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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Feb - 15 Mar 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 Jun 2021
- 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).
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The guinea pig is the animal of choice according to the Guidelines of Chemical Testing (HJ/T 153-2004) and Chemical Test Methods ¨C Health Effects Volume (second edition) and this test is the method of choice in China.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Standard grade
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Liaoning Changsheng Biotechnology Co., Ltd., Liaoning, China
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 248.33 - 303.43 g
- Housing: 5 - 6 guinea pigs were reared in one plastic box (L 92 cm x W 62 cm x H 25 cm)
- Diet: guinea pig maintenance feed (Liaoning Changsheng Biotechnology Co., Ltd., Liaoning, China); ad libitum
- Water: every-day drinking water; ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: no skin damage noticed
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.05 - 23.00
- Humidity (%): 40.15 - 69.96
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: 03 Feb - 15 Mar 2019
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol 80%
- Concentration / amount:
- 0.2 g test sample and 0.2 mL vehicle
- Day(s)/duration:
- days 0, 7 and 14 (6 h exposure)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.2 mL 50 % test sample solution
- Day(s)/duration:
- day 28 (6 h exposure)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 (in test group)
10 (controls) - Details on study design:
- RANGE FINDING TESTS:
4 doses (unchanged test sample and 50%, 25% and 12.5% test sample solutions (W/V) in 80% ethanol) were prepared and tested in 2 animals. The exposure was 6 h (epicutaneous, occlusive), and skin response was observed approximately 1 and 24 h after removal of the dressing. Obvious erythema (H2) was noted in 1 animal exposed to the undiluted test sample. No visible change was observed for the other concentrations tested. Thus, 0.2 g (± 1%) test sample moistened with 0.2 mL vehicle was selected for the induction exposure, and 0.2 mL 50% test sample solution was selected for the challenge exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance moistened in 0.2 mL vehicle (80% ethanol)
- Control group: vehicle only
- Site: left side of the back
- Frequency of applications: every 7 days
- Duration: days 0 - 14
- Concentrations: undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: test sample solution in acetone
- Control group: test sample solution in acetone
- Site: right side of the back
- Concentrations: 50%
- Evaluation (hr after challenge): approximately 24 h and 48 h after removal of the dressing - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- induction: 0.2 mL 50% 2-mercaptobenzothiazole solution (vehicle: 80% ethanol) challenge: 0.2 mL 2.5% 2-mercaptobenzothiazole solution (vehicle: acetone)
Results and discussion
- Positive control results:
- 0.2 mL 50% 2-mercaptobenzothiazole solution (vehicle: 80% ethanol) was used for the induction exposure. 0.2 mL 2.5% 2-mercaptobenzothiazole solution (vehicle: acetone) was used for the challenge exposure. The skin sensitisation rate was 30%, confirming that the methodology used in this test and the sensitivity of the animals were valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: reading validity test
- Group:
- positive control
- Dose level:
- Induction: 50% Challenge: 2.5%
- Remarks on result:
- other: positive indication of skin sensitisation (rate: 30%)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0% Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: undiluted (100%) challenge: 50%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema observed in 3 animals; confluent erythema observed in 6 animals
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0% Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: undiluted (100%) challenge: 50%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema observed in 5 animals
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
SKIN RESPONSE
Induction: There were no visible changes in the skin at the exposure
site for the animals in the control group. In the test group, all
animals exhibited erythema, to varying degrees, at the skin of the
exposure site. 9 animals exhibited hardening and breaking of the skin at
the exposure site (see table 1).
Challenge: There were no visible changes at the skin of the exposure
site in the animals in the control group. In the test group, 6 animals
exhibited confluent erythema (grade 2) at the skin of the exposure site
and 3 animals exhibited discrete erythema (grade 1) at the skin of the
exposure site (see table 2; 24 h observation time point).
SKIN SENSITISATION RATE
Method for calculating skin sensitisation rate for all groups: The number of animals in this group exhibiting sensitivity response was divided by the total number of animals in this group, to arrive at the skin sensitisation rate for this group of animals.
