Registration Dossier
Registration Dossier
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EC number: 939-056-4 | CAS number: 1469982-95-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 172.85 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10.2
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.15 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
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:
- 24.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- Overall assessment factor (AF):
- 40.8
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.7 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
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
Worker:
Based on the available data, “Reaction product of urea, formaldehyde, glyoxal and diethylene glycol” (Fixapret PC, vor Magnesiumchlorid-Zugabe) has to be labeled with R48/22 – STOT RE Cat.2 based on the content of Diethylene glycol (DEG, CAS # 111-46-6) above 10 % but below 20 %. DEG causes kidney damage in humans. The German BfR assessed the potential hazard of DEG in toothpaste (Statement No. 025/2008, 16th of July 2007) and stated that humans are about 10-20 times more sensitive than rats and that the first functional and morphological kidney effects are seen at a dose level of 50-100 mg/kg bw in humans. It is stated in this document, that the daily human intake of DEG should be below 0.5 -1.0 mg/kg bw. More details can be found at http://www.bfr.bund.de/de/a-z_index/diethylenglykol__deg_-23059.html
Depending on the formaldehyde content, a labeling with R 43/Skin Sens Cat.1 and/or Cancer Cat. 1B/R45 may also apply.
The DNELs are derived based on the available data for Fixapret PC with additional correction of the DNEL based on DEG content, if deemed necessary. A correction of the long-term DNELs due to the formaldehyde content of less than 1 % is not deemed necessary as the respective formaldehyde DNELs (see formaldehyde dossier on the ECHA website) multiplied by 100 (100 % to 1 %) are higher than the DNELs derived for Fixapret PC.
The primary routes of anticipated industrial and professional exposure for “Reaction product of urea, formaldehyde, glyoxal and diethylene glycol” (Fixapret PC, vor Magnesiumchlorid-Zugabe), are via inhalation and skin contact. In industrial settings, ingestion is not an anticipated route of exposure, but has to be considered for the general population (see below).
Inhalation long-term exposure – systemic effects:
The NOAEL from an oral OECD Guideline 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) (BASF SE, 2013) was identified as the appropriate starting point for DNEL derivation for long-term exposure following inhalation. The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for rats.
This point of departure was modified to get the corrected starting point for DNEL derivation. As a first step, route-to-route extrapolation was performed as recommended in the "Guidance on information requirements and chemical safety assessment, Chapter R.8, p. 26 f.:
The oral rat NOAEL was converted into the inhalative human NOAEC corrected for differences between the 8-hour standard inhalation volume of rats versus humans, and for differences between the 8-hour inhalation volume of workers in rest versus workers in light activity, by multiplying with the corresponding factors (x 1/0.38 m³/kg/d x 6.7 m³/10 m³). The resulting corrected starting point for inhalation DNEL derivation for workers is equal to 1763.15 mg/m³.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 1
Besides the applied allometric scaling factors no additional interspecies factor for remaining differences has been used based on the fact that concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat's ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and humans have to be taken into account. Within the ERASM project, studies in rats and mice are being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a standard procedure (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006).
- Intraspecies factor: 3
There were no systemic effects observed in the repeated dose study with rats. Therefore an intraspecies factor of 3 is considered to be sufficient.
- Exposure duration: 3.4 (Batke et.al., 2011)
Within the ERASM project, time-extrapolation factors were evaluated with the database RepDoseg that currently contains about 670 substances and 2200 studies on repeated-dose toxicity. It has been shown that as long as the material is soluble, the sub-acute to sub-chronic factor was 1.5, rather than 3 , the sub-acute to chronic factor was 3.4 and the sub-chronic to chronic factor was 1.4 (Batke et al, 2011). Furthermore, female rats were exposed for up to 50 days instead of 28 days as requested in a regular 28-day study.
- Dose-response: 1
Total AF = 1 x 3 x 3.4 x 1 = 10.2
Based on this calculation the resulting DNEL is 172.85 mg/m³.
As stated above, the DEG content of Fixapret PC is above 10 % but below 20 %. For DEG, a inhalation long-term DNEL for the worker of 60 mg/m³ was derived (see dossier of DEG, CAS # 111-46-6). As the DEG-content in Fixapret PC is below 20 %, the maximum DEG content in Fixapret PC is 34.57 mg/m³, if the DNEL for Fixapret PC is not exceeded. As this value is below 60 mg/m³, no further correction of this DNEL is needed. The long-term inhalation DNEL for Fixapret PC of 172.85 mg/m³ is therefore also protecting for any hazards that might stem from the DEG exposure within Fixapret PC.
