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EC number: 205-619-1 | CAS number: 144-19-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted prior to introduction of Good Laboratory Practices; data from a summary report; limited number of animals. Study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines.
Data source
Reference
- Reference Type:
- other: Toxicology Summary
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not specified
- Principles of method if other than guideline:
- Twenty guinea pigs were divided into three groups containing 5 animals each (solvent and positive control) or 10 animals (TMPD). Ten animals were treated with the test substance at a concentration of 1% in a mixture of 1:1:3 acetone:dioxane:guinea pig fat. Five animals were treated with the vehicle alone, and five animals were administered a positive control substance (phenylhydrazine). The mixtures were applied epicutaneously to the clipped backs of the guinea pigs. Average irritation scores were noted at 24 and 48 hours after the first application. The materials were periodically reapplied to the guinea pig backs for two weeks. After the last application, the average irritation scores were again obtained after 24 and 48 hours. Results from the initial and final applications were compared to determine whether the test substance had caused a positive skin sensitization response.
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLPs
- Type of study:
- other: internal Eastman Kodak method
Test material
- Reference substance name:
- 2,2,4-trimethylpentane-1,3-diol
- EC Number:
- 205-619-1
- EC Name:
- 2,2,4-trimethylpentane-1,3-diol
- Cas Number:
- 144-19-4
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2,2,4-trimethylpentane-1,3-diol
- Details on test material:
- -Identity (according to study report): 2,2,4-trimethyl-1,3-pentanediol (TMPD)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 1:1:3 acetone:dioxane:guinea pig fat
- Concentration / amount:
- 1%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 1:1:3 acetone:dioxane:guinea pig fat
- Concentration / amount:
- 1%
- No. of animals per dose:
- TMPD: 10 animals
Solvent control: 5 animals
Positive control: 5 animals - Details on study design:
- Twenty guinea pigs were divided into three groups containing 5 animals each (solvent and positive control) or 10 animals (TMPD). Ten animals were treated with the test substance at a concentration of 1% in a mixture of 1:1:3 acetone:dioxane:guinea pig fat. Five animals were treated with the vehicle alone, and five animals were administered a positive control substance (phenylhydrazine, concentration not reported). The mixtures were applied epicutaneously to the clipped backs of the guinea pigs. Average irritation scores were noted at 24 and 48 hours after the first application. Scores were calculated by adding together the erythema scores from each animal and the edema scores from each animal. The sum of the scores was then divided by the number of readings. The materials were periodically reapplied to the guinea pig backs for two weeks. After the last application, the average irritation scores were again obtained after 24 and 48 hours. Results from the initial and final applications were compared to determine whether the test substance had caused a positive skin sensitization response. The 48 hour scores were deemed more important in the determination of sensitization than the 24 hour scores, which were considered more reflective of cumulative irritation.
- Positive control substance(s):
- yes
- Remarks:
- Phenylhydrazine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Average initial score
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The average initial irritation score 24 hours after the first application was 1.0.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average initial score. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: The average initial irritation score 24 hours after the first application was 1.0. .
- Reading:
- other: Average initial score
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- The average initial irritation score 24 hours after the first application was 1.0.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average initial score. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The average initial irritation score 24 hours after the first application was 1.0. .
- Reading:
- other: Average initial score
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 M
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The average initial irritation score 24 hours after the first application was 2.0.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average initial score. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 M. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: The average initial irritation score 24 hours after the first application was 2.0. .
- Reading:
- other: Average initial score
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The average initial irritation score 48 hours after the first application was 1.0.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average initial score. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: The average initial irritation score 48 hours after the first application was 1.0. .
- Reading:
- other: Average initial score
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- The average initial irritation score 48 hours after the first application was 1.0.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average initial score. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: The average initial irritation score 48 hours after the first application was 1.0. .
- Reading:
- other: Average initial score
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 M
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The average initial irritation score 48 hours after the first application was 2.4.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average initial score. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 M. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: The average initial irritation score 48 hours after the first application was 2.4. .
- Reading:
- other: Average final score
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The average final irritation score 24 hours after the last application was 1.1.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average final score. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: The average final irritation score 24 hours after the last application was 1.1. .
- Reading:
- other: Average final score
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- The average final irritation score 24 hours after the last application was 1.5.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average final score. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: The average final irritation score 24 hours after the last application was 1.5. .
- Reading:
- other: Average final score
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 M
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- The average final irritation score 24 hours after the last application was 3.7.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average final score. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 M. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: The average final irritation score 24 hours after the last application was 3.7. .
- Reading:
- other: Average final score
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The average final irritation score 48 hours after the last application was 1.1.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average final score. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: The average final irritation score 48 hours after the last application was 1.1. .
- Reading:
- other: Average final score
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- The average final irritation score 48 hours after the last application was 1.6.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average final score. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: The average final irritation score 48 hours after the last application was 1.6. .
- Reading:
- other: Average final score
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 M
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- The average final irritation score 48 hours after the last application was 3.2.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: Average final score. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 M. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: The average final irritation score 48 hours after the last application was 3.2. .
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information
- Conclusions:
- When 2,2,4-trimethyl-1,3-pentanediol was tested in a repeated epicutaneous application sensitization study, 2 of the 10 animals showed a weak response. Final average scores in treated animals 24 and 48 hours after the last application of test material were 1.5 and 1.6, respectively. These average scores were significantly lower than those observed for the positive control. While a weak response was observed in 2 of 10 animals tested, the test method used in this study is not one of the three recognized and officially accepted animal test methods outlined in current regulatory guidelines. Two other skin sensitization studies conducted by non-guideline methods are available for this test material and should also be considered in the final determination of skin sensitization classification.
2,2,4-Trimethyl-1,3-pentanediol is not currently classified for skin sensitization according to Directive 67/548/EEC. Based on the weak positive response in the current study, data were considered to be insufficient to classify the test material for Skin Sensitization according to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) 1272/2008. - Executive summary:
In a skin sensitization study, ten guinea pigs were repeatedly exposed to 2,2,4-trimethyl-1,3-pentanediol at a concentration of 1% in a vehicle consisting of 1:1:3 acetone:dioxane:guinea pig fat. Applications were made epicutaneously on the clipped backs of the animals over a two week period. Animals were observed at 24 and 48 hours for signs of irritation after both the first and last applications of the test substance. Average irritation scores for animals treated with the test material were compared to scores obtained from groups of five animals treated with the vehicle alone or a solution containing the positive control substance phenylhydrazine. Under the conditions of the current study, the test substance, 2,2,4-trimethyl-1,3-pentanediol, induced a low level of sensitization in 2 of 10 animals. The positive and solvent control substances induced the appropriate responses. Based on the minimal response observed in this study, 2,2,4-trimethyl-1,3-pentanediol (TMPD) presents a low potential for dermal sensitization.
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