Pentadecane, 7-methylene-, mixed with 1-tetradecene, dimers and trimers, hydrogenated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Full GLP study available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: in compliance with Federal Hazardous Substances Act 16 CFR 1500

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No results reported at 48 hour timepoint

GLP compliance:

yes

Remarks:

US regulation 21CFR58

Test material

Test material information

Constituent 1

Reference substance name:

68037-0-14

IUPAC Name:

68037-0-14

Constituent 2

Reference substance name:

1-decene, homopolymer, hydrogenated

IUPAC Name:

1-decene, homopolymer, hydrogenated

Constituent 3

Reference substance name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

EC Number:

500-183-1

EC Name:

Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated

IUPAC Name:

500-183-1

Details on test material:

- Name of test material (as cited in study report): Emery 3006
- Molecular formula (if other than submission substance): C10 polyalphaolefin (trimer to hexamer oligomer mixture; C30-60.H62-122)
- Molecular weight (if other than submission substance): 552 (weight average), 528 (number average)
- Smiles notation (if other than submission substance): (CCCCCCCCCC) x 3.8 average
- Substance type: hydrogenated polyalphaolefin oligomer
- Lot/batch No.: 8BU27
- Physical state: clear liquid
- Storage condition of test material: room temperature in a metal container with lid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Clerco Research Farms
- Housing: individually in wire mesh cages
- Diet (ad libitum): Purina Rabbit Chow
- Water (ad libitum): tap
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12hr

IN-LIFE DATES: 5-apr-88

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1 sq inch on saddle area of rabbit
- % coverage:
- Type of wrap if used: Gauze pad held in place with adhesive tape. Trunk of rabbit then wrapped with rubber dental dam. Rabbits wore collars.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize (1959) and a primary irritation index calculated (range 0-8, where irritant considered a substance with a PII>5)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

0.5

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hour

Score:

0.83

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: both intact and abraded skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hour

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: both intact and abraded skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

0.17

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: abraded skin

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

0

Remarks on result:

other: unabraded skin

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: both intact and abraded skin

Irritant / corrosive response data:

Data for relevant non abraded skin: Erythema scores are shown in 'remarks' on results field below. Odema results all zero except one rabbit at time 24hrs (score 1). Results for abraded skin varied little

Other effects:

none reported

Any other information on results incl. tables

Erythema scores - intact skin results:

Rabbit	1	2	3	4	5	6
24hrs	2H	0	1	1	1	0
72hrs	0H	0	0H	0	0	0

There was some interference in the scoring by the presence of hair at the test sites. There was no significant difference in the results between abraded and intact skin. These are marked with H above.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance has low irritancy potential

Executive summary:

In a GLP skin irritancy study, rabbits were exposed to a substance similar to "Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated" under occluded conditions for a period of 24 hours. Duplicate experiments were carried out with abraded and intact skin. No odema was seen in any animal. Erythema was observed about two thirds of animals, with one animal in each cohort reaching a level 2 (well defined erythema). No animal showed erythema by the 72 hour observation. The substance tested is a mild skin irritant. The criteria for classification as a skin irritant were not met.