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EC number: - | CAS number: -
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![](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:
- key study
- Study period:
- 11 August 2010 - .........................................
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; adeuqate coherence betwee data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- deviations to study plan but not to guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- idem above
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products
- Physical state: yellow liquid
- Purity: not indicated (complex composition)
- Lot/batch No.: LR_OXO_2010-07-12
- Date of analysis: 12 July 2010
- Expiration date of the lot/batch: July 2011
- Storage conditions of test material: at +4°C and under nitrogen gas.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Hypharm, La Corbière, Roussay, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 3.2 +/- 0.1 kg
- Housing: individually housed in Techniplast cages
- Diet (e.g. ad libitum): free access to breeding pelleted diet “type 110C”
- Water (e.g. ad libitum): tap water (filtered using a 0.22 µm filter) contained in bottles
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (7:00 - 19:00)
IN-LIFE DATES: From: 17 August 2010 To: 20 September 2010.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye, which remained untreated, served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL. - Duration of treatment / exposure:
- Single application to the eye.
- Observation period (in vivo):
- 6 days.
- Number of animals or in vitro replicates:
- Two males and one female.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize scale.
TOOL USED TO ASSESS SCORE: UV lamp and 0.5% sodium fluorescein solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: discharge also
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: whitish purulent discharge also
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity (intensity)
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity (intensity)
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity (intensity)
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight to marked chemosis and redness of the conjunctiva (grades 1 to 3) were observed in all animals from day 1 until day 2, 4 or 6. Clear and/or whitish purulent discharge was observed in two animals from day 2 until day 3 or 4.
Iris lesions were noted in one animal from day 1 until day 3.
A slight or moderate corneal opacity was recorded in two animals on days 2 and 3. - Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- The test item,distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, was slightly irritant when administered by ocular route to rabbits. However it does not need to be classified according to EU.
- Executive summary:
The objective of this study was to evaluate the potential of the test item, distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, to induce irritation following a single ocular administration in rabbitsaccording to OECD (No. 405, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.5, 30 May 2008) guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice.
Methods
The test item, distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products,was first administered to a single male New Zealand White rabbit.
Since the test item was not severely irritant on this first animal, it was then evaluated simultaneouslyon two other animals.
The quantity of the test item administered was 0.1 mL.
The test item was introduced into the conjunctival sac of the left eye. The right eye, which remained untreated, served as control.
The eyes were not rinsed after administration of the test item.
Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until the reversibility of the ocular reactions (at least day 7).
Body weight was recorded at the beginning and the end of the observation period. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post‑mortem examination.
The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.
The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).
Results
Slight to marked chemosis and redness of the conjunctiva (grades 1 to 3) were observed in all animals from day 1 until day 2, 4 or 6. Clear and/or whitish purulent discharge was observed in two animals from day 2 until day 3 or 4.
Iris lesions were noted in one animal from day 1 until day 3.
A slight or moderate corneal opacity was recorded in two animals on days 2 and 3.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 2.3 and 0.3 for chemosis, 1.7, 2.3 and 0.3 for redness of the conjunctiva, 0.0, 0.7 and 0.0 for iris lesions and 1.0, 1.3 and 0.0 for corneal opacity.
Conclusion
Under the experimental conditions of the study, the test item, distillation residues of butyraldehyde, 2-ethylhexenal and isobutanal hydrogenation by-products, was slightly irritant when administered by ocular route to rabbits.
However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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