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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin 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:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Huntington Life Sciences

Test material

Constituent 1
Reference substance name:
unknown
IUPAC Name:
unknown
Constituent 2
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 --> the test substance 'Shell MDS (M) Kerosine' is comparable to 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear'.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 h
Observation period:
16 d
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 days
Score:
0.89
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max duration of effect: 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 days
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max duration of effect: 7 days
Other effects:
Exfoliation was evident at all test sites from Day 7 until termination on Day 16. The exfoliation observed at termination of the study probably reflected a recovery process from a drying effect of the test material.

Applicant's summary and conclusion

Interpretation of results:
slightly 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 considered to be slightly irritating to rabbit skin. According to Annex VI of Council Directive 67/548/EEC the test substance is unclassified with regards to skin irritation --> 'Kerosine (Fischer-Tropsch), full-range, C8-16-branched and linear' should also not be classified.