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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

HQEE was considered to be non-mutagenic to bacteria and to mouse lymphoma cells in vitro.

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Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 from the livers of male Fischer rats induced with Arochlor 1254
Test concentrations with justification for top dose:
17, 50, 167, 500, 1667 and 5000 ug/plate
Vehicle / solvent:
DMSO
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-aminoanthracene
Details on test system and experimental conditions:
The study used both plate incorporation and pre-incubation protocols.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and 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
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
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
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information): negative

HQEE was considered to be non-mutagenic to bacteria in vitro.
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 from Aroclor 1254 induced rats
Test concentrations with justification for top dose:
0, 1000, 1250, 1500, 1750, 1984 µg/mL.
Vehicle / solvent:
Sterile distilled water
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
methylmethanesulfonate
Evaluation criteria:
A result was considered positive if a concentration-related increase in induced mutant frequency was observed in the treated cultures and one or more treatment conditions with 10% or greater total growth exhibited induced mutant frequencies of >= 90 mutants per million clonable cells (based on the average mutant frequency of duplicate cultures). If the average solvent control mutant frequency was >90 mutants per million clonable cells, a doubling of mutant frequency over the background will also be required.
A result was considered negative if the treated cultures exhibited induced mutant frequencies of less than 90 mutants per million clonable cells (based on the average mutant frequency of duplicate cultures) and there was no concentration-related increase in mutant frequency.
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

HQEE was considered to be non-mutagenic to mouse lymphoma cells in vitro.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

HQEE was considered to be non-mutagenic in an vivo micronucleus assay.

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay
Species:
mouse
Strain:
CD-1
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
0.5% CMC
Duration of treatment / exposure:
Oral gavage dose
Frequency of treatment:
Twice, at 0 and 24 hours
Post exposure period:
24 hours after second dose
Remarks:
Doses / Concentrations:
2000 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
10 males and 10 females
Control animals:
yes, concurrent vehicle
Positive control(s):
50 mg/kg Cyclophosphamide
Tissues and cell types examined:
Bone marrow from one femur
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Positive controls validity:
valid

No deaths or adverse reactions were observed following dosing.

Conclusions:
Interpretation of results: negative
HQEE was considered to be non-mutagenic in an vivo micronucleus assay.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Mode of Action Analysis / Human Relevance Framework

Not applicable

Additional information

The substance gave a negative results in an in vitro bacterial mutation assay and an in vitro gene mutation assay. It also gave negative results in an in vivo micronucleus assay. The requirement for an in vitro cytogenetics assay was waived on the basis that the results of an in vivo study were already available.

Short description of key information: the substance was negative in two in vitro genotoxicity assays and an in vivo genotoxicity assay.

Endpoint conclusion: No adverse effects obersved (negative).

Justification for classification or non-classification

The substance gave negative results in two in vitro gentoxicity assays and and in vivo assay. Therefore there is no requirement for classification.