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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 238-289-2 | CAS number: 14338-82-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
According to the REACH Regulation, Annex XI.3 Substance-tailored exposure-driven testing: 3.1 Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.
3.2. (a) The manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled:
(i) the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI Section 3.5.
The results of the exposure assessment are described in the CSR chapter 9 and 10. No significant exposure in all scenarios of the manufacture and all identified uses were identified.
(ii) a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes;
Environment: Due to the identified uses, exposure to the environment can be excluded.
Human health: As a basis for exposure-based waiving, the TTC concept as devised by Munro et al. [1, 2] is applied. MBTester is predicted to fall within Cramer Class III (high hazard). Within Cramer class III, the 5th-percentile NOEL has been identified from chronic oral studies or other oral studies e.g., developmental toxicity, if they were more sensitive. The majority of NOELs were defined by studies in the rat.
The generic oral NOEL applicable to MBTester (Class III) is 0.15 mg/kg bw/day corresponding to a very low DNEL of 1.5 µg/kg bw/d.
(iii) the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposure are always well below the derived DNEL or PNEC.
The exposure of MBTester to humans or the environment can be considered as negligible and therefore below the derived DNEL or PNEC. Please refer to chapter 9 and 10 of the CSR.
Finally, the EU REACH Regulation clearly indicates the need for non-animal methods and provides the opportunity of waiving testing based on exposure considerations. The use of the TTC approach within REACH can be an appropriate tool in this context. With regard to human exposure, the TTC approach is only applicable in cases with detailed information on all anticipated uses and use scenarios.
In the case of the rubber additive MBTester all information on uses and use scenarios are collected and direct exposure of the substance to humans could only be identified for industrial workers. For industrial exposure scenarios, only the dermal route of exposure is of relevance in the context of risk assessment.
Chronic Effects
As a basis for exposure-based waiving, the TTC concept as developed by Munro et al. [1, 2] is applied:
MBTester is chemically well described and without indication of possible genotoxic effects. Therefore, the substance can be linked to the Cramer Class III (high hazard) as described in Munro et al., 1999. For Cramer Class III a human exposure threshold of 0.15 mg/kg bw/d (corresponding to 1.5μg/person/d) was proposed, using the 5th percentile value of distribution of NOELs for each class of chemicals, a body weight of 60 kg, and an assessment factor of 100 [1].
The oral DNEL for workers can therefore be directly derived without applying any assessment factors, because as mentioned above the assessment factors for intra- and interspecies variations are already implemented in the TTC concept of Munro. Thus, the oral DNEL corresponds to the TTC value of 1.5 µg/kg bw/day.
References
[1]Munro, IC, Ford, RA, Kennepohl, E, Sprenger, JG (1996).Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology 34, 829-867.
[2] Munro, IC, Kennepohl, E, Kroes, R (1999).A procedure for the safety evaluation of flavouring substances. Food and Chemical Toxicology 37, 207-232.
Short description of key information:
Sudies on fertility have not been performed, because no significant exposure occurs in all scenarios of manufacure and identified uses. In a worst case scenario a very conservative oral DNEL based on the TTC concept for chronic toxicity was chosen for MBTester, a Cramer class III substance (high hazard).
Justification for selection of Effect on fertility via oral route:
No further testing necessary based on exposure considerations (TTC concept and exposure-based waiving).
Justification for selection of Effect on fertility via inhalation route:
No further testing necessary based on exposure considerations (TTC concept and exposure-based waiving).
Justification for selection of Effect on fertility via dermal route:
No further testing necessary based on exposure considerations (TTC concept and exposure-based waiving).
Effects on developmental toxicity
Description of key information
Developmental toxicity testing has not been performed, because no significant exposure occurs in all scenarios of manufacure and identified uses. In a worst case scenario a very conservative oral DNEL based on the TTC concept for chronic toxicity was chosen for MBTester, a Cramer class III substance (high hazard).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
According to the REACH Regulation, Annex XI.3 Substance-tailored exposure-driven testing: 3.1 Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.
3.2. (a) The manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled:
(i) the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI Section 3.5.
The results of the exposure assessment are described in the CSR chapter 9 and 10. No significant exposure in all scenarios of the manufacture and all identified uses were identified.
(ii) a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes;
Environment: Due to the identified uses, exposure to the environment can be excluded.
Human health: As a basis for exposure-based waiving, the TTC concept as devised by Munro et al. [1, 2] is applied. MBTester is predicted to fall within Cramer Class III (high hazard). Within Cramer class III, the 5th-percentile NOEL has been identified from chronic oral studies or other oral studies e.g., developmental toxicity, if they were more sensitive. The majority of NOELs were defined by studies in the rat.
The generic oral NOEL applicable to MBTester (Class III) is 0.15 mg/kg bw/day corresponding to a very low DNEL of 1.5 µg/kg bw/d.
(iii) the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposure are always well below the derived DNEL or PNEC.
The exposure of MBTester to humans or the environment can be considered as negligible and therefore below the derived DNEL or PNEC. Please refer to chapter 9 and 10 of the CSR.
Finally, the EU REACH Regulation clearly indicates the need for non-animal methods and provides the opportunity of waiving testing based on exposure considerations. The use of the TTC approach within REACH can be an appropriate tool in this context. With regard to human exposure, the TTC approach is only applicable in cases with detailed information on all anticipated uses and use scenarios.
In the case of the rubber additive MBTester all information on uses and use scenarios are collected and direct exposure of the substance to humans could only be identified for industrial workers. For industrial exposure scenarios, only the dermal route of exposure is of relevance in the context of risk assessment.
Chronic Effects
As a basis for exposure-based waiving, the TTC concept as developed by Munro et al. [1, 2] is applied:
MBTester is chemically well described and without indication of possible genotoxic effects. Therefore, the substance can be linked to the Cramer Class III (high hazard) as described in Munro et al., 1999. For Cramer Class III a human exposure threshold of 0.15 mg/kg bw/d (corresponding to 1.5μg/person/d) was proposed, using the 5th percentile value of distribution of NOELs for each class of chemicals, a body weight of 60 kg, and an assessment factor of 100 [1].
The oral DNEL for workers can therefore be directly derived without applying any assessment factors, because as mentioned above the assessment factors for intra- and interspecies variations are already implemented in the TTC concept of Munro. Thus, the oral DNEL corresponds to the TTC value of 1.5 µg/kg bw/day.
References
[1]Munro, IC, Ford, RA, Kennepohl, E, Sprenger, JG (1996).Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology 34, 829-867.
[2] Munro, IC, Kennepohl, E, Kroes, R (1999).A procedure for the safety evaluation of flavouring substances. Food and Chemical Toxicology 37, 207-232.
Justification for selection of Effect on developmental toxicity: via oral route:
No further testing necessary based on exposure considerations (TTC concept and exposure-based waiving).
Justification for selection of Effect on developmental toxicity: via inhalation route:
No further testing necessary based on exposure considerations (TTC concept and exposure-based waiving).
Justification for selection of Effect on developmental toxicity: via dermal route:
No further testing necessary based on exposure considerations (TTC concept and exposure-based waiving).
Justification for classification or non-classification
No classification proposed. The potential routes of repeated exposure to humans can be considered as negligible.
Additional information
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.
