap water from an automatical watering system, ad libitum.
- Acclimation period: 11 days (animal No. 71) and 17 days (animal No. 72 and No. 73).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 20 °C
- Humidity (%): average of 59 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.
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 mL of 4-tert-Butylbenzonitrile
- Lot/batch no. (if required): FHI/TVT 281098
- Purity: > 94.2 % - Duration of treatment / exposure:
- 0.1 mL of the test substance was administered into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. After instillation, the eyes were held closed for about one second to prevent a loss of test substance.
The left eyes remained untreated and served as negative controls. - Observation period (in vivo):
- Eye examination: 1, 24, 48 and 72 h after the administration (p. a.) of the test substance.
- Number of animals or in vitro replicates:
- three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
CORNEA:
Opacity: degree of density (area most dense area is taken for reading).
0 No ulceration or opacity.
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre), details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS:
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).
CONJUNCTIVAE:
Redness: (refers to the most severe effect of palpebral and bulbar conjuctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels defintitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No sweling.
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed.
TOOL USED TO ASSESS SCORE: an otoscope lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 71, 72 and 73
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: # 71, 72 and 73
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal: # 71
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal: # 72 and 73
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal: # 71, 72 and 73
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 71
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 72 and 73
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 71, 72 and 73
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Cornea, Iris: Only scores of "0", i.e. normal, were noted in all animals at all examination terms.
Conjunctivea, redness and chemosis: 2/3 animals were affected 1 h p.a., with a score of "1". No changes were observed later on. - Other effects:
- No other effects were observed.
Any other information on results incl. tables
Table 1: Scores of the test eyes. Individual data and means.
Time after instillation (p.a.) |
Cornea |
Iris |
Conjunctivae |
|||||||||
Redness |
Chemosis |
|||||||||||
animal No. |
animal No. |
animal No. |
animal No. |
|||||||||
71 |
72 |
73 |
71 |
72 |
73 |
71 |
72 |
73 |
71 |
72 |
73 |
|
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean (24-72 h) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this test the test material 4-tert-Butylbenzonitrile is not considered to be an eye irritant.
- Executive summary:
In an acute eye irritation study according to OECD Guideline 405, 0.1 mL of 4 -tert-Butylbenzonitrile was instilled into the right eye of three female albino rabbits (New Zealand White strain). The eyes were not washed afterwards and the left eyes remained untreated and served as negative controls. The animals then were observed 1, 24, 48 and 72 hours after the treatment. Irritation was scored and recorded by a scoring system concerning cornea, iris and conjunctivae.
Under the testing conditions cornea and iris were not affected in all of the test animals. Some injected blood vessels and a very slight swelling were observed in 2/3 animals 1 h p.a. Nevertheless this effect was fully reversible and no lesions were observed at the other examination terms. Therefore no classification for eye irritation of 4 -tert-Butylbenzonitrile is derived from the results of this study.
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