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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: in compliance with Federal Hazardous Substances Act 16 CFR 1500
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.5
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
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
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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Remarks on result:
other: unabraded skin
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.