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EC number: 210-259-3 | CAS number: 611-20-1
- 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:
- 29th September 2011 - 14th May 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to a national guideline method, essentially equivalent to a OECD TG 405 (1987 edition). Although not conducted under GLP (OECD), the study was conducted under a similar national quality assurance system. Adequately documented study, although not all raw data was reported, this did not effect the conclusions, especially considering the detailed description of the observed effects and persistence. Purity data available separately for test batch.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987 edition
- Deviations:
- yes
- Remarks:
- Only total scores for cornea and conjunctivae reported.
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for the Testing of Chemicals: Test No. 405: Acute eye irritation/corrosion test (MEP, People's Republic of China, 2004)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The methodology followed was equivalent to the 1987 version of OECD TG 405, which deviates from the latest 2002 version, particularly in the number of animals used. The inital test with 4 animals ("unwashed test") was followed by two further tests of 3 animals each, with eye irrigation at 4 seconds after instillation, and irrigation at 30 seconds, respectively. Evaluation was according to Kay&Calandra, although not explicitly referenced.
- GLP compliance:
- no
- Remarks:
- The study was conducted in compliance with a national quality assurance system, with similar objectives to GLP (OECD).
Test material
- Reference substance name:
- Salicylonitrile
- EC Number:
- 210-259-3
- EC Name:
- Salicylonitrile
- Cas Number:
- 611-20-1
- Molecular formula:
- C7H5NO
- IUPAC Name:
- 2-hydroxybenzonitrile
- Details on test material:
- - Name of test material (as cited in study report): 2-cyanophenol
- Substance type: powder
- Physical state: solid
- Purity test date: not reported
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: not reported
- Weight at study initiation: ca. 2.3kg
- Housing: Suspended, wire bottom, stainless steel, 1 animal per cage
- Diet: ad libitum (Statement that contaminents in feed and water effecting study outcome not expected)
- Water: ad libitum (Municipal water supply, analyzed by City Water Quality Monitoring Center of Zhejiang Province)
- Acclimation period: 5 days
- Sex: male and female, nulliparous & non-pregnant
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Ground to a fine powder and sieved through 0.154mm mesh
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1g - Duration of treatment / exposure:
- - Initial Test: 24 hours
- Second Test: 4 seconds
- Third Test: 30 seconds - Observation period (in vivo):
- 21 days with observations at 1h, 24h, 48h, 72h, 96h, 7 days, 14 days, 21 days.
- Number of animals or in vitro replicates:
- - Initial Test: 4
- Second Test: 3
- Third Test: 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: gently rinsed for 30s with 0.9% saline water
- Initial Test, time after start of exposure: 24h
- Second Test, time after start of exposure: 4s and 24h
- Third Test, time after start of exposure: 30s and 24h
SCORING SYSTEM:
As described in The Guidelines for the Testing of Chemicals: Test No. 405: Acute Eye Irritation/Corrosion Test (Ministry of Environmental Protection of the People's Republic of China.
TOOL USED TO ASSESS SCORE:
Corneas of all treated eyes were examined with sodium fluorescein ophthalmic solution at 24h. Any corneas exhibiting staining were followed at subsequent observation points with fluorescein solution until staining no longer occurred.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- 40
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 20
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 20
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 15
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 40
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 40
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 20
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 5
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 5
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 12
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 12
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 18
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 16
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 16
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 18
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- overall irritation score
- Remarks:
- Sum of cornea, iris and conjunctivae scores
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 41
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: No eye irrigation; see tables for full data
- Irritation parameter:
- overall irritation score
- Remarks:
- Sum of cornea, iris and conjunctivae scores
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 10
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: No eye irrigation; see tables for full data
- Irritation parameter:
- overall irritation score
- Remarks:
- Sum of cornea, iris and conjunctivae scores
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 28
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: No eye irrigation; see tables for full data
- Irritation parameter:
- overall irritation score
- Remarks:
- Sum of cornea, iris and conjunctivae scores
- Basis:
- animal #4
- Time point:
- 21 d
- Score:
- 22
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: No eye irrigation; see tables for full data
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not reported
- Irritant / corrosive response data:
- Observation results of eye reaction (unwashed test) after the application were shown as diffuse beefy red, swelling with lids more than half closed, discharge with moistening of the lids and hairs, and a considerable area around the eye in the conjunctivae. The main symptoms affecting the cornea include easily discernible translucent area, details of iris slightly obscured, the damage area covered greater than three quarters, or up to whole area. There was observed fluorescein staining with scales in corneas and congestion in iris. Area of angiogenesis was greater than one quarter, but less than half in cornea surface (moderately. The corneas displayed slight dulling of normal luster. The highest average of total score until 4d after instillation was 55.50. Duration of irritation reaction was the average of total score on day 7>40.
Observation results of eye reaction (washed test, 4s after instillation) were shown as diffuse beefy red, swelling with lids about half closed, discharge with moistening of the lids and hairs, and a considerable area around the eye in the conjunctivae. The main symptoms affecting the cornea include easily discernible translucent area, details of iris slightly obscured, the damage area covered greater than three quarters. There was observed fluoresdcein staining within the corneal opacity area and congestion in iris. Area of angiogenesis was greater than ten percent, but less than one quarter in cornea surface (mildly). The corneas displayed slight dulling of normal luster. The highest average of total score until 4d after instillation was 40.67. Duration of irritation reaction was the average of total score on day 7>20.
Observation results of eye reaction (washed test, 30s after instillation) were shown as diffuse beefy red, swelling with lids about half closed, discharge with moistening of the lids and hairs, and a considerable area around the eye in the conjunctivae. The main symptoms affecting the cornea include easily discernible translucent area, details of iris slightly obscured, the damage area covered greater than three quarters. There was observed fluorescein staining within the corneal opacity area and congestion in iris. Area of angiogenesis was greater than ten percent, but less than one quarter in cornea surface (mildly) . The corneas were slight dulling of normal luster. The highest average of total score until 4d after instillation was 53.00. Duration of irritation reaction was the average of total score on day 7<40, more than half animals>30, but no animals>60. - Other effects:
- None reported.
Any other information on results incl. tables
Table 1: Initial and final body weights for initial test (“unwashed”).
|
Animal 1 |
Animal 2 |
Animal 3 |
Animal 4 |
Start weight |
2.40 |
2.42 |
2.30 |
2.13 |
Finish weight |
2.46 |
2.50 |
2.42 |
2.21 |
Table 2: Ocular reactions for the initial test (“unwashed”).
Time after treatment |
Animal number |
Score |
Total score |
Average of total score |
||
Cornea |
Iris |
Conjunctivae |
||||
1h |
1 |
- |
0 |
6 |
6 |
6.5 |
2 |
- |
0 |
6 |
6 |
||
3 |
- |
0 |
6 |
6 |
||
4 |
- |
0 |
8 |
8 |
||
24h |
1 |
40 |
5 |
12 |
57 |
55.50 |
2 |
20 |
5 |
16 |
41 |
||
3 |
40 |
5 |
16 |
61 |
||
4 |
40 |
5 |
18 |
63 |
||
48h |
1 |
40 |
5 |
12 |
57 |
55.50 |
2 |
20 |
5 |
16 |
41 |
||
3 |
40 |
5 |
16 |
61 |
||
4 |
40 |
5 |
18 |
63 |
||
72h |
1 |
40 |
5 |
18 |
63 |
50.75 |
2 |
15 |
5 |
16 |
36 |
||
3 |
20 |
5 |
16 |
41 |
||
4 |
40 |
5 |
18 |
63 |
||
96h |
1 |
40 |
5 |
18 |
63 |
50.75 |
2 |
15 |
5 |
16 |
36 |
||
3 |
20 |
5 |
16 |
41 |
||
4 |
40 |
5 |
18 |
63 |
||
7 day |
1 |
40 |
5 |
18 |
63 |
44.75 |
2 |
15 |
5 |
16 |
36 |
||
3 |
20 |
5 |
14 |
39 |
||
4 |
20 |
5 |
16 |
41 |
||
14 day |
1 |
20 |
5 |
18 |
43 |
30.5 |
2 |
5 |
5 |
12 |
22 |
||
3 |
10 |
5 |
18 |
33 |
||
4 |
5 |
5 |
14 |
24 |
||
21 day |
1 |
20 |
5 |
16 |
41 |
25.25 |
2 |
0 |
0 |
10 |
10 |
||
3 |
5 |
5 |
18 |
28 |
||
4 |
5 |
5 |
12 |
22 |
The highest average total score up to 4 days after instillation: 55.50
Duration of irritation reaction: the average total score on day 7: >40
Evaluation: “very severely irritating” (rating 7)
Table 3: Ocular reactions at 21 days for the post-instillation irrigation satellite groups (second and third tests), with eye irrigation at 4s and 30s after instillation respectively.
Time after treatment |
Animal number |
Score |
Total score |
Average of total score |
||
Cornea |
Iris |
Conjunctivae |
||||
Second test (4s), 21 days |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
Evaluation |
The highest average total score up to 4 days after instillation: 40.67 Duration of irritation reaction: the average total score on day 7: >20 Evaluation: “severely irritating” (rating 6) |
|||||
Third test (30s), 21 days |
1 |
5 |
5 |
10 |
20 |
|
2 |
5 |
5 |
8 |
18 |
||
3 |
0 |
0 |
8 |
8 |
||
Evaluation |
The highest average total score up to 4 days after instillation: 53.00 Duration of irritation reaction: the average total score on day 7: <40, more than half animals >30, but no animals >60 Evaluation: “severely irritating” (rating 6) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The current OECD and EU guidelines deviate from the 1987 OECD guideline primarily with respect to numbers of animals and use of satellite groups. Despite only the total scores for cornea and conjunctivae being reported, the descriptive summary allows reconstruction of the maximum scores for corneal opacity (2), the area involved (4), and iris (1). A combination of the descriptive summary of the observations and the effects being observed to 21 days, means the report is adequate for classification and risk assessment purposes.
- Executive summary:
In a primary eye irritation study, 0.1g of 2-cyanophenol was instilled into the conjunctival sac of the right eye of male or female New Zealand white rabbits (4) for 24 hours. Treated eyes were gently washed with 0.9% saline solution after 24 hours. Animals then were observed for 21 days. Irritation was scored by the method of Draize. Ocular reactions after instillation were diffuse beefy red conjunctivae, swelling with lids more than half closed, discharge with moistening of the lids and hairs, and a considerable area around the eye. The cornea showed discernible translucent areas, details of iris slightly obscured, and the damaged area covered greater than three quarters, or up to whole area. There was congestion evident in the iris. Effects were persistent to 21 days. In this study, 2 -cyanophenol was found to be very severely irritating (rating 7) according to Guidelines for the testing of chemicals: Test No. 405: Acute eye irritation/corrosion test (Ministry of Environmental Protection of the People's Republic of China, 2004).
Two satellite groups, each of 3 animals, were instilled with 0.1g of 2-cyanophenol into the conjunctival sac of the right eye for 24 hours. Treated eyes were gently washed with 0.9% saline solution after 4 and 30 seconds respectively. Animals then were observed for 21 days. Irritation was scored by the method of Draize.
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