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EC number: 203-602-3 | CAS number: 108-64-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
In a combined repeated dose toxicity 28-day / Reproduction/Developmental Toxicity Screening Test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for 3 -methylbutyl isovalerate as a Read-across substance was 800 mg/kg bw/day (top dose).
In consideration of the molecular weight of both source and target substances (172.27 and 130.19 g/mol) the No Observed Adverse Effect Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity was 604.6 mg/kg/day.
Using this read across approach, the target substance is not classified for long term toxicity endpoints according to CLP.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-08-04 to 2017-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 800 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects of toxicological significance were observed.
- Key result
- Critical effects observed:
- no
- Conclusions:
- This study was conducted to evaluate the potential toxicity of the test substance on systemic toxicity when administered via oral gavage to Sprague-Dawley rats at dose levels of 0, 75, 250 and 800 mg/kg bw/day. There were no test item-related adverse systemic toxicity effects up to 800 mg/kg bw/day. Therefore, the No-Observed-Adverse-Effect Levels (NOAELs) for general toxicity is considered to be at least 800 mg/kg bw/day
- Executive summary:
This study was conducted to evaluate the potential toxicities of the test item regarding general systemic effects and reproductive/developmental toxicity. The test item was administered by oral gavage to Sprague-Dawley rats (12 animals per sex per group) at dose levels of 0, 75, 250 and 800 mg/kg with a dose volume of 2 mL/kg. Males and females were dosed for two weeks prior to mating and continued through the day before sacrifice in males (total 50 days), and continued through the lactation day (LD) 13 in females. Additional animals in the recovery groups 0 and 800 mg/kg (6 animals per sex per group) received the test item but were not mated. Afterwards, they were assigned to 2 weeks of recovery period after the completion of test item administration. General systemic observations including mortality, general clinical signs, body weights, body weight gain, food consumption, functional behavior examination, motor activity examination, macroscopic findings, hematology, coagulation, clinical chemistry, organ weights and microscopic findings were measured and evaluated. In addition, reproductive/developmental observations including estrus cycle, precoital time, fertility data, reproductive and littering findings, F1 pups clinical signs, body weight, anogenital distance, nipple retention and external examination were measured. Thyroid hormone (T4) level in blood was also analysed for adult males and pups at sacrifice.
No deaths or moribund animals occurred in any group throughout the study. One female of which all pups were found dead and which showed prolonged parturition, irregular respiration and skin paleness at 800 mg/kg was sacrificed unscheduled on gestation day (GD) 24.The relationship of test item administration and these findings was uncertain; however, they were not considered to have toxicological relevance since no test item-related adverse effects in other parameters at 800 mg/kg were observed during the study.
No test item-related change was observed up to 250 mg/kg. At 800 mg/kg, test item-related salivation was observed in both sexes but was not considered to have toxicological relevance. No test item-related change was observed in body weight, body weight gain, food consumption, functional behavior examination, motor activity examination, macroscopic findings, hematology, coagulation, clinical chemistry, organ weights and microscopic findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 604.6 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study was a read across from a good quality study, conducted using OECD Guideline 422 and complies with GLP and was therefore assigned 1 (reliable without restrictions).
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The No Observed Adverse Effect Levels (NOAELs) for general toxicity effects and reproduction/developmental of the target substance was predicted from the source substance (see read across justification).
In the key study, a source substance-related increase in thyroid hormone (T4) was observed in adult males at 800 mg/kg and in pups at 250 and 800 mg/kg. However, it was not considered to have toxicological relevance since there were no correlated changes in other parameters including microscopic findings of thyroids (with parathyroids).
In consideration of the molecular weight of both source and target substances (172.27 and 130.19 g/mol) the No Observed Adverse Effect Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity was 604.6 mg/kg/day.
A supporting 90-day repeat oral dose limit test was conducted with the test item in rats at up to 12.5 mg/kg/d in 1980. There was an increase in adrenal and thyroid weights (both absolute and relative) in both sexes. However there was no corresponding histopathology accompanying these changes suggestive of an adverse effect. As a result, the NOAEL from this study was at least 12.5 mg/kg/d.
This study was conducted according to the currently available protocols available at the time but is limited in its usefulness for characterizing the hazards of ethyl isovalerate. The supporting study was tested at low levels in a limit-test protocol and does not meet the current expectations for documentation. As a result, read-across was chosen as the preferred approach to complete the characterization of the repeat-dose hazards of the target substance.
Justification for classification or non-classification
No adverse effects were observed in the key combined repeated dose with the reproduction/developmental toxicity screening test (OECD 422) in rats for isoamyl isovalerate as a read-across substance; therefore, using a read across approach the test substance is not classificable as STOT RE according to CLP (Regulation EC No 1272/2008).
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