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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Huntington Life Sciences
Type of study:
Freund's complete adjuvant test

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'.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Concentrations of test material and vehicle used at each stage of induction:
- First induction: 50% w/v in paraffin oil
50% w/v in FCA
- Topical induction: undiluted as supplied

Concentrations of test material and vehicle used at each stage of challenge:
- Topical challenge: 50% v/v in paraffin oil
10% v/v in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentrations of test material and vehicle used at each stage of induction:
- First induction: 50% w/v in paraffin oil
50% w/v in FCA
- Topical induction: undiluted as supplied

Concentrations of test material and vehicle used at each stage of challenge:
- Topical challenge: 50% v/v in paraffin oil
10% v/v in paraffin oil
No. of animals per dose:
TEST GROUP: 20 (10m/10f)
CONTROL GROUP: 20 (10m/10f)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
eschar formation and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% (v/v)
No. with + reactions:
17
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (v/v). No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (v/v)
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
eschar formation and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (v/v)
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (v/v)
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (v/v). No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
paraffin only
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: paraffin only. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (v/v)
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
eschar formation and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (v/v). No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: eschar formation and oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (v/v)
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (v/v). No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% (v/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
eschar formation and odema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% (v/v). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: eschar formation and odema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 % (v/v)
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % (v/v). No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% (v/v)
No. with + reactions:
16
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% (v/v). No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: exfoliation.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
paraffin only
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
exfoliation
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: paraffin only. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: exfoliation.

Any other information on results incl. tables

Signs of irritation during induction: 50% v/v - moderate erythema and oedema; no dermal response was evident following a similar administration of 50% v/v of test material in paraffin oil.

Occluded topical induction of test material as supplied gave rise to slight erythema, eschar formation, exfoliation, yellow staining, loss of flexibility and oedema.

Evidence of sensitization at each challenge: Challenge application of 50% v/v test material in paraffin oil gave rise to eschar formation or oedema in six test and five control animals. Exfoliation was evident in seventeen test and nineteen control animals. Challenge application of 10% v/v test material in paraffin oil caused eschar formation in two test and no control animals; a further seven test and two control animals showed slight erythema. Exfoliation was evident in twelve test and sixteen control animals. Challenge application of paraffin oil alone gave rise to slight erythema in two control animals. Exfoliation was evident in thirteen test and fourteen control animals. On this basis it is considered that a significant dermal response was observed in no test animal following challenge with 50% v/v test material in paraffin oil and in two test animals following challenge application of 10% v/v test material in paraffin oil.

Other observations: Abrasions were evident in the majority of test animals after second (topical) induction; the control animals remained in overt good health. One test animal was found dead on Day 2; necropsy revealed incomplete collapse of the lungs. All surviving animals achieved anticipated overall bodyweight gains.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
It was concluded that, under the conditions of this study, repeated administration of 'Shell MDS (M) Kerosine', a analogue to
'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' had a weak potential to cause delayed contact hypersensitivity in guinea pigs.
However, the incident of significant response was below the EEC trigger threshold for classification as a dermal sensitizer.