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EC number: 207-938-1 | CAS number: 502-44-3
- 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
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- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- 4th November to 2nd December 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Proprietary study conducted according to guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hexan-6-olide
- EC Number:
- 207-938-1
- EC Name:
- Hexan-6-olide
- Cas Number:
- 502-44-3
- Molecular formula:
- C6H10O2
- IUPAC Name:
- oxepan-2-one
- Reference substance name:
- e-caprolactone
- IUPAC Name:
- e-caprolactone
- Details on test material:
- e-Caprolactone, a viscous liquid, supplied by Solvay S.A. Brussels. Batch No: WA2809/0791. Purity: >99%. Prior to dosing, the material was stored in a refrigerator.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- SPF-derived male New Zealad White rabbits (one animal weighed 1.8-2.2kg, three weighed 2.5-3.0kg), obtained from Harlan Olac. Animals underwent an 11 day acclimatisation period. Rabbits were housed individually in stainless steel wire cages without sawdust or woodchips (i.e. no extraneous material that might produce eye irritation). They received 80g food per day (standard laboratory diet), with free access to the food and water. Temperature of the animal room was maintained at 19-22oC, relative humidity 52-72%, artificial light from 7am till 7pm, radio-sound from 7am till 7pm, and approximately 16 air changes per hour.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1ml e-Caprolactone applied to conjunctival sac.
- Duration of treatment / exposure:
- Substance was applied to conjunctival sac, and eyelid held closed for approximately 1 second.
- Observation period (in vivo):
- Observations were made at 1, 24, 48, 72 hours and 7 days after treatment.
- Number of animals or in vitro replicates:
- Initially 4 animals were used, one of these animals was injured and euthanased 1 hour post-treatment. A replacement rabbit was obtained from the supplier.
- Details on study design:
- Four rabbits were used. 0.1ml test substance was dropped into the conjuctival sac of the left eye. Eye reactions were scored at 1, 24, 48, 72 hours and 7 days after treatment. The scoring system used was that according to Draize (1944), and the results were interpreted according to the Commission Directive 91/325/EEC. The right eye remained untreated to serve as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- At 1 hour very slight opacity, iritis, redness and very slight chemosis were observed in three rabbits, and slight iritis, redness and chemosis was observed in the fourth. Severe discharge was observed in animal's 1-3 and moderate discharge in animal 4. The following observations are limited to 3 animals: at 24 hours slight opacity and iritis were observed, slight to moderate redness was observed. Very slight to sight chemosis was observed. At 48 hours opacity was very slight to slight. Redness was slight to moderate. Chemosis was very slight. At 72 hours very slight to slight opacity and slight iritis were observed. Slight to moderate redness were observed. All symptoms had disappeared by day 7.
- Other effects:
- No additional effects.
Any other information on results incl. tables
Scores for ocular effects
Observation |
1h |
24h |
48h |
72h |
Mean (24-72h) |
7d |
|
Cornea |
Opacity |
1,1,0 |
2,2,2 |
2,2,1 |
2,2,1 |
1.78 |
0,0,0 |
Iris |
Lesion |
1,1,1 |
1,1,1 |
1,1,1 |
1,1,0 |
0.89 |
0,0,0 |
Conjunctivae |
Erythema |
1,1,1 |
2,2,1 |
1,2,1 |
1,2,1 |
1.44 |
0,0,0 |
Chemosis |
1,1,2 |
2,1,1 |
1,1,1 |
0,1,0 |
0.89 |
0,0,0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to labelling regulations e-Caprolactone is classified as irritating to the eye.
- Executive summary:
The primary irritation of e-Caprolactone to the eye of male rabbits was determined in this guideline study. 0.1ml substance was introduced to the conjunctival sac of the left eye of three rabbits (the right eye remained untreated to serve as a control). The eyes of the rabbits were examined and the ocular reactions graded at intervals up to and including 7 days after treatment. Various signs of irritation were observed (corneal opacity, iris lesion, conjunctival erythema, chemosis and discharge), lthough all symptoms were reversible by Day 7. The substance requires classification as an eye irritant according to Regulation (EC) No 1272/2008 (CLP) and according to Directive 67/548/EEC. It is classified as an eye irritant and assigned the symbol Xi and the risk-phrase R36 "Irritating to eyes". It is an eye irritant category 2 and is assigned the pictogram GHS07 with the signal word "warning" and the hazard statement H319 "causes serious eye irritation".
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