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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 292-059-6 | CAS number: 90530-20-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 37 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Please refer to "Additional Information".
- 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:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- 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:
- medium hazard (no threshold derived)
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:
- 0.14 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 42 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Please refer to "Additional Information".
- 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:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- 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:
- medium hazard (no threshold derived)
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
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA, Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose-response for human health (Version: 2.1, November 2012).
Inhalation
Long term, systemic DNEL – exposure via inhalation (workers)
Using a conservative approach, a worker DNEL (long-term inhalation exposure) is calculated. This worker long-term DNEL is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).
No repeated dose inhalation toxicity study with CeTePox® 0214 H is available. Therefore, it will be necessary to obtain a long-term DNEL by route-to-route extrapolation:
An OECD TG 422 study with the target substance CeTePox® 0214 H is available. Under the conditions of this study, CeTePox® 0214 H caused reduced body weight and body weight gain, reduced food consumption in parental male and female Han:WIST rats at 100 mg/kg bw/day administered by oral gavage. In male animals at 100 mg/kg bw/day, test item influence on hepatic function was detected in clinical chemistry parameters, in necropsy findings and histopathological findings (centrilobular vacuolation in the hepatocytes). At 100 mg/kg bw/day, the delivery data of dams (mean number of implantation sites and lower mean birth (total birth, live born and viable pups per litter) was slightly depressed. There were no test item related changes in male or female animals at 10 or 30 mg/kg bw/day. The development of the F1 offspring was not impaired at any dose level from birth to post-natal day 13 after repeated oral administration of dams. Based on these observations the NOAEL were determined as follows: NOAEL for systemic toxicity of male/female rats: 30 mg/kg bw/day, NOAEL for reproductive performance of male rats: 100 mg/kg bw/day, NOAEL for reproductive performance of female rats: 30 mg/kg bw/day, NOAEL for F1 Offspring: 100 mg/kg bw/day
The NOAEL for systemic toxicity of 30 mg/kg bw/day is used as PoD for DNEL derivation.
Step 1:PoD: NOAEL = 30 mg/kg bw/day
Step 2:Modification of PoD:
Standard respiratory volume, human (sRVhuman) for 8 hours: 6.7 m3
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m3/kg bw
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m3
Oral absorption of the rat/ inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50%/100 % (default)
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
Corrected NOAEC (inhalation) for workers:
= 30 mg/kg bw/day x 0.5 x 1/0.38 m3/kg bw/day x (6.7 m3/10 m3) x 1.4
= 37 mg/m3
Step 3: Overall AF= 75
Intraspecies AF (worker): 5
Interspecies AF, remaining differences: 2.5
Dose response relationship AF: 1
Exposure duration AF: 6
The exposure duration of the OECD TG 422 study performed with the test item was 50-67 days for females and 49 days for males.
Whole database AF: 1
The OECD TG 422 toxicity study was conducted according to regulatory standards and was adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
In conclusion,long term systemic inhalation DNEL, workers = 0.5 mg/m3
Acute, systemic DNEL- exposure via inhalation (workers)
No data on inhalation are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to mucosal tissue may occur by inhalative exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016).
For risk assessment it is assumed that the local effect (corrosion) is predominating over possible systemic effects. Since no threshold limit values can be defined, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Long term & acute, local DNEL- exposure via inhalation (workers)
No data on inhalation are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to mucosal tissue may occur by inhalative exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016). Since no threshold limit values can be defined, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Dermal
Long term, systemic DNEL- exposure via dermal route (workers)
No repeated dose dermal toxicity study with the target substance is available. Therefore, it will be necessary to obtain a long-term dermal DNEL by route-to-route extrapolation.
The NOAEL of 30 mg/kg bw/day derived from an OECD TG 422 study performed with the target was used as the PoD.
