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Diss Factsheets

Toxicological information

Skin sensitisation

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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
Study period:
1995-07-05 to 1995-10-31
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 was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
other: Modified Buehler
Justification for non-LLNA method:
Study was performed before implementation of the LLNA method.

Test material

Constituent 1
Reference substance name:
C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons
EC Number:
700-762-0
Molecular formula:
All molecules present in the mixture have the general molecular formula CnH2n for olefins or CnH2n+2 for the paraffin’s with n being an even number
IUPAC Name:
C14-16 (even numbered) and C16 (branched) saturated and unsaturated aliphatic hydrocarbons
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley, Incorporated, Indianapolis, Indiana
- Age at study initiation: Young adult
- Weight at study initiation: 302 to 380 grams
- Housing: Individual suspended wire-mesh cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71.6 to 72.2 degrees Fahrenheit
- Humidity (%): 39.2 to 47.7%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From:1995-08-03 To: 1995-10-02

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
Primary Irritation Phase: 2.5, 5, 10, 25, 50% tridecene prepared in acetone and 100% Neodene 13
Induction Phase: 100% tridecene
Challenge Phase: 5% tridecene prepared in acetone
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
Primary Irritation Phase: 2.5, 5, 10, 25, 50% tridecene prepared in acetone and 100% Neodene 13
Induction Phase: 100% tridecene
Challenge Phase: 5% tridecene prepared in acetone
No. of animals per dose:
Primary Irritation Phase: 4 male, 4 female
Induction Phase: 10 male, 10 female
Challenge Phase: 10 male , 10 female
Details on study design:
RANGE FINDING TESTS: A primary irritation phase was conducted to determine the concentration used for the induction and challenge phase of the study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 guinea pigs (10 male, 10 female)
- Control group: Positive control group (6 male, 6 female); Naive control group (6 male, 6 female)
- Site: dorsal trunk and flank (3 sites/animal)
- Frequency of applications: Once per week
- Duration: 3 weeks
- Concentrations: 100% tridecene 13 (test group); 0.25% weight/volume DNCB in 80% ethanol (positive control)
- Other : administered at 0.4 mL/site

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Exposure period: 6 hours
- Test groups: 20 guinea pigs (10 male, 10 female)
- Control group: 12 guinea pigs for positive control (6 male, 6 female) and 12 guinea pigs for naive control (6 male and 6 female)
- Site: right flank
- Concentrations: 5% tridecene in acetone
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
Naive and positive control groups were used. The positive control material , dinitrochlorobenzene (DNCB) was prepared for challenge dosing as a 0.1% weight/volume solution in 80% ethanol and administered at 0.4 mL/site.
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene (DNCB)

Results and discussion

Positive control results:
The positive control, dinitrochlorobenzene (DNCB), was demonstrated to be an extreme sensitising agent under the conditions of this study based on a Sensitising Incidence Index of 100%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% tridecene
No. with + reactions:
3
Total no. in group:
12
Clinical observations:
Very slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% tridecene. No with. + reactions: 3.0. Total no. in groups: 12.0. Clinical observations: Very slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% tridecene
No. with + reactions:
2
Total no. in group:
12
Clinical observations:
Very slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% tridecene. No with. + reactions: 2.0. Total no. in groups: 12.0. Clinical observations: Very slight erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% tridecene
No. with + reactions:
3
Total no. in group:
19
Clinical observations:
Very slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% tridecene. No with. + reactions: 3.0. Total no. in groups: 19.0. Clinical observations: Very slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% tridecene
No. with + reactions:
4
Total no. in group:
19
Clinical observations:
Very slight erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% tridecene. No with. + reactions: 4.0. Total no. in groups: 19.0. Clinical observations: Very slight erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% DNCB
No. with + reactions:
12
Total no. in group:
12
Clinical observations:
Moderate to severe erythema and varied levels of oedema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% DNCB. No with. + reactions: 12.0. Total no. in groups: 12.0. Clinical observations: Moderate to severe erythema and varied levels of oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% DNCB
No. with + reactions:
12
Total no. in group:
12
Clinical observations:
Moderate to severe erythema and varied levels of oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% DNCB. No with. + reactions: 12.0. Total no. in groups: 12.0. Clinical observations: Moderate to severe erythema and varied levels of oedema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Tridecene produced a Sensitisation Incidence Index of 0/19 (0%) and is considered not to be a dermal sensitizer to albino guinea pigs.
Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for Category C isomerised olefins using tridecene as an analogue. Tridecene is an isomerised olefin; however, it is not a substance covered under the Higher Olefins and Poly Alpha Olefins Consortium. Therefore, tridecene’s chemical structure, as well as mammalian health endpoints, are comparable to other Category C isomerised olefins. Therefore, read across between tridecene and Category C isomerised olefins can be justified.

In a dermal sensitisation study using tridecene, young adult albino Hartley guinea pigs (10 male, 10 female) were tested using a modified Buehler method. The study utilized three tiers of testing: the primary irritation phase, induction phase, and the challenge phase. The primary irritation phase determined irritation thresholds for tridecene using test dose concentration of 2.5, 5, 10, 25, 50 and 100% tridecene in acetone. The induction phase exposed 20 test animals to tridecene 13 (100%) under occlusion for 6 hours once per week, for 6 hours, for three weeks, for a total of three exposures. To detect sensitisation, animals were administered a topically challenged dose of tridecene (5% prepared in acetone). The challenge dose was administered following a two week rest period after the induction phase. Reactions to the primary, induction and challenge phase were observed 24 to 48 hours after completion of exposure and graded according to the Draize scale. A positive control group (dinitrochlorobenzene) and naïve control group were included for induction and challenge dosing respectively. 

The Sensitisation Incidence Index was used to determine sensitisation. In the primary irritation phase, administration of 5% tridecene induced very slight erythema at 24 and 48 hours post exposure in 3 to 4 animals, respectively. Four animals treated with 100% tridecene 13 showed very slight to slight erythema and oedema reactions at 24 hrs, while slight erythema and 2 very slight oedema reactions were observed in 4 animals at 48 hours. Based on these results, the study authors determined 100% tridecene to be appropriate for the induction phase. A 5% test solution of tridecene in acetone was considered to be the maximal nonirritating concentration and was used for challenge dosing.

Slight erythema was noted in the test group following the challenge dose of 5% tridecene at 24 and 48 hours post-exposure. No incidences of oedema were reported. In the naïve control group, very slight erythema was observed at 24 and 48 hours. The authors reported one animal death from the test group on day 28 prior to challenge dosing which was considered to be isolated and unrelated to the test material. The positive control (DNCB) produced the expected results at challenge.

Based on these study results, the authors calculated a Sensitization Incidence Index to be 0/19 (0%) for the test chemical following the challenge dose administration. The authors concluded that based on the 0% Sensitisation Incidence Index, tridecene was nonsensitising to albino guinea pigs under the testing conditions outlined in the study.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely followed OECD guideline 406 and was GLP compliant. This study will influence the DNEL(s).