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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: 244-259 g (males); 166-188 g (females)
- Fasting period before study: no
- Housing: individually housed in labeled Macrolon cages (Mill type, height 18 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten, GbmH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.6
- Humidity (%): 31-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm2 (males); 18 cm2 (females)
- % coverage: 10
- Type of wrap if used: Surgical gauze patch (Surgy 1D), covered with aluminum foil and Coban elastic bandange. Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 1.287 mL/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at periodic intervals on the day of dosing (day 1), and once daily thereafter until day 15; weighing on day 1, 8, 15 and at death
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male was found dead on day 2. No further mortality occurred.

Clinical signs:

other: The males showed hunched posture, ptosis, chromodacryorrhea and/or flat posture on days 1 and 2. Two females showed chromodacryorrhea on days 1 and/or 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

Scabs were seen in the treated skin-area of one male during the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of AC-6000 in Wistar rats is >2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity study was conducted in accordance with OECD 402 (Acute Dermal Toxicity), EU Method B.3 (Acute Toxicity (Dermal)), and EPA OPPTS 870.1200 (Acute Dermal Toxicity) guidelines. AC-6000 was applied dermally to male and female Wistar rats. The test substance was held in place for 24 hrs to an area approximately 10% of the total body surface, after which dressings were removed and residual test substance washed off with tap water. One male was found dead on Day 2. No further mortality occurred. On Days 1 and/or 2 males showed hunched posture, ptosis, chromodacyorrhea and/or flat posture, and two females showed chromodacryorrhea. One male had scabs on the treated skin-area. Changes in body weight were within the range expected for rats used in this type of study, and were not considered indicative of toxicity. There were no macroscopic abnormalities found at necropsy. Therefore, the dermal LD50 of AC-6000 in Wistar rats is >2000 mg/kg body weight.