Step 1:PoD: NOAEL = 30 mg/kg bw/day
Step 2:Modification into a correct starting point:
Oral absorption of the rat/ dermal absorption of humans (ABS oral-rat / ABS derm-human): 100%/100 % (default)
Correction for difference between human and experimental exposure conditions: 7 d rat/5 d worker
Corrected NOAEL (dermal) for workers:
= 30 mg/kg bw/day x 1.4
= 42 mg/kg bw/day
Step 3:Overall AF= 300
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
Dose-response relationship AF: 1
Exposure duration AF: 6
In conclusion, long term systemic dermal DNEL, workers = 0.14 mg/kg bw/day
Acute, systemic DNEL- dermal exposure (workers)
No dermal experimental data are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to the skin may occur by dermal exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016).
Long term & acute, local DNEL- dermal exposure (workers)
No dermal experimental data are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to the skin may occur by dermal exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016). For risk assessment it is assumed that the local effect (corrosion) is predominating over possible systemic effects. Since no threshold limit values can be defined, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Hazard to the eye-local effects (worker)
The test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016). Since no threshold limit values can be defined for the local effect, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
References
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8:
Characterisation of dose [concentration]-response for human health. Version 2.1, November 2012
ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterisation, Version 3.0, May 2016
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Please refer to "Additional Information".
- 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:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- 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:
- medium hazard (no threshold derived)
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:
- 0.05 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Please refer to "Additional Information".
- 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:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- 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:
- medium hazard (no threshold derived)
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 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:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- 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:
- 2.5
- Justification:
- The default value for interspecies differences is used.
- 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:
- 0.15 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA, Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose-response for human health (Version: 2.1, November 2012).
Inhalation
Long term, systemic DNEL – exposure via inhalation (general population)
Using a conservative approach, a DNEL (long-term inhalation exposure) is calculated. This long-term DNEL is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).
No repeated dose inhalation toxicity study with CeTePox® 0214 H is available. Therefore, it will be necessary to obtain a long-term DNEL by route-to-route extrapolation:
An OECD TG 422 study with the target substance CeTePox® 0214 H is available. Under the conditions of this study, CeTePox® 0214 H caused reduced body weight and body weight gain, reduced food consumption in parental male and female Han:WIST rats at 100 mg/kg bw/day administered by oral gavage. In male animals at 100 mg/kg bw/day, test item influence on hepatic function was detected in clinical chemistry parameters, in necropsy findings and histopathological findings (centrilobular vacuolation in the hepatocytes). At 100 mg/kg bw/day, the delivery data of dams (mean number of implantation sites and lower mean birth (total birth, live born and viable pups per litter) was slightly depressed. There were no test item related changes in male or female animals at 10 or 30 mg/kg bw/day. The development of the F1 offspring was not impaired at any dose level from birth to post-natal day 13 after repeated oral administration of dams. Based on these observations the NOAEL were determined as follows: NOAEL for systemic toxicity of male/female rats: 30 mg/kg bw/day, NOAEL for reproductive performance of male rats: 100 mg/kg bw/day, NOAEL for reproductive performance of female rats: 30 mg/kg bw/day, NOAEL for F1 Offspring: 100 mg/kg bw/day
The NOAEL for systemic toxicity of 30 mg/kg bw/day is used as PoD for DNEL derivation.
Step 1: PoD: NOAEL = 30 mg/kg bw/day
Step 2: Modification of PoD:
Standard respiratory volume of the rat (sRVrat) for 24 hours: 1.15 m3/kg bw
Oral absorption of the rat/ inhalation absorption of humans (ABS oral-rat / ABS inh-human): 50%/100 % (default)
Corrected NOAEC (inhalation) for general population:
= 30 mg/kg bw/day x 0.5 x 1/1.15 m3/kg bw/day
= 13 mg/m3
Step 3: Overall AF= 150
Intraspecies AF (General population): 10
Interspecies AF, remaining differences: 2.5
Dose response relationship AF: 1
Exposure duration AF: 6
Whole database AF: 1
The OECD TG 422 toxicity study was conducted according to regulatory standards and was adequately reported. On this basis the quality of the database is not considered to contribute uncertainty and it is therefore not necessary to apply an additional factor.
In conclusion, long term systemic inhalation DNEL, general population = 0.08 mg/m3
Acute, systemic DNEL- exposure via inhalation (general population)
No data on inhalation are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to mucosal tissue may occur by inhalative exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016).
