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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it closely followed OECD Guideline 406 and Good Laboratory Practices.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SX-50
-Substance type: Paraffin and hydrocarbon wax

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:
propylene glycol
Concentration / amount:
Intradermal induction: 3% w/v in propylene glycol (0.1 millilitres)
Topical induction: 50% propylene glycol (0.25 millilitres)
Topical challenge: 10% and 50% in propylene glycol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction: 3% w/v in propylene glycol (0.1 millilitres)
Topical induction: 50% propylene glycol (0.25 millilitres)
Topical challenge: 10% and 50% in propylene glycol
No. of animals per dose:
10 males, 10 females
Challenge controls:
5 males, 5 females treated with hexylcinammic aldehyde (50% and 30%)
Positive control substance(s):
yes
Remarks:
hexylcinammic aldehyde

Results and discussion

Positive control results:
Positive control (hexylcinnamaldehyde) was classified as a sensitiser and produced expected sensitisation response.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading:
Reading:
other: challenge
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading:
Reading:
other: challenge
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
other: challenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
other: challenge
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
other: challenge
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
hexylcinnamaldehyde
No. with + reactions:
5
Total no. in group:
5

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the study, paraffin wax is considered not sensitising in guinea pigs.
Executive summary:

In a dermal sensitisation study using paraffin wax, Dunkin Hartley albino guinea pigs (10/sex) were tested using the Magnusson & Kligman Guinea Pig Maximisation Test along with appropriate positive and negative controls. At the topical challenge phase, no skin reactions were observed at 24 or 48 hours in both the controls and groups treated with 10% or 50% paraffin wax in propylene glycol. There was a 0% sensitisation rate. Therefore, under conditions of this study, paraffin wax is not a dermal sensitiser.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely followed OECD Guideline 406 and Good Laboratory Practices.