Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-02-09 to 2001-03-18
- 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 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. The study has been conducted before the new annex of the REACH Regulation entered into force. Moreover, clear indication for strong skin sensitisation was observed in this study, thus allowing potency estimation. For this reason and for reasons of animal welfare no additional LLNA was conducted.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Microbiological status of animals: unknown
- Age at study initiation: approximately eight to twelve weeks
- Weight at study initiation: 308 to 378 g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 09 Feb 2001 To: 18 March 2001
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 5 % of the test item, in distilled water
Dermal induction: 25 % of the test item, in distilled water - Day(s)/duration:
- intradermal: day 0; dermal: day 7 (for 48 h)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% w/w in distilled water
- Day(s)/duration:
- day 21 (for 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10 % w/w in distilled water
- Day(s)/duration:
- day 21 (for 24 hours)
- Adequacy of challenge:
- other: to ensure that the maximum non-irritant concentration was used
- No. of animals per dose:
- Number of animals in the test group: 10
Number of animals in the negative control group: 5
Number of animals in the dose range finding study: 6 - Details on study design:
- RANGE FINDING TESTS:
Selection of concentration for intradermal induction
Four animals were treated intradermally (0.1 mL/injection site) with a concentration of 1 %, 5%, 10% and 25% w/w of the test item in distilled water. The degree of erythema at the injection sites was assessed approximately 24, 48, 72 hours and 7 days after injection.
Selection of concentration for topical induction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant ten days earlier) were treated with four preparations of the test material (75%, 50%, 25% and 10% w/w in distilled water). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 48 hours. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermal irritation was selected for the topical induction stage of the main study.
Selection of concentration for topical challenge
Four preparations of the test material (50%, 25%, 10% and 5% w/w in distilled water) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Application (day 0)
- No. of exposures: 3 pairs of intradermal injections of 0.1 mL
- Test groups:
a) - a 1:1 mixture (v/v) FCA/ distilled water
b) - a 5% formulation of the test material in distilled water
c) - a 5% formulation of the test material in a 1:1 mixture (v/v) FCA/ distilled water
- - Control groups:
a) - a 1:1 mixture (v/v) FCA/ distilled water
b) - distilled water
c) – distilled water in a 1:1 mixture (v/v) FCA/ distilled water
Site: shoulder region
- Frequency of applications: single application
Topical Application (day 7)
A filter paper patch (WHATMAN No.4: approximate size 40 mm x 20 mm), saturated with the test material formulation (25% w/w in distilled water) was applied to the clipped skin and held in contact with an occlusive dressing for 48 hours.
Control Group: A patch was fully loaded with 0.5 mL of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.
B. CHALLENGE EXPOSURE (day 21)
A square filter paper patch (WHATMAN No.4: approximate size 40 mm x 20 mm), saturated with the test material formulation at the maximum non-irritant concentration (25% w/w in distilled water) was applied to the shorn right flank of each animal and held in contact with an occlusive dressing for 24 hours. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 10% w/w in distilled water was similarly applied to a skin site on the left shorn flank.
After 24 hours, the dressing was carefully removed and discarded. The challenge sites were swabbed with cotton wool soaked in distilled water to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen.
Approximately 24 and 48 hours after challenge dressing removal, the degree of erythema and oedema was quantified. - Challenge controls:
- The test material at a concentration of 10%w/w in distilied water was similarly applied to a skin site on the left shorn flank.
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole, a-Hexylcinnamaldehyde. The recent reliability checks were performed between 1998 and 2001 (positive control data for 6 studies documented in report).
