Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-155-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 8 March 2011 to 29 April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- corn oil, peroxidised
- IUPAC Name:
- corn oil, peroxidised
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Crl:CHBB (HM) Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kissleg
- Age at study initiation: > 12 months old
- Weight at study initiation: 3.3kg, 2.9kg and 3.3kg
- Housing: individually in PPO cages (floor area: 2576 cm²)
- Diet: pelleted complete rabbit diet "Altromin 2123", ad libitum
- Water (e.g. ad libitum): free access to bottles with drinking water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C +/- 3°C
- Humidity: preferably at least 30% and preferably no exceding 70%
- Air changes (per hr): 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: from 4 April 2011 to 15 April 2011
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Only one eye was treated. The other eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD TG 405
TOOL USED TO ASSESS SCORE: UV-light / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: (0.00, 0.00, 0.00)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: (0.00, 0.00, 0.00)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (0.33, 0.33, 0.33)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (0.33, 0.00, 0.00)
- Irritant / corrosive response data:
- One hour after the application of the test item, the animals showed some hyperaemic conjunctival blood vessels and a swelling above normal.
24 hours after the application of the test item, some hyperaemic conjunctival blood vessels and a swelling above normal were observed in one animal. Two animals showed some hyperaemic conjunctival blood vessels.
After instillation of Fluorescein opacity of the cornea was revealed in none of the three animals.
48 hours and 72 hours after the application of the test item, the three animals were free of any signs of eye irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Peroxidised corn oil is not irritating to the eyes.
- Executive summary:
In a primary eye irritation study according to OECD TG 405 and GLP (Vaeth, 2011), 0.1 mLof undiluted peroxidised corn oil was instilled into the conjunctival sac of one eye of three females Russian rabbits for 24 hours. Animals then were observed for 72 hours. Irritation was scored according to the guideline.
The following mean values, based on the results from the 24-hour, 48-hour and 72-hours readings were calculated:
Animal No.
Opacity of the cornea
Iris lesion
Redness of conjunctivae
Oedema of conjunctivae
1
0.00
0.00
0.33
0.33
2
0.00
0.00
0.33
0.00
3
0.00
0.00
0.33
0.00
Based on the results, peroxidised corn oil shall not be classified as irritating to the eyes according to categories 1 or 2 of the CLP regulation.
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.
