Registration Dossier
Registration Dossier
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EC number: 619-567-6 | CAS number: 848301-66-6
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: 481-670-5; 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 06-31-0126-00 from 1st Nov, 2006].
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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)
- Remarks:
- Huntington Life Sciences
Test material
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- 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:
- - Name of test material (as cited in study report): Shell MDS (M) Kerosine
- Lot/batch No.: 20001 1380
- Substance type: test substance 'Shell MDS(M) Kerosine' is a near analogue to 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear'; this substance is a limited range (C8-C12; boiling range ~160-200°C) Kerosine (Fischer-Tropsch), branched and linear alkane, which consists of approximately 50-60% linear and 40-50% branched material until ca. C12 when branching starts to increase. The branching consists almost exclusively of single methyl groups. There are mostly all mono branches below
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h after treatment and on day 8
- Number of animals or in vitro replicates:
- 6
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: 8d
- 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: 8d
- 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: 8d
- 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: 8d
- Remarks on result:
- other: max duration of effects: 24h
- Other effects:
- lnstillation of the test material caused a very slight to slight initial pain response.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance 'Shell MDS(M) Kerosine', a analogue to 'Kerosine (Fischer-Tropsch), full-range, C8-16-branched and linear' was not irritating to
rabbit eyes - it is therefore unclassified --> 'Kerosine (Fischer-Tropsch), full-range, C8-16-branched and linear' should also not be classified.
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