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EC number: 212-298-1 | CAS number: 778-94-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 - 25 Feb 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 Jul 2015
- GLP compliance:
- yes
- Remarks:
- The test complied with the Principles of Good Laboratory Practices (GLP) of the Certification and Accreditation Administration of the People’s Republic of China (2013 revised edition).
Test material
- Reference substance name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
- EC Number:
- 212-298-1
- EC Name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
- Cas Number:
- 778-94-9
- Molecular formula:
- C8H3F3N2O2
- IUPAC Name:
- 2-nitro-4-(trifluoromethyl)benzonitrile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese long-eared white rabbit, general grade
- Details on test animals or test system and environmental conditions:
- - Source: Xinglong Experimental Animal Breeding Factory, Beijing, China
- Age at study initiation: 84 - 140 days
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 1.75 - 2.05 kg
- Housing: housed individually in hanging stainless steel rearing cages (L38 cm x W50 cm x H35 cm) affixed on rearing shelves (L200 cm x W65 cm x H170 cm)
- Diet: rabbit maintenance feed (Liaoning Changsheng Biotechnology Co., Ltd.,); ad libitum
- Water: every-day drinking water; ad libitum
- Acclimation period: 32 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.04 - 23.00
- Humidity (%): 40.28 - 63.40
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From 17 to 25 Feb 2019
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- but moistened with purified water
- Controls:
- other:
- Amount / concentration applied:
- Test material: 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: skin area (2.5 x 2.5 cm) on the right side of the mid-line below the shoulder blade
- % coverage: not reported
- Type of wrap if used: The test sample was spread evenly on a piece of gauze to which a small piece of non-irritating medical tape (approximately 2.5 cm x 2.5 cm) was adhered and moistened with a small amount of purified water.
REMOVAL OF TEST SUBSTANCE
- Washing: Clear water was used to wash the skin at the test area.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h and 4 - 6 days
SCORING SYSTEM: Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Edema (score 1) 1 h after removal of the dressing; reversible within 24 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- In the first animal, erythema was observed immediately after removal of the dressing, and after 1 h (score: 2) and 24 h (score: 2) and it persisted until the fifth day; on the sixth day there were no abnormalities. Oedema was observed 1 h after the dressing was removed (score: 1).
In the second animal, erythema was observed immediately after removal of the dressing, and after 1h (score: 1) and 24 h (score: 2) and it persisted until the fourth day (score: 1 after 72 h); on the fifth day there were no abnormalities. Oedema was observed 1 h after the dressing was removed (score: 1).
In the third animal, erythema was observed immediately after removal of the dressing, and after 1h (score: 1) and 24 h (score: 2) and it persisted until the fourth day (score: 1 after 48 h); on the fifth day there were no abnormalities. Oedema was observed 1 h after the dressing was removed (score: 1). In the three animals, mean dermal erythema/eschar and oedema scores at 24 h, 48 h, and 72 h after the dressings were removed were 1.3/0; 1.7/0; and 1.3/0, respectively. For details on study results, see section "any other information on results incl. tables", tables 1 - 2.
Any other information on results incl. tables
Table 1: Individual data for the skin irritation test in rabbits
Animal no. | Skin response | Individual score - observation timepoint (dressing removed) | ||||||
1 h | 24 h | 48 h | 72 h | 4 d | 5 d | 6 d | ||
1 | Erythema and eschar | 2 | 2 | 1 | 1 | 1 | 1 | 0 |
Oedema | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | Erythema and eschar | 1 | 2 | 2 | 1 | 1 | 0 | - |
Oedema | 1 | 0 | 0 | 0 | 0 | 0 | - | |
3 | Erythema and eschar | 1 | 2 | 1 | 1 | 1 | 0 | - |
Oedema | 1 | 0 | 0 | 0 | 0 | 0 | - |
Table 2: Mean scores of individual data in the skin irritation test in rabbits
Animal no. | Skin response | Mean total score of individual skin responses |
1 | Erythema/eschar | 1.3 |
Oedema | 0 | |
2 | Erythema/eschar | 1.7 |
Oedema | 0 | |
3 | Erythema/eschar | 1.3 |
Oedema | 0 |
Note: Means of the total points calculated at 24, 48 and 72 h after the dressings were removed.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the present test conditions, the test substance 2-nitro-4-(trifluoromethyl)benzonitrile was not irritating to the skin according to Draize criteria. In the three animals, mean dermal erythema / eschar and oedema scores at 24 h, 48 h, and 72 h after the dressings were removed were 1.3 / 0; 1.7 / 0; and 1.3 / 0. Based on the GHS classification criteria for dermal corrosion and irritation, this test material was not classified.
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