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EC number: 203-219-1 | CAS number: 104-61-0
- 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
- Acute toxicity: oral: Males LD50 = 6600 mg/kg bw (eq. OECD 401, K, rel.2)
- Acute toxicity: dermal: LD50 > 50000 mg/kg bw/d (WoE)
- Acute toxicity: inhalation: waiving
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similarly to OECD Guideline 401 with minor deviations: certificate of analysis not included, few details on test animals and environmental conditions, no data on number of animals showing signs of toxicity and pathological findings.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no data on age and source of animals; no data on housing and environmental conditions, number of animals showing signs of toxicity and pathological findings
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period before study (minimum): 16 h
- Food and water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- 4000, 5000, 6250, 7800 and 9700 mg/kg bw
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations for mortality were made at 1 and 6 h after dosing and daily thereafter for 14 days.
- Necropsy of survivors performed: Yes - Statistics:
- None
- Preliminary study:
- None
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 6 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 800 - 7 400
- Mortality:
- - Deaths occurred overnight to two days following administration of the test material.
- Mortalities in rats were 0, 30, 40, 80 and 100 % at 4000, 5000, 6250, 7800 and 9700 mg/kg bw, respectively. - Clinical signs:
- other: Piloerection and lethargy
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of γ-Nonalactone is higher than 5000 mg/kg bw in male rats therefore it is not classified according to the Directive 67/548/EEC and of the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In an acute oral toxicity study performed similarly to OECD test Guideline No. 401, groups of Wistar rats (10 males/dose) were given a single oral dose of γ-Nonalactone at 4000, 5000, 6250, 7800 or 9700 mg/kg bw. Animals were then observed for mortality at 1 and 6 h after dosing and daily thereafter for 14 days. Gross necropsies were performed on all survivors.
Mortalities in rats were 0, 30, 40, 80 and 100 % at 4000, 5000, 6250, 7800 and 9700 mg/kg bw, respectively. Clinical signs noted were piloerection and lethargy.
Oral LD50 Males = 6600 mg/kg bw (5800-7400).
The oral LD50 of γ-Nonalactone is higher than 5000 mg/kg bw in male rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) No. 1272 /2008 (CLP). This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 600 mg/kg bw
- Quality of whole database:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment. Substance purity is not mentioned.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no details
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- no details
- Duration of exposure:
- Single treatment
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- Total animals: 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- none
- Preliminary study:
- not applicable
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died on Day 1
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- Erythema lasted for 24 h
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of γ-Nonalactone is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In an acute dermal toxicity (limit test) study, a group of 4 rabbits were administered a single dermal dose of γ-Nonalactone at 5000 mg/kg bw. Animals were then observed for 14 days.
During the observation period, one animal died on Day 1. Erythema lasted for 24 h.
Dermal LD50 > 5000 mg/kg bw.
The dermal LD50 of γ-Nonalactone is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) No. 1272 /2008 (CLP).
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 50 000
- Quality of whole database:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies.
Additional information
Acute toxicity: oral
A key study was identified (Moreno, 1972, rel.2). In this acute oral toxicity study performed similarly to OECD test Guideline No. 401, male rats were given a single oral dose of γ-Nonalactone at 4000, 5000, 6250, 7800 or 9700 mg/kg bw. The oral LD50 (Males) was determined to be 6600 mg/kg bw. Clinical signs noted were piloerection and lethargy.
This result is supported by the study of Jenner (1964, rel.4) which estimated a combined rat LD50 of 9780 mg/kg bw (7480-12810) and a combined guinea-pig LD50 of 3440 mg/kg bw. A rat LD50 higher than 5000 mg/kg bw was also found by Levenstein (1976, rel.4).
By comparison, the combined LD50 of γ-Caprolactone, the “worst-case” substance used in the read-across approach (see §”Toxicokinetics” for read-across justification), was higher than 2000 mg/kg bw in a limit test performed similarly to the OECD test guideline No. 420 (Sunaga, 2002, rel. 2).
Acute toxicity: dermal
Two limit acute dermal toxicity studies were conducted on γ-Nonalactone, both showing LD50 values higher than 5000 mg/kg bw.
The first one (Moreno, 1972, rel.3) was conducted under non-standard conditions(i.e. abraded skin and occlusive dressing), and animals were observed only for 7 days.
The second one (Levenstein, 1976) was poorly documented but animals were observed for 14 days.
Therefore a weight of evidence approach was built using these two studies to substantiate the absence of acute dermal toxicity of γ-Nonalactone. Indeed, although several deviations were found in the first study, worst-case conditions were applied and only one animal died on Day 1. In the same way, although poorly described, observation period duration of the second study was available, confirming the results observed with a shortened observation period.
The dermal LD50 of γ-Nonalactone was therefore considered to be higher than 5000 mg/kg bw.
Acute toxicity: inhalation
No data was available. However, in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal route. Moreover, γ-Nonalactone has a low vapor pressure (1.9 Pa at 25 °C) and therefore the potential for the generation of an inhalable form is low.
Justification for selection of acute toxicity – oral endpoint
Key study conducted on γ-Nonalactone (eq. OECD 401, K, rel.2).
Justification for selection of acute toxicity – inhalation endpoint
No data was available. However, in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal route.
Justification for selection of acute toxicity – dermal endpoint
Weight of evidence approach with two studies conducted on γ-Nonalactone.
Justification for classification or non-classification
Harmonized classification:
γ-Nonalactone has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP2.
Self classification:
Based on the available data no additional self-classification is proposed regarding:
- both acute oral and dermal toxicity and,
- specific target organ toxicity - single exposure
according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC. No data were available by inhalation.
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