Pentadecane, 7-methylene-

Skin sensitisation

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: see 'Remark'

Remarks:

The original study is classified as reliable without restriction because the study was carried out according to OECD Guidelines and was GLP compliant. For the purposes of this use it is rated as reliable with restrictions since it is being used for read across purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

Hexadec-1-ene

EC Number:

211-105-8

EC Name:

Hexadec-1-ene

Cas Number:

629-73-2

IUPAC Name:

hexadec-1-ene

Details on test material:

- Name of test material (as cited in study report): Neodene 16 Alpha Olefin (TMID)
- Physical state: Clear, colourless liquid
- Storage condition of test material: Stored at room temperature, clear glass bottle with black plastic lid.
- Lot/batch No.: WRC Tox/1173
- Molecular formula (if other than submission substance): C16H32
- Molecular weight (if other than submission substance): 224.45
- Smiles notation (if other than submission substance): CCCCCCCCCCCCCCC=C
- InChl (if other than submission substance): InChI=1S/C16H32/c1-3-5-7-9-11-13-15-16-14-12-10-8-6-4-2/h3H,1,4-16H2,2H3

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc.
- Housing: Individually in wire mesh cages
-Weight: 332 to 528 grams
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Four days of quarantine
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: acetone

Induction 2

Concentration / amount:

Primary Irritation (Pilot group): Undiluted, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%
Induction (test group): 10%
Challenge: 2.5%(test group), 2.5% naive control group

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: acetone

Challenge 2

Concentration / amount:

Primary Irritation (Pilot group): Undiluted, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%
Induction (test group): 10%
Challenge: 2.5%(test group), 2.5% naive control group

No. of animals per dose:

Primary: 4 male and 4 female
Test: 10 male and 10 female
Naive Control: 5 male and 5 female
Total Animals: 38

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours each exposure
-Test groups: 10 animals
- Site: Shoulder
- Frequency of applications: Once a week for two weeks
- Concentrations: 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 4 hours
- Test groups: 10 animals
- Control group: 10 naive animals
- Site: Varied but not the same site as the induction phase.
- Concentrations: 2.5%

Positive control substance(s):

yes

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

3

Total no. in group:

20

Clinical observations:

Mean score was 0.1; each of three animals with reactions had individual scores of 0.5

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: Mean score was 0.1; each of three animals with reactions had individual scores of 0.5 .

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

2

Total no. in group:

20

Clinical observations:

Mean score was 0.05; each of the two animals with reactions had individual scores of 0.5

Remarks on result:

other: see Remark

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Mean score was 0.05; each of the two animals with reactions had individual scores of 0.5.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Hexadec-1-ene was found to be not sensitising. The mean severity scores at 24-hour and 48-hour time points were 0.1 and 0.05 for test animals and 0.3 and 0.2 for naïve (un-induced) controls, respectively.

Executive summary:

In a dermal sensitization study using hexadec-1 -ene in acetone, 38 (male and female), young adult Hartley guinea pigs were tested using the method of Buehler.The compound was applied at induction at 10% (w/v) in acetone, and at challenge at a concentration of 0.25% (w/v) in acetone based on the results of a primary irritation test. Effects induced by challenge were reported based on a numerical scoring system and averaged over the total number of animals tested. Appropriate numbers and sexes of animals were evaluated; statistical methods were not used, and were not appropriate for the study. Both sensitivity data and body weight gain were measured. The test compound did not induce hypersensitivity and body weight gain was also unaffected. Hexadec-1 -ene was found to be not sensitising. The mean severity scores at 24-hour and 48-hour time points were 0.1 and 0.05 for test animals and 0.3 and 0.2 for naïve (uninduced) controls, respectively. This result can be considered representative of the likely sensitisation potential of the isomer 7 -methylenepentadecane.