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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 931-082-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study on supporting substance (with limited range, C8-C12) conducted in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear
- IUPAC Name:
- Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear
- Details on test material:
- - Substance type: Organic
- Physical state: Liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Isomers composition: Information not available
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Under cool conditions (approximately 4°C)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation:
Young rabbits, 4 to 5 months old
- Weight at study initiation: Individual body weights were recorded for each animal at test begin (2.28 to 3.54 kg) and at least weekly thereafter.
- Housing: Animals were individually housed in suspended stainless steel cages mounted in mobile batteries.
- Diet (e.g. ad libitum): Free access to standard pelleted diet.
- Water (e.g. ad libitum): Free access (ad libitum)
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15 to 23°C)
- Humidity (%): 55% R.H. (range 40% to 70% R.H.
- Air changes (per hr): Al least 10 complete air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h : 12 h
IN-LIFE DATES:
From: 13 March 1996 to 20 March 1996, sentinel animal: From: 11 March 1996 to 18 March 1996,
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 mL
- Concentration (if solution): pure test substance
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution): no vehicle used
- Lot/batch no. (if required): no vehicle used
- Purity: no vehicle used - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72h after treatment and on day 8 (one sentinel animal)
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyewashing phase was not undertaken
- Time after start of exposure: Not applicable
SCORING SYSTEM: Scoring in accordance to the mentioned guidelines.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein:
An ophthalmoscope or pencil beam torch was used to facilitate inspection of the eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: max duration of effects: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: max duration of effects: 24h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: max duration of effects: 0h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: max duration of effects: 24h
- Irritant / corrosive response data:
- Under the conditions of this test, the test item was considered to be non-irritating to the eye.
- Other effects:
- lnstillation of the test material caused a very slight to slight initial pain response.
Any other information on results incl. tables
Summary-Table of Results: Mean values for ocular lesions (24, 48 and 72 hours after instillation)
| Animal number and Sex | Corneal opacity | Iridial lesions | Redness of Conjunctiva | Chemosis |
| 32TD888, Female | 0.0 | 0.0 | 1.0 | 0.0 |
| 32TD899, Female | 0.0 | 0.0 | 0.3 | 0.0 |
| 32TD905, Female | 0.0 | 0.0 | 0.3 | 0.0 |
| 32TD955#, Female | 0.0 | 0.0 | 0.7 | 0.0 |
| 32TD971, Female | 0.0 | 0.0 | 0.0 | 0.0 |
| 32TD974, Female | 0.0 | 0.0 | 0.0 | 0.0 |
| Overall Mean Score | 0.0 | 0.0 | 0.4 | 0.0 |
#: Sentinel Animal, 72 h assessment undertaken 24 hours late
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No eye irritation was observed on the supporting substance with limited range (C8-C12); the analogue 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' should also not be classified with regards to eye irritation (Annex VI, EC/67/548 and EC 1272/2008).
- Executive summary:
The potential of the test item 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' (an analogue to 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear') to cause eye irritation on New Zealand White rabbits was investigated according to OECD guideline 405 and US-EPA OTS 798.4500 (Eye irritation). A volume of 0.1 mL test item was applied to six female rabbits.
Under the conditions of this test, 'Kerosine (Fischer-Tropsch), limited range, C8-12, branched and linear' was considered to be non-irritating to the eye. Finally, the analogue 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' should also be 'non-irritating' to the eye.
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.
