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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on epidemiological data
Overall assessment factor (AF):
1
Dose descriptor starting point:
NOAEC
Value:
1 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 mg/m³
AF for dose response relationship:
1
Justification:
based on epidemiological data
AF for differences in duration of exposure:
1
Justification:
based on epidemiological data
AF for interspecies differences (allometric scaling):
1
Justification:
based on epidemiological data
AF for other interspecies differences:
1
Justification:
based on epidemiological data
AF for intraspecies differences:
1
Justification:
based on epidemiological data
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
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:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.65 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):
20
Dose descriptor starting point:
NOAEL
Value:
1.3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
13 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In a dermal absorption human volunteer study cyanamide was applied over a 6-hour period topically to the skin of human volunteers and of the dosage applied, about 7.7% were found as acetylcyanamide in the urine 48 hours after application. For risk assessment and DNEL derivation it is assumed that dermal absorption is 10 % of oral absorption, based on these results.

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 assessment factor for duration of exposure is needed as the NOEC was derived from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
1
Justification:
Because the NOAEL is based on effects on the thyroid, and it was concluded by RAC that rodents are more sensitivity to the antithyroidal effects compared to humans, an additional interspecies AF of 2.5 (remaining differences) does not need to be applied.
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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on epidemiological data
Overall assessment factor (AF):
2
Dose descriptor starting point:
NOAEC
Value:
1 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
0.24 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction of NOAEC from a worker study (8 h/day for 5 days/week) is based on the exposure for general population (24 h/day for 7 days/week):

[Calculation: NOAEC(corr) = NOAEC (worker) x (8 h/day x 5 days/week)/(24 h/day x 7 days/week)]

AF for dose response relationship:
1
Justification:
based on epidemiological data
AF for differences in duration of exposure:
1
Justification:
based on epidemiological data
AF for interspecies differences (allometric scaling):
1
Justification:
based on epidemiological data
AF for other interspecies differences:
1
Justification:
based on epidemiological data
AF for intraspecies differences:
2
Justification:
An AF of 2 is applicable as a factor of 5 for differences within workers has already been taken into account deriving the OEL
AF for the quality of the whole database:
1
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)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.325 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):
40
Dose descriptor starting point:
NOAEL
Value:
1.3 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
13 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In a dermal absorption human volunteer study cyanamide was applied over a 6-hour period topically to the skin of human volunteers and of the dosage applied, about 7.7% were found as acetylcyanamide in the urine 48 hours after application. For risk assessment and DNEL derivation it is assumed that dermal absorption is 10 % of oral absorption, based on these results.

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 assessment factor for duration of exposure is needed as the NOEC was derived from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
1
Justification:
Because the NOAEL is based on effects on the thyroid, and it was concluded by RAC that rodents are more sensitivity to the antithyroidal effects compared to humans, an additional interspecies AF of 2.5 (remaining differences) does not need to be applied.
AF for intraspecies differences:
10
Justification:
The default value for the relatively homogenous 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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.033 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):
40
Dose descriptor starting point:
NOAEL
Value:
1.3 mg/kg bw/day
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 assessment factor for duration of exposure is needed as the NOEC was derived from a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
The default allometric scaling factor for the differences between rats and humans is used.
AF for other interspecies differences:
1
Justification:
Because the NOAEL is based on effects on the thyroid, and it was concluded by RAC that rodents are more sensitivity to the antithyroidal effects compared to humans, an additional interspecies AF of 2.5 (remaining differences) does not need to be applied.
AF for intraspecies differences:
10
Justification:
The default value for the relatively homogenous 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population