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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-992-3 | CAS number: 420-04-2
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: MAK-Begründung Cyanamid, 52. Lieferung 2012
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 7
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.67 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For risk characterisation a dermal NOEL was derived by route to route extrapolation. The oral NOAEL of 1 mg/kg bw/day, obtained from chronic repeated dose toxicity testing in dogs by Osheroff (1991), was considered reliable and was chosen as key value for the chemical safety assessment and therefore, most relevant starting point. Based on the results obtained from dermal absorption testing (see IUCLID section 7.1) a dermal absorption rate of 30 % through skin was deduced.
Oral absorption of the dog/ dermal absorption of humans (ABS oral-dog / ABS derm-human): 1/0.3
Correction for difference between human and experimental exposure conditions: 7 d dog/5 d worker
Corrected NOAEL (dermal) for workers:
NOAELcorr = NOAELoral x 7d/5d x ABSoral/ABSderm
NOAELcorr = 1 mg/kg bw/day x 7d/5d x 1/0.3
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a chronic toxicity study is available.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dog and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Substance-specific information shows specific susceptibility differences between species, which are not related to differences in basal metabolic rate, the additional factor of 2.5 for ‘remaining differences’ was reduced to 1. For more details and justification please refer to IUCLID section 7.1.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.01 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: DNEL
- Value:
- 0.67 mg/kg bw/day
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General
Cyanamide revealed toxic systemic effects during acute and long-term toxicity testing. Adverse effects occurred during acute oral and dermal application as well as long-term oral, inhalation and dermal application. Moreover, the substance was tested corrosive to skin and eyes as well as skin sensitising. DNELs were derived for acute dermal as well as long-term dermal and long-term inhalation exposure but limited to systemic effects.
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2010). In view of the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.
Systemic long-term DNEL for inhalation exposure
For the the DNEL long-term, inhalation the conservative German MAK-value of 0.35 mg/m³ (MAK-Begründung Cyanamid, 52. Lieferung 2012) derived from the one year dog study was applied.
Calculations according to ECHA Guidance Document on Information Requirement, Chapter R8, based on the available chonic dog study by Osheroff (1991) result in slightly higher figures:
Standard body weight human: 70 kg
Allometric scaling factor (ASF) dog: 1,4
Worker respiratory volume (wRV) for 8 hours with light physical activity per person: 10 m3
Oral absorption of the dog/ inhalation absorption of humans (ABS oral-dog / ABS inh.-human): 1/2
Correction for difference between human and experimental exposure conditions: 7 d dog/5 d worker
Corrected NOAEC (inhalation) for workers:
NOAECcorr = NOAELoral / ASF x 70 kg / 10m³ x 7d/5d x ABSoral/ABSinh
NOAECcorr = 1 mg/kg bw/d / 1,4 x 70 kg / 10m³ x 7d/5d x 1/2
= 3.5 mg/m³
(NOAECcorr/ SF= 3.5 mg/ m³ / 5* = 0.7 mg/m³ )
*intraspecies default factor for population "worker"
Systemic acute DNEL for inhalation exposure
A reliable acute inhalation toxicity study in rats resulted in a LC50 of 1000 mg/m3. Based on this result, cyanamide is not classified and labelled for acute inhalation systemic toxicity, according to Regulation EC 1272/2008 (CLP). Systemic effects through high peak-inhalation exposure are therefore not likely to occur, so that no hazard could be identified.
Local long-term and acute DNELs for inhalation exposure
Due to classification of cyanamide as skin corrosive, Cat. 1B, eye damage Cat. 1 and skin sensitising Cat. 1 according to Regulation (EC) No 1272/2008 (CLP) and association to the medium hazard band, local long-term effects are likely to occur.
No local long-term systemic DNEL for inhalation was derived as the possibly occurring effects are fully covered by the long-term risk assessment using the long-term systemic inhalation DNEL.
Systemic long-term DNEL for dermal exposure
The oral NOAEL of 1 mg/kg bw/day from a chronic oral dog study by Osheroff (1991) was used as POD. A route-to-route extrapolation to a dermal NOEL was conducted. Based on the results obtained from dermal absorption testing (see IUCLID section 7.1) a dermal absorption rate of 30 % through skin was deduced. It was additionally modified using a correction for difference between human and experimental exposure conditions (7 days exposure of the rats/5 days exposure of worker per week) to 4.67 mg/kg bw/day using the equation provided in the Guidance Document on Information Requirement, Chapter R8:
NOAELcorr = NO(A)ELdermal x 7d/5d x ABSoral/ABSderm
Using assessment factors of (i) 1.4 for interspecies differences (allometric scaling), (ii) 1 for remaining interspecies differences and (iii) 5 for intraspecies extrapolation, a DNEL of 0.67 mg/kg bw/day for long-term, systemic dermal exposure was calculated.
