Registration Dossier
Registration Dossier
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EC number: 500-537-5 | CAS number: 161075-00-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro studies conducted on an analogue substance are reported. The
studies showed negative results in the bacterial reverse mutation assay
in 5 strains, with and without metabolic activation (OECD TG 471) up to
the maximum recommended dose, and in a chromosomal aberration study in
human lymphocytes, with and without metabolic activation (OECD TG 473).
Basing on the analogue approach, no genotoxic activity is expected for
GALDEN LMW.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH: see RAAF document attached
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Results were obtained on an analogue substance.
- Conclusions:
- The source substance used for the read across did not show any mutagenic activity in 4 bacterial strains of Salmonella typhimurium and 1 strain of Escherichia coli, when treated at up to the highest recommended dose, both with and without metabolic activation in two independent experiments.
Therefore, based on the analogue approach, considering the similarities of structure, molecular weight and toxicological profile as discussed in the read-across justification document, GALDEN LMW is not expected to display potential mutagenic activity in the Bacterial Reverse Mutation Test. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH: see RAAF document attached
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- lymphocytes: from human donors
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Results were obtained on an analogue substance.
- Conclusions:
- The resuts of chromosomal aberration with an analoguous perfluoropolyether substance showed no significant chromosomal damages in human lymphocytes up to the concentration of 5000 µg/ml both in the absence and in the presence of metabolic activation, in two independent experiments.
Based on the analogue approach, considering the similarities of structure, molecular weight and toxicological profile, GALDEN LMW is expected to show no clastogenic effects under similar test conditions.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In the absence of in vivo studies with Galden LMW, a read across
approach was used. No increase in micronucleated cells were observed in
the bone marrow of rats exposed by inhalation to a close analogue
substance.
The structure/composition and molecular weight of the analogue substance
are considered sufficiently close to justify the read-across. No
genotoxic activity is expected for GALDEN LMW.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH: see RAAF document attached
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Remarks:
- (clean air)
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Results were obtained on an analogue substance.
- Conclusions:
- No significant increase in the frequency of micronucleated cells were observed in the bone marrow of males and female rats exposed during a single continuous 6-hour inhalation exposure at up to 20 000 ppm (2.0 % v/v) of an analogue substance.
Based on the analogue approach, considering the similarities of structure, molecular weight and toxicological profile, GALDEN LMW is expected to show no mutagenic effects under similar test conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The read-across approach using an analogue substance with a combination of slightly different structures and with a close range of molecular weight was applied in order to derive a conclusion for the potential genotoxic activity of GALDEN LMW.
GALDEN is a Perfluoropolyethers (PFPE) with low reactivity and limited water solubility. Because of the presence of terminal hydrogens and greater water solubility the analogue used for the read-across is expected to present a higher reactivity and constitute a worse case for assessing genotoxicity potential of GALDEN LMW.
All the fully fluorinated PFPE fluids possess the physico-chemical properties which are typical of perfluorinated materials and furthermore the available experimental data on GALDEN LMW and HFPE analogue H GALDEN show that the two substances have close profile regarding physico-chemical properties, acute toxicity, skin and eye irritation and skin sensitization. The presence of hydrogenated end-group on the analog is expected to increase reactivity and thus provides a worse case to anticipate properties of GALDEN LMW.
Basing on the analogue approach GALDEN LMW is expected to have no genotoxic activity.
The following in vitro and in vivo studies conducted under GLP on a HFPE analogue of similar molecular weight range are reported:
OECD 471 (Bacterial Reverse Mutation Assay)
OECD 473 (In vitro Mammalian Chromosome Aberration Test)
OECD 474 (In vivo Mammalian Erythrocyte Micronucleus Test)
Based on the absence of genotoxic activities with the analogue substance, and read-across approach GALDEN LMW is not expected to have genotoxic activity.
Justification for classification or non-classification
Basing on the reported experimental results on a structural analogue GALDEN LMW is not expected to have genotoxic activity.
Therefore, according to Regulation (EC) 1272/2008, GALDEN LMW does not need to be classified for the hazard class “Germ cell mutagenicity”.
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