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EC number: 214-447-6 | CAS number: 1129-42-6
- 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:
- 117.11 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 927.82 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data are available for the inhalation route. However, reliable data from a structural analogue substance (CAS 6104-30-9) are available for the oral route.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default (worker)
- AF for the quality of the whole database:
- 1
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 166.06 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 660.55 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No data are available for the dermal route. However, reliable data from a structural analogue substance (CAS 6104-30-9) are available for the oral route.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default (rat/human)
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default (worker)
- AF for the quality of the whole database:
- 1
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
No long term toxicity data are available for the submission substance, however, reliable data are available for the structural analogue substance (CAS 6104-30-9).
In the available Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test the structural analogue substance CAS 6104-30-9 was investigated for toxicity after repeated oral exposure (CIT, 2003a). The study was conducted according to OECD 422, and in compliance with GLP. 10 Sprague-Dawley rats per sex per dose received the test item in carboxymethyl cellulose via gavage at doses of 100, 300, and 1000 mg/kg bw/day. Males were treated throughout pre-mating (15 days), and during the mating and post-mating periods until sacrifice (34 days in total). Females received the test material throughout pre-mating (15 days) and mating period, during pregnancy and lactation, and until day 4 post partum. Treatment was conducted once daily for 7 days per week; concurrent controls received the vehicle only. Treatment with the test material did not result in any adverse effects of toxicological relevance for human health, neither for systemic toxicity, nor for toxicity to reproduction. Therefore, a NOAEL of 1000 mg/kg bw/day for both systemic toxicity and reproductive toxicity was deduced.
Further information from the structural analogue substance CAS 6104-30-9 was obtained from a study performed to investigate the toxicity to reproduction (CIT, 2003b).The one-generation study was conducted similar to the OECD test guidelines 416 and 421, and in compliance with GLP. 25 Sprague-Dawley rats per sex per dose received the test substance in carboxymethyl cellulose via gavage at doses of 600 mg/kg bw/day and 1200 mg/kg bw/day. Males were treated throughout the pre-mating period (10 weeks), mating period (2 weeks), and until sacrifice; the females received the test material throughout the pre-mating period (10 weeks), mating period (2 weeks), and pregnancy until day 14 post-coitum inclusive. Treatment was carried out daily on 7 days per week, and concurrent controls received the vehicle only. Treatment with the test material did not result in any adverse effects of toxicological relevance for human health. Therefore, a NOAEL of 1200 mg/kg bw/day for both maternal and developmental toxicity was deduced.
The available developmental toxicity/teratogenicity study (BASF AG, 1993) with the structural analogue substance CAS 6104-30-9 was conducted according to OECD 414 and in compliance with GLP. 25 naive female Wistar rats were mated in a ratio of 1/4 with respective naive males by cohousing overnight, and treated with the test substance via gavage from gestation days 6 -15. The test material was administered as a suspension in 0.5% aqueous carboxymethyl cellulose solution at doses of 100, 400, and 1000 mg/kg bw/day once daily on 7 days/week. The doses applied were selected on the basis of the outcome of a preliminary range-finding study. No test material-related effects were seen throughout the study period, neither in dams, nor in pups. Thus, the NOAEL for both the maternal and foetal organism was set at 1000 mg/kg bw/day.
In conclusion, the NOAEL of 1200 mg/kg bw/day deduced from the one-generation reproductive toxicity study (CIT, 2003b) was used for the risk assessment, since this value was obtained from the study with the longest exposure duration and is therefore considered to be the most reliable dose descriptor.
Workers - hazard via inhalation route - systemic effects - long term exposure
The long term DNEL for systemic toxicity via the inhalation route is determined by route-to route extropolation on the basis of NOAEL of 1200 mg/kg bw/day revealed from the one-generation reproductive toxicity study with the structural analogue substance CAS 6104 30-9 (CIT, 2003b).
The following correction was made to the NOAEL:
Based on the different molecular weights of 6-methyl-2-oxoperhydropyrimidin-4-yl urea (CAS 1129-42-6; 172.1851 g/mol) and the analogue substance N,N''-(isobutylidene)diurea (CAS 6104-30-9; 174.2010 g/mol), the NOAEL was corrected to 1186.11 mg/kg bw/day (MW correction target/source=172.1851 g/mol/174.2010 g/mol=0.988; 1200 mg/kg bw/day×0.988=1186.11 mg/kg bw/day).
No correction for relative absorption oral vs. inhalation: 1
Correction for number of exposures per week: 7d/5d
Correction for respiratory volume (rat/worker): 0.38 m³/kg bw (8 h)
Correction for respiratory volume (worker, light physical activity): 6.7 m³/10 m³
Therefore the corrected NOAEC for repeated-dose systemic effects via inhalation is:
1186.11 mg/kg bw/day×7/5×1/0.38 m³/kg bw ×(6.7 m³/10 m³)=2927.82 mg/m³/day
The following assessment factors were applied to the corrected NOAEC:
Exposure duration (subchronic to chronic): 2 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Intraspecies differences (worker): 5 (default)
Total AF: 2×2.5×5=25
The overall DNEL (repeated-dose – systemic – inhalation - worker) is therefore:
2927.82 mg/m³/day/25=117.11 mg/m³/day.