Result: The skin sensitisation rate was 45%.
Table 1: Test Group Induction Exposure Skin Response
Animal no. |
Day 0 |
Day 7 |
Day 14 |
||||||
1 h after dressing was removed |
24 h after dressing was removed |
48 h after dressing was removed |
1 h after dressing was removed |
24 h after dressing was removed |
48 h after dressing was removed |
1 h after dressing was removed |
24 h after dressing was removed |
48 h after dressing was removed |
|
1 |
H1 |
H1 |
N |
N |
N |
N |
H1 |
N |
N |
2 |
H2 |
H1 |
N |
H2 |
H1 |
N |
H2 |
H1 |
A |
3 |
H1 |
N |
N |
H1 |
N |
N |
H1 |
N |
A |
4 |
H2 |
H1 |
N |
H2 |
N |
N |
H2 |
H2 |
A |
5 |
H2 |
H1 |
N |
H1 |
H1 |
N |
H1 |
N |
N |
6 |
H1 |
N |
N |
H1 |
N |
N |
H1 |
N |
A |
7 |
H2 |
H1 |
N |
H1 |
N |
N |
H1 |
N |
N |
8 |
H2 |
H1 |
N |
H2 |
N |
N |
H2 |
N |
N |
9 |
H1 |
N |
N |
H1 |
N |
N |
N |
N |
N |
10 |
H2 |
H1 |
N |
N |
N |
N |
H2 |
N |
N |
11 |
H1 |
N |
N |
H1 |
N |
N |
H1 |
N |
N |
12 |
H2 |
H1 |
N |
H2 |
N |
N |
H2 |
N |
N |
13 |
H1 |
N |
N |
H1 |
N |
N |
H1 |
N |
A |
14 |
H1 |
N |
N |
H2 |
N |
N |
H1 |
H1 |
N |
15 |
H1 |
N |
N |
N |
N |
N |
H1 |
N |
N |
16 |
H1 |
N |
N |
H1 |
N |
N |
N |
N |
A |
17 |
H1 |
N |
N |
H1 |
H1 |
N |
H1 |
N |
N |
18 |
H2 |
H1 |
N |
H1 |
N |
N |
H1 |
H1 |
A |
19 |
H1 |
N |
N |
N |
N |
N |
H1 |
N |
A |
20 |
H1 |
N |
N |
H1 |
N |
N |
H2 |
H1 |
A |
N: no visible changes H1: mild erythema H2: obvious erythema A: skin hardening and breaking
Table 2: Test Group Challenge Exposure (Day 28) Skin Response and Score
Animal no. |
24 h after dressing was removed |
48 h after dressing was removed |
||
Skin response |
Total score |
Skin response |
Total score |
|
1 |
N |
0 |
N |
0 |
2 |
N |
0 |
N |
0 |
3 |
B |
2 |
A |
1 |
4 |
B |
2 |
N |
0 |
5 |
A |
1 |
N |
0 |
6 |
N |
0 |
N |
0 |
7 |
B |
2 |
A |
1 |
8 |
N |
0 |
N |
0 |
9 |
N |
0 |
N |
0 |
10 |
N |
0 |
N |
0 |
11 |
N |
0 |
N |
0 |
12 |
N |
0 |
N |
0 |
13 |
B |
2 |
A |
1 |
14 |
B |
2 |
A |
1 |
15 |
A |
1 |
N |
0 |
16 |
N |
0 |
N |
0 |
17 |
A |
1 |
N |
0 |
18 |
N |
0 |
N |
0 |
19 |
N |
0 |
N |
0 |
20 |
B |
2 |
A |
1 |
N: no visible changes A: discrete erythema B: confluent erythema
BODY WEIGHT
All animals gained body weight during testing period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens. 1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- The skin sensitisation rate for the animals in the control group was 0%, and for the animals in the test group 45%. Under the conditions of this test and based on the test results, 2-nitro-4-(trifluoromethyl)benzonitrile is classified as Skin Sens. 1B (H317) according to Regulation (EC) No 1272/2008.
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