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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was conducted prior to the development of the LLNA assay. This test material and this class of chemistry in general has not shown skin sensitisation effects.

Test material

Constituent 1
Chemical structure
Reference substance name:
Paraffin waxes and Hydrocarbon waxes, chloro
EC Number:
264-150-0
EC Name:
Paraffin waxes and Hydrocarbon waxes, chloro
Cas Number:
63449-39-8
Molecular formula:
C18H33Cl5 C18H30Cl8 C20H36Cl6 C20H33Cl9 C25H45Cl7 C25H42Cl10 C25H29C23 C30H53Cl9 C30H49Cl13 C30H35Cl27
IUPAC Name:
Paraffin waxes and Hydrocarbon waxes (C18 and longer), chloro
Details on test material:
C22-26; 42% Cl (liquid) (stabilised). Meflex DC016. Stabiliser: 0.2% epoxy soya bean oil, 0.3% Lubrizol LZ55A. 0.3% polyethylene glycol and 0.2% Nonox WSL.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
1st: Induction 5 % intradermal
2nd: Induction 20 % topical
3rd: Challenge 20 % topical
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
1st: Induction 5 % intradermal
2nd: Induction 20 % topical
3rd: Challenge 20 % topical
No. of animals per dose:
No data
Details on study design:
Induction was induced by the intradermal injection of a 5% solution of Meflex DC016 in olive oil homogenised with Freund's Complete Adjuvant, followed 7 days later by topical application of 20% solution of Meflex DC016 in olive oil. 2 weeks after topical induction, the animals were challenged with topical applications of 20% Meflex DC016 in olive oil. Erythema and oedema were scored after 24 and 48 hours.
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Clinical observations:
No erythem or oedema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Clinical observations: No erythem or oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Clinical observations:
No erythema or oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Clinical observations: No erythema or oedema.

Any other information on results incl. tables

No erythema (or oedema) developed in either the test or control animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There were no finding of sensitisation.
Executive summary:

There were no finding of sensitisation.