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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-566-0 | CAS number: 848301-65-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This endpoint has been reviewed, assessed and accepted by UK-HSE as competent authority for the notification of a new substance [EC number: 481-730-0; Data from UK-Notification Dossier by Shell U.K. Limited in accordance with Directive 92/32/EEC (Articles 7/8/9/12) O.J.L 154, Volume 35, 5 June 1992; Notification Report 06-31-0125-00 from 1st Nov, 2006].
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- Deviation: During the study period, the temperature of the animal room ranged from 21° to 24°C. According to the OECD guideline 405 the
temperature of the experimental animal room should be 20°C (± 3°C). This deviation is not considered to have an effect on the validity of the study. - GLP compliance:
- yes
- Remarks:
- American Petroleum Institute
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): API-83-19, which is Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Substance type: test substance API-83-19 is a near analogue to Naphta (Fischer-Tropsch), light, C4-10 - branched and linear; it`s defined as:
'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers
predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'
--> the test substance API 83-19, which has been tested under an American Petroleum Institute programme, is comparable to 'Naphtha (Fischer-
Tropsch), light, C4-10 - branched and linear' and therefore read across is valid.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (eyes unflushed after dosing);
3 animals (eyes flushed 1 min after dosing with lukewarm water)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- - no pain response (vocalization) was elicted from any animal following instillation of the test material
- no signs of ill health were observed during the study
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No corneal or iridial irritation was seen during the study. All irritation had cleared by the 24-hour observation. On the basis of the test results and in
conformity with the criteria given in Annex VI of the Directive, the test substance 'Naphtha (petroleum), light alkylate' should be classified as 'not
irritating' --> 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' should be also classified as 'not irritating'.
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.
