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EC number: 245-509-0 | CAS number: 23235-61-2
- 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
- Study period:
- 25 June 1995 - 30 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed to GLP and according to appropriate OECD and EC Test Guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- EC Number:
- 245-509-0
- EC Name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- Cas Number:
- 23235-61-2
- Molecular formula:
- C12H26O5
- IUPAC Name:
- 2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): Di-TMP (flakes), Di-Trimethylolpropane
- Physical state: Irregular white crystalline flakes
- Lot/batch No.: 54001-80
- Storage condition of test material: Kept in a tight-fitting container at room temperature in the dark
- Other:Test article characterisation (purtiy, solubility and stability etc.) was the responsibility of the Sponsor.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mølle-gaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved.
- Weight at study initiation: 2.4 kg
- Housing: Animals housed individually in PPO/HIPS (Noryl) cages (floor area: 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): Pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted. Available ad libitum.
- Water (e.g. ad libitum): Free access to bottles containing domestic quality drinking water acidified with hrdyochloric acid to pH 2.5
- Acclimation period: At least one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3ºC.
- Humidity (%): 55±15%.
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light):12 hours light / 12 hours darkness.
IN-LIFE DATES: From: 25 June 1995 To: 30 June 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye in each animal was treated with test material; the right eye was untreated and used as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g - Duration of treatment / exposure:
- Eye lids held shut for 1 second following instillation of the test material into the eye. Exposure was otherwise instantaneous.
- Observation period (in vivo):
- Eyes were observed after 1, 24, 48, and 72 hours from exposure. After the initial 24 hour assessment, Fluorescein was instilled, the eyes rinsed with saline solution and the eyes examined again using UV light.
- Number of animals or in vitro replicates:
- 3 female rabbbits.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes rinsed following Fluorescein instillation (24 hours) but no dedicated rinsing performed following test substance exposure.
SCORING SYSTEM: Scoring of irritation was largely consistent with the scheme detailed in OECD test guideline 405. Evaluation of scores was based on The Official Journal of the European Communities, L110A, 1993, teh directive of teh comission 93/21/EEC of April 27, 1993.
TOOL USED TO ASSESS SCORE: Fluorescein used, as detailled previously. Also used was a hand held inspection lamp fitted with white and UV-light and magnifying glass with 2x magnification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Moderate conjuntival irritation (chemosis, redness, discharge) was observed in all rabbits 1 to 48 hours after exposure. Slight corneal opacity was
seen in all rabbits 1 to 24 hours after exposure and in two rabbits 48 hours after exposure. At 72 hours no abnormalities were observed.
Any other information on results incl. tables
Scores for ocular lesions
Rabbit No. / Weight kg |
Effect and severity |
1 hr |
24 hrs, F |
48 hrs, F |
72 hrs, F |
Individual mean score |
7695 / 2.4 |
Corna opacity, area |
1 |
2, 2 |
1, 1 |
0, 0 |
|
Cornea opacity, degree |
1 |
1 |
0 |
0 |
0.33 |
|
Iris |
0 |
1 |
0 |
0 |
0.33 |
|
Conjunctiva chemosis |
2 |
2 |
0 |
0 |
0.67 |
|
Conjunctiva redness |
2 |
2 |
2 |
0 |
1.33 |
|
Conjunctiva discharge |
3 |
0 |
0 |
0 |
|
|
76977/ 2.4 |
Corna opacity, area |
4 |
1, 1 |
1, 1 |
0, 0 |
|
Cornea opacity, degree |
1 |
1 |
1 |
0 |
0.67 |
|
Iris |
0 |
1 |
0 |
0 |
0.33 |
|
Conjunctiva chemosis |
3 |
3 |
1 |
0 |
1.33 |
|
Conjunctiva redness |
1 |
2 |
2 |
0 |
1.33 |
|
Conjunctiva discharge |
2 |
0 |
0 |
0 |
|
|
7680 / 2.4 |
Corna opacity, area |
4 |
1, 1 |
1, 1 |
0, 0 |
|
Cornea opacity, degree |
1 |
1 |
1 |
0 |
0.67 |
|
Iris |
0 |
1 |
0 |
0 |
0.33 |
|
Conjunctiva chemosis |
4 |
3 |
1 |
0 |
1.33 |
|
Conjunctiva redness |
2 |
2 |
1 |
0 |
1.00 |
|
Conjunctiva discharge |
2 |
0 |
0 |
0 |
|
F: reading after instillation of oculoguttae fluoresceini
Only the scores from the 3 readings (24, 48, and 72 hours) are included in the calculation of the individual mean scores.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, Di-TMP was found to be a moderate eye irritant but does not require classification as an eye irritant according to the CLP Regulation.
- Executive summary:
An eye irritation study was performed to determine the potential for irritation to eyes when 0.1g of the test substance Di-TMP was administered to the left eye of three rabbits. The study was conducted to GLP and according to OECD 405 and EC B5 Test Guidelines. Moderate conjunctival irritation (chemosis, redness, discharge) was observed in all rabbits 1 to 48 hours after exposure. Slight corneal opacity was seen in all rabbits 1 to 24 hours after exposure and in two rabbits 48 hours after exposure. At 72 hours no abnormalities were observed. Under the conditions of this study, Di-TMP was found to be a moderate eye irritant but does not require classification as an eye irritant according to the CLP Regulation.
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