Dermal long-term exposure – local effects:
Dermal long-term exposure – systemic effects:
The NOAEL from an oral OECD Guideline 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) (BASF SE, 2013) was identified as the appropriate starting point for DNEL derivation for long-term dermal exposure. The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for rats.
There is no data available indicating that dermal uptake is considerably lower than oral uptake. The oral systemic long-term NOAEL was therefore considered appropriate for derivation of a dermal systemic long-term DNEL without further correction.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 4
Recommended for the rat in REACh Guidance document R.8 for allometric scaling
- Intraspecies factor: 3
There were no systemic effects observed in the repeated dose study with rats. Therefore an intraspecies factor of 3 is considered to be sufficient.
- Exposure duration: 3.4 (Batke et.al., 2011)
Within the ERASM project, time-extrapolation factors were evaluated with the database RepDoseg, that currently contains about 670 substances and 2200 studies on repeated-dose toxicity. It has been shown that as long as the material is soluble, the sub-acute to sub-chronic factor was 1.5, rather than 3 , the sub-acute to chronic factor was 3.4 and the sub-chronic to chronic factor was 1.4 (Batke et al, 2011). Furthermore, female rats were exposed for up to 50 days instead of 28 days as requested in a regular 28-day study.
- Dose-response: 1
- Remaining differences: 1 (Escher and Mangelsdorf, 2009; Batke et al, 2010; Bitsch et al, 2006).
Within the ERASM project, studies in rats and mice are being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a standard procedure (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006).
Total AF = 4 x 3 x 3.4 x 1 x 1 = 40.8
Based on this calculation the resulting DNEL is 24.5 mg/kg bw/day.
As stated above, the DEG content of Fixapret PC is above 10 % but below 20 %. For DEG, a dermal long-term DNEL for the worker of 106 mg/kg bw/day was derived (see dossier of DEG, CAS # 111-46-6). As the DEG-content in Fixapret PC is below 20 %, the maximum DEG content in Fixapret PC is 4.9 mg/kg bw/day, if the DNEL for Fixapret PC is not exceeded. As this value is below 106 mg/kg bw/day, no further correction of this DNEL is needed. The dermal long-term DNEL for Fixapret PC of 24.5 mg/kg bw/day is therefore also protecting for any hazards that might stem from the DEG exposure within Fixapret PC.
- Batke M, Escher S, Hoffmann-Doerr S, Melber C, Messinger H, Mangelsdorf I.(2011).Evaluation of time extrapolation factors based on the database RepDose. Toxicology Letters 205 (2011) 122– 129.
- Escher S and Mangelsdorf I. (2009). Evaluation of risk assessment factors for inter-species and time-extrapolation. Toxicol Lett 189:S247-S248. 46th Congress of the European Societies of Toxicology, 13-16 September 2009, Dresden.
- Bitsch A, Jacobi S, Melber C, Wahnschaffe U, Simetska N, Mangelsdorf I. (2006).REPDOSE: A database on repeated dose toxicity studies of commercial chemicals – a multifunctional tool. Regul Toxicol Pharmacol 46:202-210.
-ECHA (2008). REACh Guidance document R.8
-ECETOC (2003). Derivation of Assessment factors for Human Health Risk Assessment. Technical Report No. 86, February 2003.
-ECETOC (2010). Guidance on Assessment Factors to Derive DNELs.Technical Report No. 110, October 2010.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 51.15 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 17
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.56 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
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:
- 14.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 68
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
- Justification:
- see discussion
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
Consumer
Based on the available data, “Reaction product of urea, formaldehyde, glyoxal and diethylene glycol” (Fixapret PC, vor Magnesiumchlorid-Zugabe) has to be labeled with R48/22 – STOT RE Cat.2 based on the content of Diethylene glycol (DEG, CAS # 111-46-6) above 10 % but below 20 %. DEG causes kidney damage in humans. The German BfR assessed the potential hazard of DEG in toothpaste (Statement No. 025/2008, 16th of July 2007) and stated that humans are about 10-20 times more sensitive than rats and that the first functional and morphological kidney effects are seen at a dose level of 50-100 mg/kg bw in humans. It is stated in this document, that the daily human intake of DEG should be below 0.5 -1.0 mg/kg bw. More details can be found at http://www.bfr.bund.de/de/a-z_index/diethylenglykol__deg_-23059.html
Depending on the formaldehyde content, a labeling with R 43/Skin Sens Cat.1 and/or Cancer Cat. 1B/R45 may also apply.
