Registration Dossier

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: Standard method, GLP-compliant, adequate experimental details for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Buehler method: 3 occluded topical induction treatments, under occlusion, 1/week for 3 weeks followed by topical challenge.
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Concentration of test material and vehicle used at induction:
Undiluted, 0.4 ml

Concentration of test material and vehicle used for each challenge:
1% in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Concentration of test material and vehicle used at induction:
Undiluted, 0.4 ml

Concentration of test material and vehicle used for each challenge:
1% in paraffin oil
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 1 %

Evidence of sensitisation of each challenge concentration:
Very slight erythema seen in 1 test animal after challenge
at 1%: reaction not greater than seen among naive controls
challenged with test material at 1%. No other reactio
ns

Other observations:
Positive control group received 3x 0.3% DNCB inductions and
0.1% challenge.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of this study on the analogous substance, Renewable Diesel is not expected to be skin sensitiser.
Executive summary:

Based on the results of this study on the analogous substance, Renewable Diesel is not expected to be skin sensitiser.