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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

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other: Non-GLP, near-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment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
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

Constituent 1
Reference substance name:
64742-95-6
Cas Number:
64742-95-6
IUPAC Name:
64742-95-6
Constituent 2
Reference substance name:
Shellsol A
IUPAC Name:
Shellsol A
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 chemical
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 chemical
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 chemical
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.