Workers- hazard via dermal route - systemic effects - long term exposure
The long term DNEL for systemic toxicity via the inhalation route is determined by route-to route extropolation on the basis of NOAEL of 1200 mg/kg bw/day revealed from the one-generation reproductive toxicity study with the structural analogue substance CAS 6104 30-9 (CIT, 2003b).
The following correction was made to the NOAEL:
Based on the different molecular weights of 6-methyl-2-oxoperhydropyrimidin-4-yl urea (CAS 1129-42-6; 172.1851 g/mol) and the analogue substance N,N''-(isobutylidene)diurea (CAS 6104-30-9; 174.2010 g/mol), the NOAEL was corrected to 1186.11 mg/kg bw/day (MW correction target/source=172.1851 g/mol/174.2010 g/mol=0.988; 1200 mg/kg bw/day×0.988=1186.11 mg/kg bw/day).
No correction for relative absorption oral vs. dermal: 1
Correction for number of exposures per week: 7d/5d
Therefore the corrected NOAEL for repeated-dose systemic effects via the dermal route is:
1186.11 mg/kg bw/day×7/5=1660.55 mg/kg bw/day
The following assessment factors were applied to the systemic NOAEL:
Exposure duration (subacute to chronic): 2 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Interspecies differences (toxicokinetics, rat/human): 4 (default)
Intraspecies differences (worker): 5 (default)
Total AF: 2×2.5×4×5=100
The overall DNEL (repeated-dose – systemic – dermal - worker) is therefore:
1660.55 mg/kg bw/day/100=166.06 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.63 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 031.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data are available for the inhalation route. However, reliable data from a structural analogue substance (CAS 6104-30-9) are available for the oral route.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- defaullt
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- defaullt
- AF for intraspecies differences:
- 10
- Justification:
- defaullt (general population)
- AF for the quality of the whole database:
- 1
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.93 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 186.11 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No data are available for the dermal route. However, reliable data from a structural analogue substance (CAS 6104-30-9) are available for the oral route.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default (rat/human)
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (worker)
- AF for the quality of the whole database:
- 1
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.93 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 186.11 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default (rat/human)
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (general population)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
No long term toxicity data are available for the submission substance, however, reliable data are available for the structural analogue substance (CAS 6104-30-9).
In the available Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test the structural analogue substance CAS 6104-30-9 was investigated for toxicity after repeated oral exposure (CIT, 2003a). The study was conducted according to OECD 422, and in compliance with GLP. 10 Sprague-Dawley rats per sex per dose received the test item in carboxymethyl cellulose via gavage at doses of 100, 300, and 1000 mg/kg bw/day. Males were treated throughout pre-mating (15 days), and during the mating and post-mating periods until sacrifice (34 days in total). Females received the test material throughout pre-mating (15 days) and mating period, during pregnancy and lactation, and until day 4 post partum. Treatmentwas conducted once daily for 7 days per week; concurrent controls received the vehicle only. Treatment with the test material did not result in any adverse effects of toxicological relevance for human health, neither for systemic toxicity, nor for toxicity to reproduction. Therefore, a NOAEL of 1000 mg/kg bw/day for both systemic toxicity and reproductive toxicity was deduced.
Further information from the structural analogue substance CAS 6104-30-9 was obtained from a study performed to investigate the toxicity to reproduction (CIT, 2003b).The one-generation study was conducted similar to the OECD test guidelines 416 and 421, and in compliance with GLP. 25 Sprague-Dawley rats per sex per dose received the test substance in carboxymethyl cellulose via gavage at doses of 600 mg/kg bw/day and 1200 mg/kg bw/day.Males were treated throughout the pre-mating period (10 weeks), mating period (2 weeks), and until sacrifice; the females received the test material throughout the pre-mating period (10 weeks), mating period (2 weeks), and pregnancy until day 14 post-coitum inclusive. Treatment was carried out daily on 7 days per week, and concurrent controls received the vehicle only.Treatment with the test material did not result in any adverse effects of toxicological relevance for human health. Therefore, a NOAEL of 1200 mg/kg bw/day for both maternal and developmental toxicity was deduced.
The available developmental toxicity/teratogenicity study (BASF AG, 1993) with the structural analogue substance CAS 6104-30-9 was conducted according to OECD 414 and in compliance with GLP. 25 naive female Wistar rats were mated in a ratio of 1/4 with respective naive males by cohousing overnight, and treated with the test substance via gavage from gestation days 6 -15. The test material was administered as a suspension in 0.5%aqueous carboxymethyl cellulose solution at doses of 100, 400, and 1000 mg/kg bw/day once daily on 7 days/week. The doses applied were selected on the basis of the outcome of a preliminary range-finding study. No test material-related effects were seen throughout the study period, neither in dams, nor in pups. Thus, the NOAEL for both the maternal and foetal organism was set at 1000 mg/kg bw/day.
