Registration Dossier

Administrative data

Description of key information

No reliable data available, due to explosive properties of the substance, no further testing could be conducted. Nevertheless, cutaneous sensitivity to PETN has been reported in humans and appears to be a common effect of exposure to all organic nitrates.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation, other
Type of information:
other: Collection of data
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
GLP compliance:
not specified
Interpretation of results:
study cannot be used for classification
Executive summary:

Patch tests in 20 persons gave no evidence of sensitization, although some cases of mild illness and dermatitis have been attributed to contact with the substance in ordnance plants.

Endpoint:
skin sensitisation: in vitro
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:
skin sensitisation, other
Type of information:
other: Collection of data
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Interpretation of results:
study cannot be used for classification
Executive summary:

McConnell et al (1946) reviewed the industrial hygiene and the incidence of occupational dinisease in government-owned ordnance plants in the United States during World War II. An apparent increase in the number of sudden deaths among explosives workers was observed, but in 915,000 man-years of exposure to the various organic nitrates, no fatalities were attributed to the aliphatic nitrates. An undetermined number of episodes of mild illness or dermatitis were attributed to exposure to PETN. Workers involved in the production of nitroglycerin and other organic nitrates that are readily absorbed through the skin suffered at times from a syndrome called "dynamite head" or "powder headache", which was manifested as severe headache, dizziness, and postural weakness upon initial exposure (Gilman et al., 1985). These symptoms diminished with time but then often reappeared at the beginning of the work week. The initial symptoms reflected the vasodilator action of the nitrates, and the so-called "Monday disease" was attributed to tolerance to this action developed during the work week and to expression of an organic nitrate dependence that became apparent after a several-day break in exposure. The risk of developing this condition while working with PETN is not considered to be high because of the relatively poor dermal absorption of the chemical and because it is usually processed as a wet slurry or precipitate (Dept. of the Army, 1967).

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.

Respiratory sensitisation

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

No reliable data available.