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EC number: 217-703-5 | CAS number: 1934-75-4
- 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:
- 2001-01-18 to 2001-01-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium dicyanoamide
- EC Number:
- 217-703-5
- EC Name:
- Sodium dicyanoamide
- Cas Number:
- 1934-75-4
- Molecular formula:
- C2HN3.Na
- IUPAC Name:
- sodium dicyanamide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- The pH of a 10% w/w aqueous preparation of the test material was determined prior to
commencement of the study and found to be 9.7.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 2001-01-18 - 2001-01-21
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 (approx. 78 mg)
- Duration of treatment / exposure:
- single application, no washing
- Observation period (in vivo):
- 72 hours (study was terminated after 72 hours)
- Number of animals or in vitro replicates:
- single male animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
Interpretation of Results:
Using the numerical data obtained originally a modified version of the system described by Kay J H and Calandra J C, J. Soc. Cosmet. Chem., 1962 13 281-289 was used to classify the ocular irritancy potential of the test material.
Using the raw data, a re-interpretation according to recend standards was performed.
Judgment is based on cornea, iris, conjunctiva and chemosis calculated as mean scores for each animal following grading at 24, 48 and 72 hours after application of the test material, in consideration of reversibility.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Areas of diffuse corneal opacity were noted in the treated eye one and 24 hours after treatment with areas of translucent corneal opacity at the 48-hour observation and areas of opalescent comeal opacity at the 72-hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48 and 72-hour observation.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations with severe conjunctival irritation at the 72-hour observation. The nictitating membrane of this eye appeared pale throughout the study. Petechial haemorrhage scattered over the nictitating membrane was noted in the treated eye at the 24-hour observation.
Three areas of haemorrhage (approximately 2 mm x 2 mm in size:) on the nictitating membrane were noted in the treated eye at the 48 and 72-hour observation. - Other effects:
- - Lesions and clinical observations:
the animal was showing initial signs of moderate pain and was killed for humane reasons immediately after the 72-hour observation. No further animals were treated.
- Ophthalmoscopic findings:
Areas of diffuse corneal opacity were noted in the treated eye one and 24 hours after treatment with areas of translucent corneal opacity at the 48-hour observation and areas of opalescent comeal opacity at the 72-hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48 and 72-hour observation.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations with severe conjunctival irritation at the 72-hour observation. The nictitating membrane of this eye appeared pale throughout the study. Petechial haemorrhage scattered over the nictitating membrane was noted in the treated eye at the 24-hour observation.
Three areas of haemorrhage (approximately 2 mm x 2 mm in size:) on the nictitating membrane were noted in the treated eye at the 48 and 72-hour observation.
- Histopathological findings: no histopathology was performed
- Effects of rinsing or washing: no
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1 |
1 |
2 |
2 |
24 h |
1 |
1 |
2 |
2 |
48 h |
2 |
1 |
2 |
2 |
72 h |
3 |
1 |
3 |
3 |
Average 24h, 48h, 72h |
2 |
1 |
2.3 |
2.3 |
Area effected |
3 |
|
|
|
Reversibility*) |
n. |
n. |
n. |
n. |
Average time (unit) for reversion |
|
|
|
|
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (original table from study report)
Rabbit Number and Sex |
IPR= 3 |
|||
148 Male |
||||
Time After Treatment |
1 hour |
24 hours |
48 hours |
72 K hours |
CORNEA E= Degree of Opacity F = Area of Opacity |
1 3 |
1 3 |
2 3 |
3 3 |
Score (E x F) x 5 |
15 |
15 |
30 |
45 |
IRIS |
1 |
1 |
1 |
1 |
Score (0 x 5) |
5 |
5 |
5 |
5 |
CONJUNCTIVAE B = Chemosis C = Discharge |
2P 2 2 |
2P 2PT 3 |
2H 2P 3 |
3H 2P 3 |
Score (A + B + C) x 2 |
12 |
14 |
14 |
16 |
Total Score |
32 |
34 |
49 |
66 |
IPR = initial pain reaction
K = animal humanely killed immediately after observation
P = pale appearance of nictitating membrane
H = three areas of haemorrhage (approximately 2 mm x 2 mm) on the nictitating membrane
Pt = petechial haemorrhage scattered over nictitating membrane
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, Sodium dicyanoamide has irreversible effects on the eyes (Category 1).
- Executive summary:
In a primary eye irritation study according to OECD guideline 405, adopted 24 February 1987 and EU method B.5, 78 mg (approximately 0.1 mL) of Sodium dicyanoamide was instilled into the conjunctival sac of an eye of a male young adult New Zealand White rabbit. The eye was not rinsed after application. The animal was observed for 72 h. Irritation was scored by the method of Draize.
Instillation of the test substance into the eye resulted in severe effects on the eyes, necessitating intermediate sacrifice of the animal for ethical reasons approximately 72 hours after dosing.
Areas of diffuse corneal opacity were noted in the treated eye one and 24 hours after treatment with areas of translucent corneal opacity at the 48-hour observation and areas of opalescent corneal opacity at the 72-hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48 and 72-hour observation.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations with severe conjunctival irritation at the 72-hour observation. The nictitating membrane of this eye appeared pale throughout the study. Petechial haemorrhage scattered over the nictitating membrane was noted in the treated eye at the 24-hour observation.
Three areas of haemorrhage (approximately 2 mm x 2 mm in size:) on the nictitating membrane were noted in the treated eye at the 48 and 72-hour observation.
Due to the severity of effects in this animal, no further animals were treated.
In this study, Sodium dicyanoamide has irreversible effects on the eyes (Category 1).
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