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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Test material form:
- other: solution
- Details on test material:
- - Name of test material (as cited in study report): 4-tert-Butylbenzonitril
- Physical state: brown solution
- Analytical purity: > 94.2 %
- Impurities: 3-tert-Butylbenzonitril
- Lot/batch No.: FHI/TVT 281098
- Storage condition of test material: refrigerator (2-8 °C), in the dark
- Other: stable under conditions of storage
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: J. Schitkovits, A-2620 Natschbach
- Weight at study initiation: animal No. 61: 3.3 kg; animal No. 62: 3.2 kg; animal No. 63: 2.7 kg.
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 76 cm 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
- Identification: Labelling with felt-tipped pen in a pinna.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 20 °C
- Humidity (%): average of 55 %
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL of the test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The treated areas and the surrounding untreated skin (control area) of the animals were examinated for erythema/eschar and oedema as well as for other local signs approximately 1, 24, 48 and 72 hours after patch removal. No examination were performed thereafter.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- coverage: about 2.5 cm x 2.5 cm
- Type of wrap if used: Samples of 0.5 mL of the test substance, were spread on cellulose patches (PurZellin-Tupfer, obtained by Fa. Hartmann, A-2355 Wiener Neudorf) were applied to the test sites. They were held in place by fixing them marginally with non irritating tapes ("Blenderm" surgical tape, hypoallergic, 3M, Medical Products Division, St. Paul, MN 551444, USA). The application sites were covered semi-occlusively by a dressing (Self adhesive non woven fabric, hypoallergenic, made by Beiersdorf AG, D-20245 Hamburg).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with wet Kleenex-tissues, if necessary.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema/Eschar formation:
0 No erythema.
1 Very slight erythema (barely perceptible).
2* Well-defined erythema.
3* Moderate to severe erythema.
4* Severe erythema (beet redness) or eschar formation (injuries in depht).
Oedema formation:
0 No oedema
1 Very slight oedema (barely perceptible).
2* Slight oedema (edges of area are well defined by definite raising).
3* Moderate oedema (raised approximately 1mm).
4* Severe oedema (raised more than 1 mm and extending beyond area of exposure).
* may indicate irritation (R38), according to EC-Guideline 93/21.
irreversible lesions require R34, according to EC-Guideline 93/21.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h after end of exposure
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h after end of exposure
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- The treated skin of all three animals was scored for erythema and oedema. The test substance caused no adverse effects to the skin, except very
slight erythema in one animal 60 minutes after removal of the bandage. This effect was fully reversible within 24 h. - Other effects:
- No general toxic effects were noted.
Any other information on results incl. tables
Table 1: Scores for the application sites. Individual data and means.
Time after the end of exposure |
Erythema / Eschar |
Oedema |
||||
animal Nos |
animal Nos. |
|||||
61 |
62 |
63 |
61 |
62 |
63 |
|
1 h |
1 |
1 |
1 |
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 |
Mean (24-72 h) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Scoring system see section "details on study design".
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The treated skin of all three animals was scored for erythema and oedema. The test substance caused no adverse effects to the skin, except very
slight erythema in one animal 60 minutes after removal of the bandage. This effect was fully reversible within 24 h. This indicates that the test substance 4-tert-Butylbenzonitrile did not cause any skin irritation or corrosion in this study. - Executive summary:
The dermal irritation/corrosion potential of 4-tert-Butylbenzonitrile was examined in three female New Zealand White rabbits. Parts of there intact and shaved skin were exposed for 4 hours. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local signs approximately 1, 24, 48, 72 hours after patch removal. Dermal irritation was described and recorded using a scoring system for erythema and oedema. The test substance caused no adverse effects to the skin, except very slight erythema in one animal 60 minutes after removal of the bandage. This effect was fully reversible within 24 h. This indicates that the test substance 4-tert-Butylbenzonitril did not cause any skin irritation or corrosion in this study.
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