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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
14 January 1979 - 27 June 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to methods resembling OECD guideline 406 but pre-GLP. The study report was concise but sufficient for use in a Weight of Evidence approach.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
in negative control: number of control animals
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Vetyvert Bourbon
IUPAC Name:
Vetyvert Bourbon
Details on test material:
- Name of test material (as cited in study report): Vetyvert Bourbon
- Physical state: Cream
- Lot/batch No.: Confidential information

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal: 0.01% dobs/saline, epicutaneous: ethanol
Concentration / amount:
Intradermal induction: 0.5%
Topical induction: 10%
Topical challenge: 2.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: intradermal: 0.01% dobs/saline, epicutaneous: ethanol
Concentration / amount:
Intradermal induction: 0.5%
Topical induction: 10%
Topical challenge: 2.5%
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: treated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: treated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 9.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: treated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: treated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 2.0. Total no. in groups: 9.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
1
Total no. in group:
9
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: 3rd challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
2
Total no. in group:
9
Remarks on result:
other: Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 2.0. Total no. in groups: 9.0.
Reading:
other: 3rd challenge
Hours after challenge:
24
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: 3rd challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
1
Total no. in group:
9
Remarks on result:
other: Reading: other: 3rd challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
Reading:
other: 3rd challenge
Hours after challenge:
48
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: 3rd challenge. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: 4th challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
1
Total no. in group:
9
Remarks on result:
other: Reading: other: 4th challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
Reading:
other: 4th challenge
Hours after challenge:
24
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: 4th challenge. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: 4th challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
1
Total no. in group:
9
Remarks on result:
other: Reading: other: 4th challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
Reading:
other: 4th challenge
Hours after challenge:
48
Group:
other: untreated control group
Dose level:
2.5% Vetyvert Bourbon
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: 4th challenge. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.

Any other information on results incl. tables

1 animal of the test group was sacrificed prior to first challenge as it suffered from a broken leg due to being trapped in the cage floor.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, 2.5% Vetyvert Bourbon induced only little and mild skin reactions at all four challenges. A maximum sensitisation rate of 22.2% was calculated for the first readings at the second (rechallenge) and third challenge. The control groups did not show any positive skin reactions. Based on these results the substance does not need to be classified as a sensitiser based on the criteria outline in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
Executive summary:

This guinea pig maximisation test (GPMT) was performed to study the sensitising potential of Vetyvert Bourbon. The methods used resemble those outlined in OECD 406, except for the control groups used. Both an untreated (no induction, only challenge similar to test group) and treated (induction - without test substance - and challenge similar to test group) control group was included. Test group contained 10 animals, control groups contained 4 (different) animals per challenge. Challenges were performed with 2.5% Vetyvert Bourbon in ethanol.

1 animal was sacrificed prior to first challenge as it suffered from a broken leg due to being trapped in the cage floor. No positive skin reactions were observed in any of the controls at all of the four challenges. At first challenge, no positive skin response were observed in the test group (at both readings). At second (rechallenge) and third challenge, 2 and 1 out of 9 animals showed positive reactions at the 24 hour and 48 hour readings, respectively. At fourth challenge, at both readings 1 out of 9 animals showed a positive skin reaction.

Under the conditions of this study, 2.5% Vetyvert Bourbon induced only little and mild skin reactions at all four challenges. A maximum sensitisation rate of 22.2% was calculated for the first readings at the second (rechallenge) and third challenge. The control groups did not show any positive skin reactions. Based on these results the substance does not need to be classified as a sensitiser based on the criteria outline in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.