The DNELs are derived based on the available data for Fixapret PC with additional correction of the DNEL based on DEG content, if deemed necessary. A correction of the long-term DNELs due to the formaldehyde content of less than 1 % is not deemed necessary as the respective formaldehyde DNELs (see formaldehyde dossier on the ECHA website) multiplied by 100 (100 % to 1 %) are higher than the DNELs derived for Fixapret PC.
For the general population, all three possible routes of exposure (oral, dermal, inhalation) have to be taken into account.
Inhalation long-term exposure – systemic effects:
The NOAEL from an oral OECD Guideline 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) (BASF SE, 2013) was identified as the appropriate starting point for DNEL derivation for long-term exposure following inhalation. The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for rats.
This point of departure was modified to get the correct starting point for DNEL derivation. As a first step, route-to-route extrapolation was performed as recommended in the "Guidance on information requirements and chemical safety assessment, Chapter R.8, p. 26 f.:
The oral rat NOAEL was converted into the inhalative human NOAEC corrected for differences between the 24-hour standard inhalation volume of rats versus humans by multiplying with the corresponding factor (x 1/1.15 m³/kg/d). The resulting corrected starting point for inhalation DNEL derivation for the general population is equal to 869.56 mg/m³.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 1
Besides the applied allometric scaling factors no additional interspecies factor for remaining differences has been used based on the fact that concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat's ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and humans have to be taken into account. Within the ERASM project, studies in rats and mice are being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a standard procedure (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006).
- Intraspecies factor: 5
There were no systemic effects observed in the repeated dose study with rats. Therefore an intraspecies factor of 5 is considered to be sufficient.
- Exposure duration: 3.4 (Batke et.al., 2011)
Within the ERASM project, time-extrapolation factors were evaluated with the database RepDoseg that currently contains about 670 substances and 2200 studies on repeated-dose toxicity. It has been shown that as long as the material is soluble, the sub-acute to sub-chronic factor was 1.5, rather than 3 , the sub-acute to chronic factor was 3.4 and the sub-chronic to chronic factor was 1.4 (Batke et al, 2011). Furthermore, female rats were exposed for up to 50 days instead of 28 days as requested in a regular 28-day study.
- Dose-response: 1
Total AF = 1 x 5 x 3.4 x 1 = 17
Based on this calculation the resulting DNEL is 51.15 mg/m³.
As stated above, the DEG content of Fixapret PC is above 10 % but below 20 %. For DEG, a inhalation long-term DNEL for the consumer of 12 mg/m³ was derived (see dossier of DEG, CAS # 111-46-6). As the DEG-content in Fixapret PC is below 20 %, the maximum DEG content in Fixapret PC is 10.23 mg/m³, if the DNEL for Fixapret PC is not exceeded. As this value is below 12 mg/m³, no further correction of this DNEL is needed. The long-term inhalation DNEL for Fixapret PC of 51.15 mg/m³ is therefore also protecting for any hazards that might stem from the DEG exposure within Fixapret PC.
Dermal long-term exposure – local effects:
Dermal long-term exposure – systemic effects:
The NOAEL from an oral OECD Guideline 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) (BASF SE, 2013) was identified as the appropriate starting point for DNEL derivation for long-term dermal exposure. The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for rats.
There is no data available indicating that dermal uptake is considerably lower than oral uptake. The oral systemic long-term NOAEL was therefore considered appropriate for derivation of a dermal systemic long-term DNEL without further correction.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 4
Recommended for the rat in REACh Guidance document R.8 for allometric scaling
- Intraspecies factor: 5
There were no systemic effects observed in the repeated dose study with rats. Therefore an intraspecies factor of 5 is considered to be sufficient.
- Exposure duration: 3.4 (Batke et.al., 2011)
Within the ERASM project, time-extrapolation factors were evaluated with the database RepDoseg that currently contains about 670 substances and 2200 studies on repeated-dose toxicity. It has been shown that as long as the material is soluble, the sub-acute to sub-chronic factor was 1.5, rather than 3 , the sub-acute to chronic factor was 3.4 and the sub-chronic to chronic factor was 1.4 (Batke et al, 2011). Furthermore, female rats were exposed for up to 50 days instead of 28 days as requested in a regular 28-day study.
- Dose-response: 1
- Remaining differences: 1 (Escher and Mangelsdorf, 2009; Batke et al, 2010; Bitsch et al, 2006).
Within the ERASM project, studies in rats and mice are being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a standard procedure (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006).
