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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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 481-740-5; 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 06-31-0127-00 from 1st Nov, 2006].

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
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

Constituent 1
Reference substance name:
848301-66-6
Cas Number:
848301-66-6
IUPAC Name:
848301-66-6
Constituent 2
Reference substance name:
Kerosine (Fischer-Tropsch), C8-12, branched and linear
IUPAC Name:
Kerosine (Fischer-Tropsch), C8-12, branched and linear
Details on test material:
The study was conducted on a structural analogue, Shell MDS (M) kerosine. This substance is a limited range (C8-C12; boiling range ~160-200DegC) 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
composition is comparable to the test substance and hence read across is justified.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
72 h
Observation period (in vivo):
24, 48 and 72 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
0,4
Time point:
other: 3 days
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: max duration of effects: 72h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
0
Time point:
other: 3 days
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
Remarks:
0
Time point:
other: 3 days
Max. score:
0
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: max duration of effects: 0h
Irritation parameter:
iris score
Basis:
mean
Remarks:
0
Time point:
other: 3 days
Max. score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: max duration of effects: 24h

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 --> the structural analogue [BTL Diesel] to the test substance should also not be classified with regards to skin
irritation, and hence provides supporting evidence of 'negative findings' (Annex VI, EC/67/548).