Registration Dossier

Administrative data

Description of key information

Members of Petroleum Gases category are flammable gases at room temperature.  Therefore, in accordance with section 2 of REACH Annex XI, neither skin nor eye irritation studies need be conducted. There are no indications that main constituents of the Petroleum Gases are skin or eye irritants. Direct skin or mucous membrane contact with liquid forms of C1- C4 alkane gases may cause burns and frostbite due to the extreme cold of the liquid. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In accordance with Section 2 of REACH Annex XI, studies on skin and eye irritation do not need to be conducted as members of the Petroleum Gases category are flammable gases at room temperature.

Category members are not expected to be irritating and this is confirmed by pre-guideline rabbit skin and eye irritation studies on formulations although these data cannot be relied upon since there are insufficient details on how the test materials (as gases) were applied (Anon, 1982. Final report of the safety assessment of isobutane, isopentane, n-butane and propane, J American College of Toxicology, Volume 1, Number 4, 127-142).

 

Skin

Non-human information

No guideline studies available.

 

Human information

Very slight and transient erythema occurred randomly among the subjects following repeated applications of aerosol products, containing a mixture of isobutane and propane at 64.5% and 70% by weight, respectively. The reactions were reported to be negligible. Both isobutane and propane were considered practically non irritant to human skin (Anon 1982).

Direct skin contact with liquid forms of C1- C4 alkane gases may cause burns and frostbite due to the extreme cold of the liquid (rapid evaporation lowers the skin temperature causing frost injuries) (Cavender 1994).

 

Eye

Non-human information

No guideline studies available.

 

Human information

Direct mucous membrane contact with liquid forms of C1- C4 alkane gases may cause burns and frostbite due to the extreme cold of the liquid (Cavender 1994).

 

Respiratory tract

Non-human information

No data exist for the C1-C4 alkanes. There are no indications of irritation from repeat dose inhalation studies.

 

Human information

Berzins et al (1995) reported human exposure to propane at 100000 ppm (180 mg/L) caused slight dizziness but no mucosal irritation of nose, eyes or respiratory tract was observed.

Justification for classification or non-classification

There is no evidence that members of this category are irritating. 

 

These findings do not warrant classification for skin, eye, or respiratory tract irritancy under DSD or CLP.