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Diss Factsheets
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EC number: 214-222-2 | CAS number: 1115-20-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 20 h occlusive exposure
- Principles of method if other than guideline:
- Skin irritation was tested using an internal method (BASF test)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate
- EC Number:
- 214-222-2
- EC Name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate
- Cas Number:
- 1115-20-4
- Molecular formula:
- C10H20O4
- IUPAC Name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate
- Details on test material:
- - Name of test material (as cited in study report): Hydroxypivalinsaeureneopentylglykolester (HPN)
- Physical state: solid
no further details
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- One females, initial weight: 2.61 and one male, initial weight 2.84 kg
no further details
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 80% test substance (w/v) in distilled water was used. The application site was covered with an cotton patch of 2.5 X 2.5 cm; prior application of the test substance to the patch, amount not reported (presumably patch soaked with the test substance); no further data.
- Duration of treatment / exposure:
- 1, 5, or 15 minutes or 20 h
- Observation period:
- Results were recorded each working day for up to 7 days. Scoring was done 24 h, 48 h and 5 and 7 days after initiation.
- Number of animals:
- 2 rabbits
- Details on study design:
- After the reported exposure time, the skin was washed with 50% Lutrol in water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects were detected after 1, 5, or 15 minutes of exposure; no effects were seen after 20 h occlusive application (see Table below).
No edema was reported in any experiment. - Other effects:
- Body weight not altered.
Any other information on results incl. tables
Skin erythema in 2 rabbits after dermal exposure to the undiluted test substance for 20 h followed by washing with 50% Lutrol
Time after initiation of exposure |
20 hours exposure; erythema in |
|
Rabbit 1 |
Rabbit 2 |
|
24 h |
0 |
0 |
48 h |
0 |
0 |
5 days |
0 |
0 |
7 days |
0 |
0 |
Evaluation transformed to OECD-Draize scoring; no edema reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- The test substance has no skin irritant properties.
- Executive summary:
The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period 20 h and occlusive coverage conditions [worst case scenario]).
Two rabbits were dermally exposed to moistened test substance for 1, 5, 15 minutes or for 20 h. The coverage was occlusive; the skin was washed after exposure. Skin reaction was scored 24 & 48 h, and 5 and 7 days initiation. No erythema was found. No edema was reported.
Conclusion: The test substance has no skin irritant properties.
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