Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane

EC Number:

700-684-7

Cas Number:

80793-17-5

Molecular formula:

C8H5F13

IUPAC Name:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane

Details on test material:

- Name of test material (as cited in study report): 1,1,1,2,2,3,3,4,4,5,5,6,6-Tridecafluorooctane
- Physical state: clear colourless liquid
- Batch number: 070412
- Purity: 99.9%
- Storage condition of test material: at room temperature in the dark
- Stability under storage conditions: stable

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm)
- Diet: Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiäten GmbH, Soest, Germany) approximately 100 grams per day. Hay (Technilab-BMI BV, Someren The Netherlands) was provided at least 3 times a week
- Water: free access to tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4-22.5
- Humidity (%): 39-64
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent areas of the untreated skin of each animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 150 cm2
- Type of wrap if used: metalline patch of 2x3 cm, mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes, using tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: 1 to 3

Time point:

other: 1h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1 to 3

Time point:

other: 1h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal: 1 to 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal: 1 to 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Other effects:

No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There was no evidence of skin irritation or corrosion, no staining of the treated skin, and no symptoms of systemic toxicity were observed after 4 hrs of exposure to AC-6000. Therefore, AC-6000 is not considered irritating/corrosive for the skin.

Executive summary:

An acute dermal irritation GLP study according to OECD guideline 404 was conducted in 3 male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the skin. In this study 0.5 mL of the test substance was applied to the clipped skin of rabbits for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to AC-6000. The mean (24, 48 and 72 hours) scores for erythema and edema were both 0. Based on these results AC-6000 can be regarded as not irritating to skin.