Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Data source

Reference
Reference Type:
other: Read across from other internal studies
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Read across from category members
Principles of method if other than guideline:
Trend analysis from category members show that members are practically nontoxic by inhalation. Slope of trend line equals zero.
GLP compliance:
not specified
Test type:
other: Read across from in vivo data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Perfluorohexanes, CAS# 1064697-81-9
Perfluoroheptanes, CAS# 1064698-16-3
Perfluorotributylamines, CAS# 1064698-37-8
Perfluorotripropylamines, CAS# 338-83-0
Perfluoro-N-methylmorpholine, CAS# 382-28-5
Perfluoro-N-C1,3-alkyl morpholines, CAS# 1093615-61-2
Perfluoro-C6,8-furans, pyrans and acyclic ethers , CAS# 1064698-52-7

Test animals

Species:
other: Rats, Guinea Pigs, Mice
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 17 mg/L air
Exp. duration:
4 h
Remarks on result:
other: No mortality was seen in any test animals. No untoward clinical signs were observed as a result of exposure to category members. Taking into account the MW of PMM, the calculated LC50 is > 7.58 mg/l.
Mortality:
No mortality observed.
Clinical signs:
other: No untoward clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
No mortality or untoward reactions were seen in test animals after a 4 hour exposure to category members.
Executive summary:

An acute inhalation toxicity was performed on category members. Rats, guinea pigs, and mice were exposed to the category members in exposure chambers for a set period of time. Upon removal from the chamber several animals were sacrificed to observe sections of their lungs, spleen, liver and kidneys. The remaining animals were observed for 2 weeks, weighed, sacrificed and grossly examined. There were no deaths in the study. Weight gains were normal and at necropsy no grossly observable lesions were noted. Based on these results, the category members can be considered practically non-toxic by inhalation.

Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members. The readacross is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.