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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test according to OECD 471 guideline, on Salmonella Typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 showed no genotoxicity with and without metabolic activation. In an vitro chromosome aberration test with CHO cells performed according to OECD 473 guideline, also no genotoxicity was seen with and without metabolic activation, while cytotoxicity was present. No additional reliable studies on genetic toxicity in vitro are available. Due to explosive properties of the substance, no further testing could be conducted.

Link to relevant study records

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Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
sister chromatid exchange assay in mammalian cells
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced
Test concentrations with justification for top dose:
dose range of 0, 160-2,500 pg/ml
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results:negative
Executive summary:

Effects observed in treated and untreated animals showed no relevant differences. In some cases presence of tumors in untreated animals was higher than in animals fed with this substance. Thus, the presence of tumors cannot be attributed to pentaerythritol tetranitrate.

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced
Test concentrations with justification for top dose:
doses up to 10 mg/plate
Vehicle / solvent:
No data
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Conclusions:
Interpretation of results:negative
Executive summary:

PETN was tested in four strains (S. typhimurium TA 1535, TA 1537, TA 98 and TA 100). Effects observed indicate that this substance does not influence in the presence of tumors.

Endpoint:
in vitro gene mutation study in mammalian cells
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
Pentaerythritol tetranitrate (PETN) is a highly explosive organic compound belonging to the same chemical family as nitroglycerin and nitrocellulose. PETN is a sensitive compound and is easily detonated by an appropriate mechanical shock or when it is exposed to heat. It retains its properties in storage for longer periods than do nitroglycerine and nitrocellulose. According to REACH annex XI, section, 2, testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible. This exemption (unstable substance) shall be applicable to PETN because it is “an unstable explosive” (as per CLP, hazard statement H200). Submitting the substance to testing would pose an extreme risk to the laboratory personnel and facilities due to explosive nature of the substance. Please find more information attached in IUCLID section 13.2.
Endpoint conclusion
Endpoint conclusion:
no study available

Genetic toxicity in vivo

Description of key information

No reliable data available, due to explosive properties of the substance, no further testing could be conducted.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

PETN is a sensitive compound and is easily detonated by an appropriate mechanical shock or when it is exposed to heat. Submitting the substance to testing would pose an extreme risk to the laboratory personnel and facilities due to explosive nature of the substance.

Justification for classification or non-classification

Reliable in vitro studies on pentaerythritol tetranitrate (Ames test and chromosome aberration) provide negative results in the presence and absence of metabolic activation. No further reliable data available.