Registration Dossier
Registration Dossier
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EC number: 200-814-8 | CAS number: 74-84-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - workers
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (eg. C&L) has been identified and there is a potential for high peak exposures. This is not the case for Petroleum Gases. Dermal and oral studies are not technically feasible as they are gases at room temperature and all show very low toxicity via the inhalation route.
There was an absence of adverse effects relevant to humans in the repeat dose toxicity studies.
No chronic toxicity data are available for any Petroleum Gases, however, weight of evidence from subchronic tests (up to 90 days) and a consideration of their simple chemical structures, which have no reactive groups and carry no alerts for likely genotoxic carcinogenic activity from established Structure Activity Relationship analysis, together with the conclusion that Petroleum Gases are not genotoxic, provide a strong case for concluding that none will show any significant carcinogenic activity.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (eg. C&L) has been identified and there is a potential for high peak exposures. This is not the case for Petroleum Gases. Dermal and oral studies are not technically feasible as they are gases at room temperature and all show very low toxicity via the inhalation route.
There was an absence of adverse effects relevant to humans in the repeat dose toxicity studies.
No chronic toxicity data are available for any Petroleum Gases, however, weight of evidence from subchronic tests (up to 90 days) and a consideration of their simple chemical structures, which have no reactive groups and carry no alerts for likely genotoxic carcinogenic activity from established Structure Activity Relationship analysis, together with the conclusion that Petroleum Gases are not genotoxic, provide a strong case for concluding that none will show any significant carcinogenic activity.
A literature search was also performed for all LOA Category P (Petroleum Gases) monoconstituent substances (methane CAS 74-82-8, ethane CAS 74-84-0, propane CAS 74-98-6, butane CAS 106-97-8 and isobutane CAS 75-28-5) for literature published between January 1st2010 and 10thFebruary 2022 on PubMed database. Full list of relevant references and abstracts can be found below.
The majority of the results were case reports involving substance abuse or exposure to common household products. The test materials were not well defined and were often present as mixtures of multiple gases or other included products. Since no clear description of exposure compounds were included in these reports, it was not possible to attribute an outcome to any single compound. Furthermore, some reports described injuries from explosions or extreme cold temperatures caused by direct contact with these pressurized gases, which were caused by extreme temperatures and these injuries are already accounted for by personal protective equipment (PPE) in the hazard assessments. Lastly, multiple reports reported death due to asphyxiation, which is a result of oxygen depletion and not toxicological action of the substances to which the patients were exposed. There were reports of compound distribution in some tissues, however these were all done post mortem, with no clear indication of the time from exposure to death or analysis and therefore were considered not to be relevant for toxicological hazard and risk assessment purposes. Upon review, none of the publications were considered to be relevant to toxicology or risk assessment of the Category P monoconstituents and, therefore, were not included in the dossier. The authorship and abstracts from each identified publication are attached in section 13 for completeness.
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.
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