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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-094-1 | CAS number: 25550-51-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No data were available for genotoxic activity of MHHPA, a read across using data from the structural analogue 4-MHHPA, that showed no genetic toxicity for MHHPA.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to IUCLID Section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to IUCLID Section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to IUCLID Section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
REACH Regulation 1907/2006, Annex VIII, Column 2, section 8.4 states that appropriate in vivo mutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data were available for genotoxic activity of MHHPA, instead, read across approach was applied using data from the structural analogue 4-MHHPA, as similar chemical and toxicological properties are assumed.
Ames-test:
A bacterial reverse mutation assay (Ames test) was performed according to OECD/EU test methods. Experiments were performed both in the absence and presence of metabolic activation at concentrations up to 5000 µg/plate. The substance did not induce reverse mutation in Salmonella typhimurium or Escherichia coli.
Chromosome aberration:
The ability to cause chromosomal damage was investigated in cultured human lymphocytes in vitroin the absence and presence of S9 metabolic activation according to OECD/EU test methods. Two independent experiments were performed. In the first experiment the cells were treated for 3 hours in presence and absence of S9 metabolism and harvested after 24 hours. This was corresponding to approximately 1.5 cell cycles. The second experiment was performed over the same time period with continuous exposure until harvest. 4-MHHPA did not induce chromosomal aberrations.
Cell gene mutation:
Gene mutation was investigated by assaying for 5-trifluorothymidine resistant mutants in mouse lymphoma L5178Y treated with 4-MHHPA, in absence and presence of S9 metabolic activation, using a fluctuation method. Methods used were in accordance with OECD/EU test guidelines. Two independent assays were performed. 4-MHHPA did not induce mutations at the TK locus of L5178Y mouse lymphoma cells.
In vivo-testing:
REACH Regulation 1907/2006, Annex VIII, Column 2, section 8.4 states that appropriatein vivomutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.
Justification for classification or non-classification
Based on the results obtained from genetic toxicity testing, MHHPA was not classified and labelled according to Regulation (EC) No 1272/2008 (CLP).
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.