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive control substance Mercaptobenzothiazole (5 -10 % in arachis oil BP) was between 90 and 100 %, the sensitisation rate after application of the positive control substance a-Hexylcinnamaldehyde (5 % in arachis oil BP) was between 40 and 50 % confirming the liability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy to moderate and confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy to moderate and confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- discrete or patchy erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy to moderate and confluent erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy to moderate and confluent erythema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Intradermal Sighting Test - Summary of Results
Animal Identification |
Time of Observation |
Concentration of Test Material |
Grade of Erythema at Injection Sites |
Evidence of System ic Toxicity
|
A |
24 hours 48 hours 72 hours 7 days |
1 |
1 0 0 0 |
None None None None
|
B |
24 hours 48 hours 72 hours 7 days |
5 |
2 1 0 0 |
None None None None
|
C |
24 hours 48 hours 72 hours 7 days |
10 |
2E 2E 2E * |
None None None *
|
D |
24 hours 48 hours 72 hours 7 days |
25 |
NE NE NE * |
None None None *
|
E=Eschar N=Dark grey/black-coloured necrosis*=Animal killed for humane reasons due to severity of dermal reactions
Topical Sighting Test for Induction Application (48-Hour Exposure) - Individual Skin Reactions
Animal Identification |
Concentration of Test Material |
Skin Reactions (Hours After Removal of Patches) |
||||||||
1 |
24 |
48 |
||||||||
ER |
Oe |
Other |
ER |
Oe |
Other |
ER |
Oe |
Other |
||
E |
75 50 25 10 |
3 3 2 2 |
2 1 1 1 |
BL - - - |
2 2 2 1 |
2 2 1 0 |
StCf StCf Cf - |
2 2 1 0 |
2 2 0 0 |
StCf StCf Cf - |
F |
75 50 25 10 |
2 2 2 2 |
1 1 0 0 |
- - - - |
2 2 2 1 |
1 0 0 0 |
- - - - |
1 1 0 0 |
0 0 0 0 |
- - - - |
Er=Erythema, Oe=Oedema
BI=Blanching of the skin
Cf=Crust formation
- =No other reactions noted
St=Hardened dark brown / black-coloured scabs
Topical Sighting Test for Challenge Application (24-Hour Exposure) - Individual Skin Reactions
Animal Identification |
Concentration of Test Material |
Skin Reactions (Hours After Removal of Patches) |
||||||||
1 |
24 |
48 |
||||||||
ER |
Oe |
Other |
ER |
Oe |
Other |
ER |
Oe |
Other |
||
G |
50 25 10 5 |
2 2 2 1 |
0 0 0 0 |
- - - - |
1 0 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
H |
50 25 10 5 |
2 2 2 1 |
0 0 0 0 |
- - - - |
1 0 0 0 |
0 0 0 0 |
- - - - |
0 0 0 0 |
0 0 0 0 |
- - - - |
Er=Erythema, Oe=Oedema
- =No other reactions noted
Intradermal Induction - Individual Skin Reactions
Group |
Animal Number
|
Grade of Erythema at Observation Site |
|||
24 Hours |
48 Hours
|
||||
Left Side |
Right Side |
Left Side |
Right Side
|
||
Test |
1 2 3 4 5 6 7 8 9 10 |
2 2 2 2 1 2 2 2 2 2 |
2 1 2 2 2 1 2 2 2 2 |
2 1 1 1 1 1 1 1 1 1 |
2 1 1 1 1 1 1 1 1 1 |
Control |
11 12 13 14 15 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
Topical Induction - Individual Skin Reactions
Group |
Animal Number
|
Skin Reactions (Hours After Removal of Dressing) |
|||||
1 hour |
24 hours |
||||||
ER |
Oe |
Other |
ER |
Oe |
Other |
||
Test |
1 2 3 4 5 6 7 8 9 10 |
2 2 2 2 2 2 2 2 2 2 |
0 1 0 0 0 1 0 1 1 1 |
BS BS BS BS BS BS BS BS BS BS |
2 2 2 2 2 2 2 2 2 2 |
0 0 0 0 0 0 0 0 0 0 |
- - - - - - - - - - |
Control |
11 12 13 14 15 |
1 1 1 1 1 |
0 0 0 0 0 |
BS BS BS BS - |
0 0 0 0 0 |
0 0 0 0 0 |
- - - - - |
Er=Erythema, Oe=Oedema
Bs=Bleeding from intradermal injection sites
- =No other reactions noted
Individual Bodyweights and Bodyweight Gains
Bodyweight increases of the guinea pigs in the test group between Day 0 and Day 24 were comparable to those noted in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- In this study, sodium dicyanoamide (a.i. 97.5 %) is a strong dermal sensitiser (90 % positive reactions at 5 % intradermal induction dose). The response in the GPMT assay was > 60% and the substance was not tested at ≤ 1 % intradermal induction dose in the guinea pig maximisation test. Although the criteria for classification to subcategory 1B are fulfilled, the classification for subcategory 1A cannot be excluded and therefore the substance is classified as a Category 1 skin sensitiser.
- Executive summary:
In a dermal sensitisation study according to OECD TG 406, 1992) with Sodium dicyanoamide (a.i. 97.5 %) in distilled water, young adult Dunkin-Hartley guinea pigs were tested using the Maximization test method. Positive control substances were mercaptobenzothiazole with a sensitisation rate of 90 - 100 % and α-hexylcinnamaldehyde with a sensitisation rate of 40 – 50%.
Mild to moderate skin reactions were observed after intradermal induction (5 %) and dermal induction (25 %) in the test substance animals. After challenge exposure (25 %) positive responses (discrete or patchy to moderate and confluent erythema) were noted in test group animals at the 24 and 48-hour observations.
Transient challenge reactions (discrete or patchy erythema) were noted at the challenge sites of two control group animals at the 24-hour observations. No skin reactions were observed in control animals at the 48-hour observation time. Therefore the sensitisation rate was 90 %.
In this study sodium dicyanoamide gave a positive response in a guinea pig maximisation test with 90 % responding at 5 % intradermal induction dose. The response in the GPMT assay was > 60% and the substance was not tested at ≤ 1 % intradermal induction dose in the guinea pig maximisation test. Although the criteria for classification to subcategory 1B are fulfilled, the classification for subcategory 1A cannot be excluded and therefore the substance is classified as a Category 1 skin sensitiser.
In this study, sodium dicyanoamide (a.i. 97.5 %), is a strong dermal sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.