For risk assessment it is assumed that the local effect (corrosion) is predominating over possible systemic effects. Since no threshold limit values can be defined, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Long term, local DNEL- exposure via inhalation (general population)
No data on inhalation are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to mucosal tissue may occur by inhalative exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016). Since no threshold limit values can be defined, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Dermal
Long term, systemic DNEL- exposure via dermal route (general population)
No repeated dose dermal toxicity study with the target substance is available. Therefore, it will be necessary to obtain a long-term dermal DNEL by route-to-route extrapolation.
The NOAEL of 30 mg/kg bw/day derived from an OECD TG 422 study performed with the target was used as the PoD.
Step 1:PoD: NOAEL= 30 mg/kg bw/day
Oral absorption of the rat/dermal absorption of humans (ABS oral-rat / ABS derm-human): 100%/100 % (default)
Correction for difference between human and experimental exposure conditions: 7 d, 24 h rat/7 d, 24 h general population
Step 2:Overall AF= 600
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Dose-response relationship AF: 1
Exposure duration AF: 6
In conclusion, long term systemic dermal DNEL, general population = 0.05 mg/kg bw/day
Acute, systemic DNEL- dermal exposure (general population)
No dermal experimental data are available. However, the test substance is classified for skin corrosion (UN GHS Category 1B, H314) according to Regulation (EC) No 1272/2008 (CLP). This implies that a potential damage to the skin may occur by dermal exposure. Thus, the test substance is allocated to the moderate hazard band according to the ECHA guidance on IR/CSA, Part E (2016).
For risk assessment it is assumed that the local effect (corrosion) is predominating over possible systemic effects. Since no threshold limit values can be defined, a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Long term & acute, local DNEL- dermal exposure (general population)
The test item is classified for skin corrosion (UN GHS Category 1B) according to Regulation (EC) No 1272/2008 (CLP). According to the Guidance on IR + CSA, Part E (ECHA, 2016) the test substance is characterized with a moderate hazard. Since no threshold limit values can be defined for this kind of local effect, no DNEL derivation was performed. Instead a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
Oral
Long term, systemic DNEL- exposure by oral route (general population)
A NOAEL of 30 mg/kg bw/day for systemic toxicity derived from an OECD TG 422 study performed with the target was used as the PoD.
Step 1: PoD: NOAEL = 30 mg/kg bw/day
Step 2: Overall AF= 600
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Interspecies AF, remaining differences: Interspecies differences are fully covered by the allometric
scaling
Intraspecies AF (general population): 10
Dose-response relationship AF: 1
Exposure duration AF: 6.
In conclusion, long term systemic oral DNEL, general population= 0.05 mg/kg bw/day
Acute, systemic DNEL- exposure by oral route (general population)
Due to the acute oral toxicity observed for the test item, the substance is considered to be classified for acute oral toxicity Cat.4 under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776. In the ECHA Guidance it is stated that “[..], the acute DNEL can by default be set as 1-5 times the long-term DNEL”. Therefore, the DNEL for acute systemic oral, worker was extrapolated according to the ECHA Guidance by applying the AF of 0.33.
DNEL, long-term systemic dermal (0.05 mg/kg bw/day)/ AF (0.33)
DNEL, short-term systemic oral = 0.15 mg/kg bw/day
Hazard to the eye-local effects (general population)
The test item is classified for skin corrosion (UN GHS Category 1B) according to Regulation (EC) No 1272/2008 (CLP). Therefore, a hazard for the eyes cannot be excluded. According to the Guidance on IR + CSA, Part E (ECHA, 2016) the test substance is characterized with a moderate hazard. Since no threshold limit values can be defined for this kind of local effect, no DNEL derivation was performed. Instead a qualitative approach was applied to exposure and risk assessment with relevant RMMs (ECHA CSR R.8, 2012).
References
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8:
Characterization of dose [concentration]-response for human health. Version 2.1, November 2012
ECHA (2016). Guidance on information requirements and chemical safety assessment. Part E: Risk Characterization, Version 3.0, May 2016
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.