Systemic acute DNEL for dermal exposure
In an acute dermal toxicity study, the NOAEL was 848 mg/kg bw/day. Therefore hazard could be identified and the determination of a DNEL for acute oral toxicity triggered. The DNEL was derived on the basis of a long-term DNEL of 0.67 mg/kg bw/day and in accordance with ECHA Guidance R.8 Dose- or concentration-response characterisation (2012).
dermal DNELacute = long-term DNEL x 1-5
To derive a dermal DNEL for acute toxicity a reasonable worst case assumption for the AF of 3 has been made and a dermal DNELacute of 2 mg/kg bw/day was determined.
Local long-term and acute DNELs for dermal exposure
Hazard was identified in skin sensitisation studies. Thus, long-term and acute local dermal effects are likely to occur. The long-term inhalation and dermal DNELs for local effects were not derived. A potency categorisation into high hazard (> 80 % animals responding at > 1 % intradermal induction dose) applies for the neat substance or mixtures containing the substance in quantities of equal to or more than 1 %, taking into account the generic concentration limits that trigger classification of a mixture as given in Table 3.4.5 of Commission Regulation (EU) No 286/2011.
Hazard to the eyes:
Cyanamid is classified as eye damage Cat. 1. according to Regulation (EC) No 1272/2008 (CLP) and associated to the medium Hazard Band. A qualitative risk assessment is conducted.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.125 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL long-term, inhalation was derived by route to route extrapolation from the oral NOAEL of 1 mg/kg bw/day.
Standard body weight human: 70 kg
Allometric scaling factor (ASF) dog: 1,4
General population respiratory volume (wRV) per person for 24 hours: 20 m3
Oral absorption of the dog/ inhalation absorption of humans (ABS oral-dog / ABS inh.-human): ½ (default)
Corrected NOAEC (inhalation) for the general population:
NOAECcorr = NOAELoral / ASF x 70 kg / 20m³ x ABSoral/ABSinh
NOAECcorr = 1 mg/kg bw/d / 1,4 x 70 kg / 20m³ x 1/2
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a chronic toxicity study is available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.24 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 14
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3.33 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For risk characterisation a dermal NOEL was derived by route to route extrapolation. The oral NOAEL of 1 mg/kg bw/day, obtained from chronic repeated dose toxicity testing in dogs by Osheroff (1991), was considered as key value for the chemical safety assessment and therefore, most relevant starting point. Based on the results obtained from dermal absorption testing (see IUCLID section 7.1) a dermal absorption rate of 30 % through skin was deduced.
Oral absorption of the dog/ dermal absorption of humans (ABS oral-dog / ABS derm-human): 1/0.3
Corrected NOAEL (dermal) for general population:
NOAELcorr = NOAELoral x ABSoral/ABSinh
NOAELcorr = 1 mg/kg bw/day x 1/0.3
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a chronic toxicity study is available.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dog and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Substance-specific information shows specific susceptibility differences between species, which are not related to differences in basal metabolic rate, the additional factor of 2.5 for ‘remaining differences’ was modified. For more details and justification please refer to IUCLID section 7.1.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.72 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: DNEL
- Value:
- 0.24 mg/kg bw/day
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.072 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 14
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is necessary since a repeated dose oral toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a chronic toxicity study is available.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dog and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- Substance-specific information shows specific susceptibility differences between species, which are not related to differences in basal metabolic rate, the additional factor of 2.5 for ‘remaining differences’ was modified. For more details and justification please refer to IUCLID section 7.1.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.216 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: DNEL systemic, oral, long-term
- Value:
- 0.072 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification was necessary as the starting point (DNEL oral, systemic, long-term) was obtained from an oral toxicity study.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
General
Cyanamide revealed toxic systemic effects during acute and long-term toxicity testing. Adverse effects occurred during acute oral and dermal application as well as long-term oral, inhalation and dermal application. Moreover, the substance was tested corrosive to skin and eyes as well as skin sensitising. DNELs were derived for acute dermal as well as long-term dermal and long-term inhalation exposure but limited to systemic effects.
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2010). In view of the data used for evaluation, the "quality of whole database factors" and "dose response factors" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.
Systemic long-term DNEL for inhalation exposure
The oral NOAEL of 1 mg/kg bw/day from a chronic oral dog study by Osheroff (1991) was used as POD. This NOEL was confirmed by the recent RAC evaluation. For risk characterisation a dermal NOEL was derived by route to route extrapolation. It was modified using the ASF of 1,4 for the differences between the dog and a human, a human standard respiratory volume (sRV) of 20 m3 for 24 hours, default body weight of 70 kg for an adult and the default quotient of ½ for oral absorption of the dog and inhalation absorption of humans (ABS oral-dog / ABS inh-human) to 0.125 mg/m³ using the equation provided in the Guidance Document on Information Requirement, Chapter R8.
NOECcorr = NOAELoral x 1.4 / 20 m³ x 70 kg x ABSoral/ABSinh
Using assessment factors of (i) 1 for remaining interspecies differences and (ii) 10 for intraspecies extrapolation, a DNEL of 0.125 mg/m³ for long term, systemic dermal exposure was calculated.
