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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Remarks:
Read-across to the test material (Shellsol A) is justified by the description of its composition – it is described as being composed of predominantly trimethylbenzenes, of which mesitylene is one.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, near-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
maximisation procedure of Magnusson B and Kligman AM (1969). The identification of contact allergens by animal assay, The Guinea Pig Sensitisation Test. J. Invest. Derm. 52, 268-276
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study conducted before implementation of REACH guideline, and existing data has been used.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Shellsol A
- Substance type: hydrocarbon solvent (essentially C9 isomers, particularly trimethylbenzenes)
- Physical state: liquid
- Source: Shell Nederland Raffinarderij B.V. refinery, Pernis, Rotterdam, The Netherlands

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: 'P' strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory Breeding Unit
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction 0.1% w/v; topical induction 50% w/v, topical challenge 25% w/v
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction 0.1% w/v; topical induction 50% w/v, topical challenge 25% w/v
No. of animals per dose:
10/sex for test group, 5/sex for control group
Details on study design:
no further data

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
negative control
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
1st, 2nd and 3rd reading (0, 24 and 48 h after challenge)
Reading:
2nd reading
Group:
negative control
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
1st, 2nd and 3rd reading (0, 24 and 48 h after challenge)
Reading:
other: 3rd reading
Group:
negative control
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
1st, 2nd and 3rd reading (0, 24 and 48 h after challenge)
Reading:
1st reading
Group:
test group
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
1st, 2nd and 3rd reading (0, 24 and 48 h after challenge)
Reading:
2nd reading
Group:
test group
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
1st, 2nd and 3rd reading (0, 24 and 48 h after challenge)
Reading:
other: 3rd reading
Group:
test group
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Remarks:
1st, 2nd and 3rd reading (0, 24 and 48 h after challenge)
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Shellsol A was not a skin sensitiser.
Executive summary:

Guinea pigs were challenged with Shellsol A in a maximization test. No sensitisation response was elicited immediately, 24 or 48 hours after the challenge. The test was therefore negative.