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EC number: 203-197-3 | CAS number: 104-38-1
Endpoint summary
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.
Link to relevant study records
- 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
- 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
- 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.
Referenceopen allclose all
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
- 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
- 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
- Conclusions:
- Interpretation of results: negative
HQEE was considered to be non-mutagenic in an vivo micronucleus assay.
Reference
No deaths or adverse reactions were observed following dosing.
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.
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