Registration Dossier
Registration Dossier
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EC number: 936-831-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.175 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Please refer to the Chapter "Additional information - worker".
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:
- 3.33 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Please refer to the Chapter "Additional information - worker".
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- 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
Identification of relevant dose descriptor:
For the derivation of the DNELs, the Reproductive/Developmental Screening Study (OECD 421) was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 100 mg/kg/day.
General information on toxicity:
The substance is not classified for acute toxicity. The LD50 value for the oral and dermal route is greater than 2000 mg/kg bw. It is neither irritant to skin nor eyes. It is not genotoxic in vitro.
The substance is classified as skin sensitizer in Cat. 1B / H317 according to Regulation (EC) No. 1272/2008.
In addition, a reproductive/developmental screening study in Wistar rats (ERBC, 2022) according to OECD 421 is available, which was performed at dose levels of 100, 300 and 1000 mg/kg bw/day. Effects on organ weights (increased liver weights in both sexes, increased thyroid weights in males) correlating with histopathological findings (hypertrophy) as well as effects concerning clinical pathology (increased TSH values in males) were observed in parental animals. The NOAEL for general, systemic toxicity was conservatively set at 100 mg/kg bw/d. The NOAEL for reproduction and development was set to 1000 mg/kg.
Therefore, the respective oral NOAEL of 100 mg/kg bw/day in the OECD 421 has been taken as conservative point of departure to derive the respective systemic DNELs.
Concerning local effects due to sensitization potential of the test substance, a qualitative risk assessment was performed for the worker. According to the Potency categorization suggested in Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), the test substance is assumed to be a moderate sensitizer. For workers, personal protective equipment is recommended to avoid any exposure to skin.
Route-to-route extrapolation:
On the basis of the low vapour pressure (<0.00001 Pa at 25°C), the exposure with the test substance via inhalation as a vapour is low. According to Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), it is proposed in the absence of route-specific information to include a default factor in the case of inhalation-to-oral extrapolation, assuming 50% oral and 100% inhalation absorption.
In addition, dermal absorption is usually assumed not to be higher than oral absorption. Therefore, according to Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), no default value is applied by performing oral-to-dermal extrapolation. Furthermore, as the test substance has a molecular weight of > 500 g/mol and the log Pow is > 4,5 a skin penetration of <10% can be assumed (ECHA GD chapter R7c, March 2020).
For the worker, the following DNELs were derived
For derivation of the long-term systemic inhalative DNEL for the test substance, the oral NOAEL of 100 mg/kg bw/d from the OECD 421 was taken as basis and converted into a corrected inhalative NOAEC of 88.16 mg/m3 for the worker.
Table 1. Long-term – inhalation, systemic effects
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NOAEL: 100 mg/kg bw/day |
|
Step 2) Modification of starting point | 50%/100%
0.38 m3/kg bw
6.7 m3/10 m3
| Ratio of oral (rat) to inhalation (human) absorption (default value, as proposed in the ECHA GD, R.8.4.2, Nov 2012
Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the ECHA GD, R.8.4.2, Nov 2012
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3) (ECHA GD, R.8.4.2, Nov 2012) |
Modified dose-descriptor | NOAEC corrected inhalative = 100 * (50/100) * (1/0.38) * (6.7/10) = 88.16 mg/m3 | |
Step 3) Assessment factors |
|
|
Allometric scaling | 1 | No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation according to ECHA GD, Chapter R8 (Nov, 2012) |
Remaining differences (interspecies) | 2.5 | According to ECHA GD, R.8.4.2, Nov 2012 |
Intraspecies | 5 | Standard factor for workers according to ECHA GD, R.8.4.2, Nov 2012 |
Exposure duration | 6 | according to ECHA GD, R.8.4.2, Nov 2012
Justification: the NOAEL of 100 mg/kg bw/day is based on effects seen in males, which were exposed to the test substance in the referring OECD 421 for 28 days. |
Dose response | 1 | according to ECHA GD, R.8.4.2, Nov 2012 |
Quality of database | 1 | according to ECHA GD, R.8.4.2, Nov 2012 (GLP and guideline compliant study) |
DNEL | Value | |
| 88.16 / (1 x 2.5 x 5 x 6 x 1 x 1) = 1.18 mg/m3 | |
For derivation of the long-term systemic dermal DNEL for the test substance, the oral NOAEL of 100 mg/kg bw/d from the OECD 421 was taken as basis. No route-to-route extrapolation is needed. However, as the test substance has a molecular weight of > 500 g/mol and the log Pow is > 4,5 a skin penetration of <10% can be assumed (ECHA GD chapter R7c, March 2020).
Table 2. Long-term – dermal, systemic effects
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NOAEL: 100 mg/kg bw/day |
|
Step 2) Modification of starting point | -
10% | Absorption (default value: 1)
Skin penetration according to ECHA GD chapter R7c, March 2020) |
Step 3) Assessment factors |
|
|
Allometric scaling | 4 | Assessment factor for allometric scaling according ECHA GD, R.8.4.2, Nov 2012 |
Remaining differences (interspecies) | 2.5 | Standard factor for remaining uncertainties according ECHA GD, R.8.4.2, Nov 2012 |
Intraspecies | 5 | Standard factor for workers according to ECHA GD, R.8.4.2, Nov 2012 |
Exposure duration | 6 | according to ECHA GD, R.8.4.2, Nov 2012
Justification: the NOAEL of 100 mg/kg bw/day is based on effects seen in males, which were exposed to the test substance in the referring OECD 421 for 28 days. |
Dose response | 1 | according to ECHA GD, R.8.4.2, Nov 2012 |
Quality of database | 1 | according to ECHA GD, R.8.4.2, Nov 2012 (GLP and guideline compliant study) |
DNEL | Value | |
| 100 x 10 / (4 x 2.5 x 5 x 6 x 1 x 1) = 3.33 mg/kg | |
According to ECHA Guidance on information requirements and CSR, chapter R8, a DNEL for acute systemic toxicity should be derived only if an acute systemic toxicity hazard leading to C&L has been identified. The test substance is not subject to classification and labelling and consequently the establishment of DNELs for acute/short-term exposure - systemic effects is not required.
The substance is not irritating to skin and eyes and therefore not classified according to Regulation 1272/2008/EC. No experimental data are available addressing local effects in the respiratory tract. Furthermore, the test substance is a skin sensitiser and hence subjected to classification as and Skin Sens. Cat 1B / H317 (May cause an allergic skin reaction) according to Regulation 1272/2008/EC Annex VI. The sensitizing reaction was chosen as most sensitive endpoint for local effects. A qualitative risk assessment was performed. According to the Potency categorization suggested in Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), the test substance is assumed to be a moderate sensitizer. For workers, personal protective equipment is recommended to avoid any exposure to skin.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.29 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Please refer to the Chapter "Additional information - general population".
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:
- 1.66 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):
- 6 000
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Please refer to the Chapter "Additional information - general population".
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- 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:
- 0.16 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Please refer to the Chapter "Additional information - general population".
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
Identification of relevant dose descriptor:
For the derivation of the DNELs, the Reproductive/Developmental Screening Study (OECD 421) was qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 100 mg/kg/day.
General information on toxicity:
The substance is not classified for acute toxicity. The LD50 value for the oral and dermal route is greater than 2000 mg/kg bw. It is neither irritant to skin nor eyes. It is not genotoxic in vitro.
The substance is classified as skin sensitizer in Cat. 1B / H317 according to Regulation (EC) No. 1272/2008.
In addition, a reproductive/developmental screening study in Wistar rats (ERBC, 2022) according to OECD 421 is available, which was performed at dose levels of 100, 300 and 1000 mg/kg bw/day. Effects on organ weights (increased liver weights in both sexes, increased thyroid weights in males) correlating with histopathological findings (hypertrophy) as well as effects concerning clinical pathology (increased TSH values in males) were observed in parental animals. The NOAEL for general, systemic toxicity was conservatively set at 100 mg/kg bw/d. The NOAEL for reproduction and development was set to 1000 mg/kg.
Therefore, the respective oral NOAEL of 100 mg/kg bw/day in the OECD 421 has been taken as conservative point of departure to derive the respective systemic DNELs.
The test substance is a skin sensitiser and hence subjected to classification as and Skin Sens. Cat 1B / H317 (May cause an allergic skin reaction) according to Regulation 1272/2008/EC Annex VI. The sensitizing reaction was chosen as most sensitive endpoint for local effects. According to the Potency categorization suggested in Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), the test substance is assumed to be a moderate sensitizer. As the test substance is contained in finished articles below the limits identified in Article 14(2) of REACH, in fact it is lower than 1% (ECHA GD chapter R7c, March 2020) no risk assessment has to be performed
Route-to-route extrapolation:
On the basis of the low vapour pressure (<0.00001 Pa at 25°C), the exposure with the test substance via inhalation as a vapour is low. According to Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), it is proposed in the absence of route-specific information to include a default factor in the case of inhalation-to-oral extrapolation, assuming 50% oral and 100% inhalation absorption.
In addition, dermal absorption is usually assumed not to be higher than oral absorption. Therefore, according to Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), no default value is applied by performing oral-to-dermal extrapolation. Furthermore, as the test substance has a molecular weight of > 500 g/mol and the log Pow is > 4,5 a skin penetration of <10% can be assumed (ECHA GD chapter R7c, March 2020).
For the general population, the following DNELs were derived
For derivation of the long-term systemic inhalative DNEL for the test substance, the oral NOAEL of 100 mg/kg bw/d from the OECD 421 was taken as basis and converted into a corrected inhalative NOAEC of 88.16 mg/m3 for the worker.