In conclusion, the NOAEL of 1200 mg/kg bw/day deduced from the one-generation reproductive toxicity study (CIT, 2003b) was used for the risk assessment, since this value was obtained from the study with the longest exposure duration and is therefore considered to be the most reliable dose descriptor.
General population - hazard via inhalation route - systemic effects - long term exposure
The long term DNEL for systemic toxicity via the inhalation route is determined by route-to route extropolation on the basis of NOAEL of 1200 mg/kg bw/day revealed from the one-generation reproductive toxicity study with the structural analogue substance CAS 6104 30-9 (CIT, 2003b).
The following correction was made to the NOAEL:
Based on the different molecular weights of 6-methyl-2-oxoperhydropyrimidin-4-yl urea (CAS 1129-42-6; 172.1851 g/mol) and the analogue substance N,N''-(isobutylidene)diurea (CAS 6104-30-9; 174.2010 g/mol), the NOAEL was corrected to 1186.11 mg/kg bw/day (MW correction target/source=172.1851 g/mol/174.2010 g/mol=0.988; 1200 mg/kg bw/day×0.988=1186.11 mg/kg bw/day).
No correction for relative absorption oral vs. inhalation: 1
Correction for respiratory volume (rat/general population): 1.15 m³/kg bw (24 h)
Therefore the corrected NOAEC for repeated-dose systemic effects via inhalation is:
1186.11 mg/kg bw/day×1/1.15 m³/kg bw=1031.40 mg/m³/day
The following assessment factors were applied to the corrected NOAEC:
Exposure duration (subchronic to chronic): 2 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Intraspecies differences (general population): 10 (default)
Total AF: 2×2.5×10=50
The overall DNEL (repeated-dose – systemic – inhalation - general population) is therefore:
1031.40 mg/m³/day/50=20.63 mg/m³/day.
General population- hazard via dermal route - systemic effects - long term exposure
The long term DNEL for systemic toxicity via the inhalation route is determined by route-to route extropolation on the basis of NOAEL of 1200 mg/kg bw/day revealed from the one-generation reproductive toxicity study with the structural analogue substance CAS 6104 30-9 (CIT, 2003b).
The following correction was made to the NOAEL:
Based on the different molecular weights of 6-methyl-2-oxoperhydropyrimidin-4-yl urea (CAS 1129-42-6; 172.1851 g/mol) and the analogue substance N,N''-(isobutylidene)diurea (CAS 6104-30-9; 174.2010 g/mol), the NOAEL was corrected to 1186.11 mg/kg bw/day (MW correction target/source=172.1851 g/mol/174.2010 g/mol=0.988; 1200 mg/kg bw/day×0.988=1186.11 mg/kg bw/day).
No correction for relative absorption oral vs. dermal: 1
Therefore the corrected NOAEL for repeated-dose systemic effects via the dermal route is:
1186.11 mg/kg bw/day×1=1186.11 mg/kg bw/day
The following assessment factors were applied to the systemic NOAEL:
Exposure duration (subacute to chronic): 2 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Interspecies differences (toxicokinetics, rat/human): 4 (default)
Intraspecies differences (general population): 10 (default)
Total AF: 2×2.5×4×10=200
The overall DNEL (repeated-dose – systemic – dermal - general population) is therefore:
1186.11 mg/kg bw/day/200=5.93 mg/kg bw/day.
General population - hazard via oral route - systemic effects - long term exposure
The long term DNEL for systemic toxicity via the inhalation route is determined on the basis of NOAEL of 1200 mg/kg bw/day revealed from the one-generation reproductive toxicity study with the structural analogue substance CAS 6104 30-9 (CIT, 2003b).
The following correction was made to the NOAEL:
Based on the different molecular weights of 6-methyl-2-oxoperhydropyrimidin-4-yl urea (CAS 1129-42-6; 172.1851 g/mol) and the analogue substance N,N''-(isobutylidene)diurea (CAS 6104-30-9; 174.2010 g/mol), the NOAEL was corrected to 1186.11 mg/kg bw/day (MW correction target/source=172.1851 g/mol/174.2010 g/mol=0.988; 1200 mg/kg bw/day×0.988=1186.11 mg/kg bw/day).
Therefore the corrected NOAEL is 1186.11 mg/kg bw/day.
The following assessment factors were applied to the corrected NOAEL:
Exposure duration (subacute to chronic): 2 (default)
Interspecies differences (toxicodynamics): 2.5 (default)
Interspecies differences (toxicokinetics, rat/human): 4 (default)
Intraspecies differences (general population): 10 (default)
Total AF: 2×2.5×4×10=200
The overall DNEL (repeated-dose – systemic – dermal - general population) is therefore:
1186.11 mg/kg bw/day/200=5.93 mg/kg bw/day.
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