Systemic acute DNEL for inhalation exposure
A reliable acute inhalation toxicity study in rats resulted in a LC50 of 1000 mg/m3. Based on this result, cyanamide is not classified and labelled for acute inhalation systemic toxicity, according to Regulation EC 1272/2008 (CLP). Systemic effects through high peak-inhalation exposure are therefore not likely to occur, so that no hazard could be identified.
Local long-term and acute DNELs for inhalation exposure
Due to classification of Cyanamide as skin corrosive, Cat. 1B, eye damage Cat. 1 and skin sensitising Cat. 1 according to Regulation (EC) No 1272/2008 (CLP) and association to the medium hazard band, local long-term effects are likely to occur. No local long-term systemic DNEL for inhalation was derived as the possibly occurring effects are fully covered by the long-term risk assessment using the long-term systemic inhalation DNEL.
Systemic long-term DNEL for dermal exposure
The oral NOAEL of 1 mg/kg bw/day from a chronic oral dog study by Osheroff (1991) was used as POD. A route-to-route extrapolation to a dermal NOEL was conducted. Based on the results obtained from dermal absorption testing (see IUCLID section 7.1) a dermal absorption rate of 30 % through skin was deduced. It was additionally modified using a correction for difference between human and experimental exposure conditions to 3.33 mg/kg bw/ day using the equation provided in the Guidance Document on Information Requirement, Chapter R8:
NOAELcorr = NO(A)ELdermal x ABSoral/ABSderm
Using assessment factors of (i) 1.4 for interspecies differences (allometric scaling), (ii) 1 for remaining interspecies differences and (iii) 10 for intraspecies extrapolation, a DNEL of 0.24 mg/kg bw/day for long term, systemic dermal exposure was calculated.
Systemic acute DNEL for dermal exposure
In an acute dermal toxicity study, the NOAEL was 848 mg/kg bw/day. Therefore hazard could be identified and the determination of a DNEL for acute dermal toxicity triggered. The DNEL was derived on the basis of a long-term DNEL of 0.24 mg/kg bw/day and in accordance with ECHA Guidance R.8 Dose- or concentration-response characterisation (2012).
dermal DNELacute = long-term DNEL x 1-5
To derive a dermal DNEL for acute toxicity a reasonable worst case assumption for the AF of 3 has been made and a dermal DNELacute of 0.72 mg/kg bw/day was determined.
Local long-term and acute DNELs for dermal exposure
Hazard was identified in skin sensitisation studies. Thus, long-term and acute local dermal effects are likely to occur. The long-term inhalation and dermal DNELs for local effects were not derived. A potency categorisation into high hazard (> 80 % animals responding at > 1 % intradermal induction dose) applies for the neat substance or mixtures containing the substance in quantities of equal to or more than 1 %, taking into account the generic concentration limits that trigger classification of a mixture as given in Table 3.4.5 of Commission Regulation (EU) No 286/2011.
Systemic long-term DNEL for oral exposure
The oral NOAEL of 1 mg/kg bw/day from a chronic oral dog study by Osheroff (1991) was used as POD. No further modification was necessary.
Using assessment factors according to CSA Guidance Document Chapter R.8, December 2010 of (i) 1.4 for interspecies differences (allometric scaling), (ii) 1 for remaining interspecies differences and (iii) 10 for intraspecies extrapolation, a DNEL of 0.972 mg/kg bw/day for long term, systemic oral exposure was calculated.
Systemic acute DNEL for oral exposure
In an acute oral toxicity study, the NOAEL was 142 mg/kg bw/day. Therefore hazard could be identified and the determination of a DNEL for acute oral toxicity triggered. The DNEL was derived on the basis of a long-term DNEL of 0.072 mg/kg bw/day and in accordance with ECHA Guidance R.8 Dose- or concentration-response characterisation (2012).
oral DNELacute = long-term DNEL x 1-5
To derive a dermal DNEL for acute toxicity a reasonable worst case assumption for the AF of 3 has been made and a dermal DNELacute of 0.216 mg/kg bw/day was determined.
Local long-term and acute DNELs for dermal exposure
Hazard was identified in skin sensitisation studies. Thus, long-term and acute local dermal effects are likely to occur. The long-term inhalation and dermal DNELs for local effects were not derived. A potency categorisation into high hazard (> 80 % animals responding at > 1 % intradermal induction dose) applies for the neat substance or mixtures containing the substance in quantities of equal to or more than 1 %, taking into account the generic concentration limits that trigger classification of a mixture as given in Table 3.4.5 of Commission Regulation (EU) No 286/2011.
Hazard to the eyes:
Cyanamide is classified as eye damage Cat. 1. according to Regulation (EC) No 1272/2008 (CLP) and associated to the medium Hazard Band. A qualitative risk assessment is conducted.
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.