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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
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.

Data source

Materials and methods

Test animals


Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion