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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 50 mg instead of 100 mg test substance instilled; not washed out but comparison with talcum powder was given; max. observation period only 8 days, 21 days recommended).
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (scorring system); 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 data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Two males, initial bw 3.07 or 3.17 kg
no further details
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: same amount talcum powder into the conjunctival sac of the left eye
- Amount / concentration applied:
- ca. 50 mg instilled into the conjunctival sac
- Duration of treatment / exposure:
- unwashed
- Observation period (in vivo):
- up to 8 days after application; see Table in the result section.
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- Scar formation was observed at day 6 in animal #1; ciliary injection at day 6 and scar formation at day 8 was observed in animal #2.
Small effects were also detected in the left eye (talcum control; mechanical irritation): slight redness (Draize conjunctivae score 1) which was completely reversible within 6 days (animal #1) and 24 h (animal #2). - Other effects:
- no effects on body weight
no further data
Any other information on results incl. tables
Eye irritation in 2 rabbits after instillation of 50 mg test
substance
Scoring according to OECD-Draize scheme; description of
effects from raw data
Time period after application |
Rabbit 1 |
Rabbit 2 |
Erythema |
||
1 h |
1 |
1 |
24 h |
2 |
1 |
48 h |
2 |
2 |
72 h |
1 |
2 |
6 days |
1 |
1 |
8 days |
0 |
1 |
Time period after application |
Rabbit 1 |
Rabbit 2 |
Edema |
||
1 h |
2 |
1 |
24 h |
1 |
2 |
48 h |
0 |
2 |
72 h |
0 |
2 |
6 days |
0 |
1 |
8 days |
0 |
1 |
Time period after application |
Rabbit 1 |
Rabbit 2 |
Corneal opacity and other effects |
||
1 h |
1 (discharge) |
1 |
24 h |
2 (discharge) |
1 |
48 h |
2 (cornea covered by a smeary film) |
2 (discharge) |
72 h |
2 (cornea covered by a smeary film) |
2 (ulceration) |
6 days |
2 (scar formation) |
2 (ciliary injection) |
8 days |
1 (scar formation) |
2 (scar formation) |
Raw data not clearly compatible with results described in the summary protocol
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Conclusions:
- The instillation of 50 mg test substance into the conjunctival sac of rabbit eyes resulted in irreversible effects.
- Executive summary:
The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 50 mg instead of 100 mg test substance instilled).
An amount of 50 mg test substance was instilled into the right eye of 2 rabbits; the left eye served as control (50 mg talcum powder instilled). Effects were recorded 1, 24, 48, 72 h and up to 8 days after instillation. Edema and corneal opacity OECD score 2 were reported in both rabbits as well as ulceration (one rabbit) and scar formation (both rabbits). Corneal opacity was still present in both rabbits 8 days after instillation.
Conclusion: The instillation of 50 mg test substance into the conjunctival sac of the rabbit eyes resulted in irreversible effects.
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