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EC number: 204-111-7 | CAS number: 115-84-4
- 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
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- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Dissociation constant
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- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
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- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 29 December 1987 to 18 January 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-butyl-1,3-propanediol
- IUPAC Name:
- 2-ethyl-2-butyl-1,3-propanediol
- Reference substance name:
- 2-butyl-2-ethylpropanediol
- EC Number:
- 204-111-7
- EC Name:
- 2-butyl-2-ethylpropanediol
- Cas Number:
- 115-84-4
- Molecular formula:
- C9H20O2
- IUPAC Name:
- 2-butyl-2-ethylpropane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): Ethyl butyl propanediol
- Physical state: colourless crystalline powder
- Analytical purity: 98.2%
- Storage conditions: at room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Rabbits were supplied by Rosemead Rabbits, Waltham Abbey, Essex, England. They were 12 to 13 weeks old and had a weight range of 2.8 to 3.2 kg, prior to treatment on Day 1. The animal room temperature was maintained at 19°C with a relative humidity at 30-70%. Air exchange was maintained at 19 air changes/hour and lighting was controlled to give 12 hours of artificial light (7:00 - 19:00) in each 24 hour period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL (80 mg)
- Duration of treatment / exposure:
- N/A, no rinse after instillation
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Ocular reactions were assessed at 1 hour and 1, 2, 3, 4, 7, and 14 days after instillation. Observation of the eyes was aided by the use of a handheld torch. The contralateral, untreated eye, acted as the integral control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-7h
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- The group mean scores for ocular reactions did not exceed the classification thresholds and so classification as an ocular irritant is not required. No reactions persisted to the conclusion of the study.
See table below. - Other effects:
- Easily discernible corneal opacities were seen in two of the animals. A diffuse opacity was seen in the third. Iritis was observed in only one animal 24-72 hours after instillation. A diffuse crimson colouration of the conjunctivae, accompanied by obvious swelling with partial eversion of the lids was observed in all three animals. All eyes were normal 7 or 14 days after instillation of the test material.
Any other information on results incl. tables
Scores for eye irritation
Rabbit number |
Region of eye |
One hour |
Days after instillation |
||||||
1 (24 h) |
2 (48 h) |
3 (72 h) |
4 |
7 |
14 |
||||
1792F |
Cornea |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
|
Chemosis |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
||
1793F |
Cornea |
1 |
1 |
2 |
2 |
2 |
2 |
0 |
|
Iris |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
||
Conjunctivae |
Redness |
1 |
2 |
2 |
2 |
2 |
1 |
0 |
|
Chemosis |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
||
1818F |
Cornea |
0 |
1 |
1 |
1 |
1 |
0 |
- |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
- |
||
Conjunctivae |
Redness |
2 |
2 |
1 |
1 |
1 |
0 |
- |
|
Chemosis |
2 |
1 |
1 |
1 |
0 |
0 |
- |
||
Mean scores for 24 – 72 hours |
|||||||||
Cornea |
1.33 |
||||||||
Iris |
0.22 |
||||||||
Conjunctival redness |
1.67 |
||||||||
Conjuctival chemosis |
1.22 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- BEPD was found to be irritating to the eye under the conditions of the study and requires classification (Category 2) under CLP.
- Executive summary:
Three New Zealand White Rabbits were treated with 0.1 mL (80 mg) of the test material, which was placed into the lower everted lid of one eye of each rabbit. The contralateral eye was left untreated and served as a control. Assessment of ocular damage/irritation was made at 1 hour and 1, 2, 3, 4, 7, and 14 days after instillation. Easily discernible corneal opacities were seen in two of the animals. A diffuse opacity was seen in the third. Iritis was observed in one animal only two days after installation. A diffuse crimson colouration of the conjunctivae, accompanied by obvious swelling with partial eversion of the lids was observed in all three animals. All eyes were normal seven or fourteen days after instillation of the test material. BEPD was found to be an eye irritant under the conditions of the study and requires classification (Category 2) under CLP.
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