Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 418-280-1 | CAS number: 18600-59-4 CYASORB(R) UV-3638 LIGHT STABILISER
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.247 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 18.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 70 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 21 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute/Short-term systemic effects
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that worker-DNEL acute dermal systemic effects do not need to be derived for substances that are not classified for an acute toxicity hazard. As Chiguard 380/Chiguard 380W is not classified for acute dermal toxicity, noworker-DNEL acute dermal systemic effectsneed to be derived.
Acute Short-term local effects
Chiguard 380/Chiguard 380W is classified as Sensitisation (Xi, R43) when considering the criteria outlined in Annex VI of 67/548/EEC and classified as Skin Sens. 1B when considering the criteria outlined in Annex I of 1272/2008/EC and its adaption (EU) No 286/2011. DNEL for acute dermal local effects is required. But there is no NOAEL available, so DNEL acute dermal local effects could not be derived.
Long-term systemic effects
From the available studies, a NOAEL for repeated dose toxicity study (EU Method B.7) is used as the starting point for DNEL calculations.
DNEL Long-term systemic effects for dermal route
Starting point: NOAEL 15 mg/kg bw/day from oral route
Correction for differences between human and experimental exposure conditions (workers):1.4
Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
Corrected NOAEL: 21 mg/kg bw/day
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 5
Differences in duration of exposure (sub-acute study to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 300
=>Worker DNEL long-term for dermal route-systemic: 0.07 mg/kg bw/day
DNEL long-term systemic for inhalation route
Starting point: NOAEL 15 mg/kg bw/day from oral route
Correction for differences between human and experimental exposure conditions (workers):1.4
Respiratory volume rat (sRV) (worker (8 h): 1/0.38): 2.632
Differences in respiratory volume (default factor "light activity worker"): 0.67
Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
=>Corrected NOAEC: 18.51 mg/m3
Interspecies differences: Allometric scaling: 1
Remaining interspecies differences: 2.5
Intraspecies differences: 5
Differences in duration of exposure (sub-acute study to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 75
=>Worker DNEL long-term for inhalation route-systemic: 0.247 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.5 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 6.53 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- 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:
- 25 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute/Short-term systemic effects
The guidance on dose/concentration response regarding human health (section R8.1.2.5 of chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified for an acute toxicity hazard. As Chiguard 380/Chiguard 380W is not classified for acute toxicity hazards, no acute DNELs need to be calculated.
Acute Short-term local effects
Chiguard 380/Chiguard 380W is classified as Sensitisation (Xi, R43) when considering the criteria outlined in Annex VI of 67/548/EEC and classified as Skin Sens. 1 when considering the criteria outlined in Annex I of 1272/2008/EC and its adaption (EU) No 286/2011. DNEL for acute short-term local effects is required. But there is no NOAEL available, so DNEL acute short-term local effects could not be derived.
Long-term systemic effects
From the available studies, a NOAEL for 28 -day repeated dose oral toxicity study (EU Method B.7) is used as the starting point for DNEL calculations.
DNEL Long-term systemic effects for oral route
Starting point: NOAEL 15 mg/kg bw/day from 28-day repeated dose oral toxicity study
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute study to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 600
=>General population DNEL long-term for oral route-systemic: 0.025 mg/kg bw/day
DNEL Long-term systemic effects for dermal route
Starting point: NOAEL 15 mg/kg bw/day from 28-day repeated dose oral toxicity study
Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
Corrected NOAEL: 15 mg/kg bw/day
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute study to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 600
=> General population DNEL long-term for dermal route-systemic: 0.025 mg/kg bw/day
DNEL long-term systemic for inhalation route
Starting point: NOAEL 15 mg/kg bw/day from 28-day repeated dose oral toxicity study
Respiratory volume rat (sRV) (general population (24 h): 1/1.15): 0.8696
Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
=>Corrected NOAEC: 6.522 mg/m3
Interspecies differences: Allometric scaling: 1
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute study to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 150
=>General populationDNEL long-term for inhalation route-systemic: 0.0435 mg/m3
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.
