Registration Dossier

Administrative data

Endpoint:
eye irritation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Data from reports from 1982 to 2011
Reliability:
1 (reliable without restriction)
Justification for type of information:
Octafluoropropane is a gas, making testing technically difficult. However, as the attached reports explains, it can be considered a saturated perfluorocarbon, a class of compounds with near identical toxicology properties.

We have several toxicity reports supporting our position; the details in this end point are taken from the first, which is also the most recent.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2011
Reference Type:
study report
Title:
Unnamed
Year:
2009
Reference Type:
study report
Title:
Unnamed
Year:
1989
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Principles of method if other than guideline:
SkinEthic exposed to subject material for 10 minutes. Viability of cells determined by their ability to reduce MTT. scored out of 100.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: volatile

Test animals / tissue source

Species:
other: SkinEthic

Test system

Vehicle:
unchanged (no vehicle)

Results and discussion

In vitro

Results
Irritation parameter:
other: Relativity viability
Value:
>= 93.2 - < 93.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on studies with other unsaturated perfluorocarbons, we can be confident octafluoropropane is not an eye irritant.
Executive summary:

Based on studies with other unsaturated perfluorocarbons, together with experience of its use as a device in eye surgury, we can be confident octafluoropropane is not an eye irritant.