Total AF = 4 x 5 x 3.4 x 1 x 1 = 68
Based on this calculation the resulting DNEL is 14.7 mg/kg bw/day.
As stated above, the DEG content of Fixapret PC is above 10 % but below 20 %. For DEG, a dermal long-term DNEL for the consumer of 53 mg/kg bw/day was derived (see dossier of DEG, CAS # 111-46-6). As the DEG-content in Fixapret PC is below 20 %, the maximum DEG content in Fixapret PC is 2.94 mg/kg bw/day, if the DNEL for Fixapret PC is not exceeded. As this value is below 56 mg/kg bw/day, no further correction of this DNEL is needed. The dermal long-term DNEL for Fixapret PC of 14.7 mg/kg bw/day is therefore also protecting for any hazards that might stem from the DEG exposure within Fixapret PC.
Oral long-term exposure – systemic effects:
The NOAEL from an oral OECD Guideline 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) (BASF SE, 2013) was identified as the appropriate starting point for DNEL derivation for long-term oral exposure. The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg bw/d for rats.
The NOAEL of 1000 mg/kg bw/day was considered appropriate as point of departure for DNEL derivation.
For DNEL derivation, the following assessment factors (AF) were applied to the corrected starting point:
- Interspecies factor: 4
Recommended for the rat in REACh Guidance document R.8 for allometric scaling
- Intraspecies factor: 5
There were no systemic effects observed in the repeated dose study with rats. Therefore an intraspecies factor of 5 is considered to be sufficient.
- Exposure duration: 3.4 (Batke et.al., 2011)
Within the ERASM project, time-extrapolation factors were evaluated with the database RepDoseg that currently contains about 670 substances and 2200 studies on repeated-dose toxicity. It has been shown that as long as the material is soluble, the sub-acute to sub-chronic factor was 1.5, rather than 3 , the sub-acute to chronic factor was 3.4 and the sub-chronic to chronic factor was 1.4 (Batke et al, 2011). Furthermore, female rats were exposed for up to 50 days instead of 28 days as requested in a regular 28-day study.
- Dose-response: 1
- Remaining differences: 1 (Escher and Mangelsdorf, 2009; Batke et al, 2010; Bitsch et al, 2006).
Within the ERASM project, studies in rats and mice are being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a standard procedure (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006).
Total AF = 4 x 5 x 3.4 x 1 x 1 = 68
As a consequence, the resulting DNEL for long-term oral local and systemic effects is 14.7 mg/kg bw/d for the general population.
Due to the DEG content of Fixapret PC, this DNEL needs to be further corrected down to 2.5 mg/kg bw/d:
The German BfR assessed the potential hazard of DEG in toothpaste (Statement No. 025/2008, 16th of July 2007) and stated that humans are about 10-20 times more sensitive than rats and that the first functional and morphological kidney effects for DEG are seen at a dose level of 50-100 mg/kg bw in humans. It is stated in this document, that the daily human intake of DEG should be below 0.5 -1.0 mg/kg bw. More details can be found at http://www.bfr.bund.de/de/a-z_index/diethylenglykol__deg_-23059.html
As stated above, the DEG content of Fixapret PC is above 10 % but below 20 %. As the maximum daily oral intake of DEG should not exceed 0.5 mg/kg bw/day and based on a maximum DEG content below 20 %, a consumer oral-long term DNEL of 2.5 mg/kg is proposed for Fixapret PC.
- Batke M, Escher S, Hoffmann-Doerr S, Melber C, Messinger H, Mangelsdorf I.(2011).Evaluation of time extrapolation factors based on the database RepDose. Toxicology Letters 205 (2011) 122– 129.
- Escher S and Mangelsdorf I. (2009). Evaluation of risk assessment factors for inter-species and time-extrapolation. Toxicol Lett 189:S247-S248. 46th Congress of the European Societies of Toxicology, 13-16 September 2009, Dresden.
- Bitsch A, Jacobi S, Melber C, Wahnschaffe U, Simetska N, Mangelsdorf I. (2006).REPDOSE: A database on repeated dose toxicity studies of commercial chemicals – a multifunctional tool. Regul Toxicol Pharmacol 46:202-210.
-ECHA (2008). REACh Guidance document R.8
-ECETOC (2003). Derivation of Assessment factors for Human Health Risk Assessment. Technical Report No. 86, February 2003.
-ECETOC (2010). Guidance on Assessment Factors to Derive DNELs.Technical Report No. 110, October 2010.
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.