Table 3. Long-term – inhalation, systemic effects
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NOAEL: 100 mg/kg bw/day |
|
Step 2) Modification of starting point | 50%/100%
1.15 m3/kg bw
| Ratio of oral (rat) to inhalation (human) absorption (default value, as proposed in the ECHA GD, R.8.4.2, Nov 2012
Standard respiratory volume of a rat, corrected for 24 h exposure as proposed in the ECHA GD, R.8.4.2, Nov 2012 |
Modified dose-descriptor | NOAEC corrected inhalative = 100 * (50/100) * (1/1.15) * = 43.47 mg/m3 | |
Step 3) Assessment factors |
|
|
Allometric scaling | 1 | No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation according to ECHA GD, Chapter R8 (Nov, 2012) |
Remaining differences (interspecies) | 2.5 | According to ECHA GD, R.8.4.2, Nov 2012 |
Intraspecies | 10 | Standard factor for the general population according to ECHA GD, R.8.4.2, Nov 2012 |
Exposure duration | 6 | according to ECHA GD, R.8.4.2, Nov 2012
Justification: the NOAEL of 100 mg/kg bw/day is based on effects seen in males, which were exposed to the test substance in the referring OECD 421 for 28 days. |
Dose response | 1 | according to ECHA GD, R.8.4.2, Nov 2012 |
Quality of database | 1 | according to ECHA GD, R.8.4.2, Nov 2012 (GLP and guideline compliant study) |
DNEL | Value | |
| 43.47 / (1 x 2.5 x 10 x 6 x 1 x 1) = 0.29 mg/m3 | |
For derivation of the long-term systemic dermal DNEL for the test substance, the oral NOAEL of 100 mg/kg bw/d from the OECD 421 was taken as basis. No route-to-route extrapolation is needed. However, as the test substance has a molecular weight of > 500 g/mol and the log Pow is > 4,5 a skin penetration of <10% can be assumed (ECHA GD chapter R7c, March 2020).
Table 4. Long-term – dermal, systemic effects
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NOAEL: 100 mg/kg bw/day |
|
Step 2) Modification of starting point | -
10% | Absorption (default value: 1)
Skin penetration according to ECHA GD chapter R7c, March 2020) |
Step 3) Assessment factors |
|
|
Allometric scaling | 4 | Assessment factor for allometric scaling according ECHA GD, R.8.4.2, Nov 2012 |
Remaining differences (interspecies) | 2.5 | Standard factor for remaining uncertainties according ECHA GD, R.8.4.2, Nov 2012 |
Intraspecies | 10 | Standard factor for general population according to ECHA GD, R.8.4.2, Nov 2012 |
Exposure duration | 6 | according to ECHA GD, R.8.4.2, Nov 2012
Justification: the NOAEL of 100 mg/kg bw/day is based on effects seen in males, which were exposed to the test substance in the referring OECD 421 for 28 days. |
Dose response | 1 | according to ECHA GD, R.8.4.2, Nov 2012 |
Quality of database | 1 | according to ECHA GD, R.8.4.2, Nov 2012 (GLP and guideline compliant study) |
DNEL | Value | |
| 100 x 10 / (4 x 2.5 x 10 x 6 x 1 x 1) = 1.66 mg/kg | |
For derivation of the long-term systemic oral DNEL for the test substance, the oral NOAEL of 100 mg/kg bw/d from the OECD 421 was used as starting point.
Table 5. Long-term – oral, systemic effects
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NOAEL: 100 mg/kg bw/day |
|
Step 2) Modification of starting point | -
| |
Step 3) Assessment factors |
|
|
Allometric scaling | 4 | Assessment factor for allometric scaling according to ECHA GD, Chapter R8 (Nov, 2012) |
Remaining differences (interspecies) | 2.5 | According to ECHA GD, R.8.4.2, Nov 2012 |
Intraspecies | 10 | Standard factor for the general population according to ECHA GD, R.8.4.2, Nov 2012 |
Exposure duration | 6 | according to ECHA GD, R.8.4.2, Nov 2012
Justification: the NOAEL of 100 mg/kg bw/day is based on effects seen in males, which were exposed to the test substance in the referring OECD 421 for 28 days. |
Dose response | 1 | according to ECHA GD, R.8.4.2, Nov 2012 |
Quality of database | 1 | according to ECHA GD, R.8.4.2, Nov 2012 (GLP and guideline compliant study) |
DNEL | Value | |
| 100 / (4 x 2.5 x 10 x 6 x 1 x 1) = 0.16 mg/kg | |
According to ECHA Guidance on information requirements and CSR, chapter R8, a DNEL for acute systemic toxicity should be derived only if an acute systemic toxicity hazard leading to C&L has been identified. The test substance is not subject to classification and labelling and consequently the establishment of DNELs for acute/short-term exposure - systemic effects is not required.
The substance is not irritating to skin and eyes and therefore not classified according to Regulation 1272/2008/EC. No experimental data are available addressing local effects in the respiratory tract. Furthermore, the test substance is a skin sensitiser and hence subjected to classification as and Skin Sens. Cat 1B / H317 (May cause an allergic skin reaction) according to Regulation 1272/2008/EC Annex VI. The sensitizing reaction was chosen as most sensitive endpoint for local effects. According to the Potency categorization suggested in Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), the test substance is assumed to be a moderate sensitizer. As the test substance is contained in finished articles below the limits identified in Article 14(2) of REACH, in fact it is lower than 1% (ECHA GD chapter R7c, March 2020) no risk assessment has to be performed
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