Registration Dossier
Registration Dossier
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EC number: 203-620-1 | CAS number: 108-83-8
Toxicological information
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- incomplete experimental data
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 200 mg/kg bw
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of DIBK in rats is greater than 3200 mg/kg. Hence, no classification for acute oral toxicity is required according to EU criteria.
Assessed by the result of the oral LD50 of >3200mg/kg bw in rats Diisobutyl Ketone has not to be classified, but the insufficient data allows no classification.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- incomplete experimental data
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 200 mg/kg bw
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of DIBK in mice is greater than 3200 mg/kg. Hence, no classification for acute oral toxicty is required according to EU criteria.
Assesses by the result of the oral LD50 of >3200mg/kg bw in mice Diisobutyl Ketone has not to be classified, but the insufficient data allows no classification.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Incomplete experimental data
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Duration of exposure:
- 6 h
- Concentrations:
- 2.3-14.6mg/L air
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 12 days
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- 11.5 mg/L air
- Exp. duration:
- 6 h
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute inhalation LC50 of DIBK in rats was estimated to be 11500 mg/m3 after 6 hours of exposure. Hence, no classification for acute inhalation toxicity according to EU criteria is required.
The result of the LC50 of 11.5mg/L air for rats Diisobutyl Ketone allows no classification due to the insufficient data.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no experimental data
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Duration of exposure:
- 24h
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 16 mg/kg bw
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Although there was a result of the dermal LD50 of >16mg/kg bw for rats for Diisobutyl Ketone, the insufficient data allows no classification.
Although there was a result of the dermal LD50 of >16mg/kg bw for rats for Diisobutyl Ketone, the insufficient data allows no classification.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Incomplete experimental data
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- guinea pig
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- 24h
- Observation period:
- no data
- Number of animals:
- no data
- Irritant / corrosive response data:
- The test material is a strong irritant producing severe erythema, moderate edema and some scarring and eschar formation
- Conclusions:
- Since erythema and edema scores were not reported and the exposure duration was not conform current guidelines, the results of this study could not be used to derive a classification for skin effects
Although the test substance shows strong skin irritating and slightly corrosive effects the lack of information allows no classification.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Type of study:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. Group: test group. No with. + reactions: 2.0. Total no. in groups: 5.0.
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information
- Conclusions:
- 20% of the tested animals showed positive reactions, but the insufficient data allows no classification.
20% of the tested animals showed positive reactions, but the insufficient data allows no classification.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated dose inhalation daily for 5 days a week for 12 exposures
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl - Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Duration of treatment / exposure:
- 6h, 5 days per week, for a total of 12 exposure
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
2.3 mg/L
Basis:
no data - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes, not further specified
HAEMATOLOGY: Yes
- How many animals: all
- Parameters checked : emoglobin concentration, hematocrit and differential white cell count
CLINICAL CHEMISTRY: Yes
- How many animals: all
- Parameters checked: glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, lactic dehydrogenase, alkalin phosphatase, urea nitrogen and glucose
- Other examinations performed: organ weight (liver and kidney), behaviour - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, not further specified
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- HAEMATOLOGY
The total white cell count was slightly reduced as a result of a 50% reduction in the white blood cell count of two rats. Similar reductions were previously reported following inhalation exposures to ethyl n-butyl ketone and methyl n-butyl ketone (Toxicology Report No. 104733T). There were no treatment related gross or microscopic changes detected. Blood forming organs may be the site of toxic action. - Dose descriptor:
- NOAEC
- Effect level:
- 2.3 mg/L air
- Sex:
- not specified
- Critical effects observed:
- not specified
- Conclusions:
- Adverse effects on the total white blood cell count were observed and the NOAEC for Diisobutyl Ketone for repeated inhalative exposure was set to 2.3mg/L air (the higest dose tested). However the results and the experimental documentation are insufficient for classification.
Adverse effects on the total white blood cell count were observed and the NOAEC for Diisobutyl Ketone for repeated inhalative exposure was set to 2.3mg/L air (the higest dose tested). However the results and the experimental documentation are insufficient for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 10 day repeated open application to guinea pig
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,6-dimethylheptan-4-one
- EC Number:
- 203-620-1
- EC Name:
- 2,6-dimethylheptan-4-one
- Cas Number:
- 108-83-8
- Molecular formula:
- C9H18O
- IUPAC Name:
- 2,6-dimethylheptan-4-one
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: liquid
- Analytical purity: 65%
- Impurities (identity and concentrations): 32-35% 2-heptanone-4, 6-dimethyl
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- not specified
- Details on exposure:
- TEST MATERIAL
- Concentration (if solution): no data - Duration of treatment / exposure:
- 10 days
- No. of animals per sex per dose:
- 5
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
On day 1 slight to moderate erythema in 4 out of 5 animals On day 10 slight to moderate erythema in 4/5, slight edema in 5/5, eschars in 5/5. Repeated application exacerbates response. The insufficient data, especially on the concentration of the test substance, allows no classification.
Applicant's summary and conclusion
- Conclusions:
- The insufficient data, especially on the concentration of the test substance, allows no classification.
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