Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 April 2006 to 03 May 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Guideline-conform study conducted under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1992)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1987)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

EC Number:

500-537-5

EC Name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Cas Number:

161075-00-9

Molecular formula:

R-O(C3F6O)m-R with R= - CF3, - C2F5, -CF2H

IUPAC Name:

1,1,1,2,3,3-hexafluoro-2,3-bis(1,1,2,2,2-pentafluoroethoxy)propane; 1,1,1,2,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)-3-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)-2-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-{[1,1,1,2,3,3-hexafluoro-3-(trifluoromethoxy)propan-2-yl]oxy}-2-(trifluoromethoxy)propane; 1,1,1,3,3,4,6,6,7,9,9,10,12,12,12-pentadecafluoro-4,7,10-tris(trifluoromethyl)-2,5,8,11-tetraoxadodecane; 1-(difluoromethoxy)-1,1,2,3,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)propane; 2,2,3,5,5,6-hexafluoro-3,6-bis(trifluoromethyl)-1,4-dioxane; 2-(difluoromethoxy)-1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)propane

Details on test material:

- Name of test material (as cited in study report): GALDEN HT 70
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: > 99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 3816 OE
- Expiration date of the lot/batch: 31 December 2015
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: at room temperature (20°C +- 5), light protected.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: livestock farming
- Age at study initiation: males: 8 weeks, females: 12 weeks
- Weight at study initiation: Males: 230-247 g; Females: 190-204 g
- Fasting period before study: not reported
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. During treatment and observation in Makrolon type-3 cages with standard softwood bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light cycle

IN-LIFE DATES: From: To: not reported

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
One days before the treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only animals without injury or irritation on the skin were used in the test.
On test day1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hour

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.2 ml/Kg bw (corrisponding to 2000 mg/Kg bw)
- Concentration (if solution): n.a. The test material was applied unchanged.
- Constant volume or concentration used: yes
- For solids, paste formed: n.a.

VEHICLE
- Amount(s) applied (volume or weight with unit): n.a.
- Concentration (if solution): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 (5 males + 5 females)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability was checked daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weight was recorded on test day 1 (prior to administration), 8 and 15. Animals were examined for clinical signs daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Animals were examined for local signs once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, local signs, body weight, macroscopic examinations at necropsy.

Statistics:

no statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic or local signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of GALDEN LMW after single dermal administration to rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg body weight.

Executive summary:

The purpose of this study was to assess the acute dermal toxicity of GALDEN LMW when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days.

Five male and five female HanRcc:WIST (SPF) rats were treated with GALDEN LMW at 2000mg/kg by dermal application. The test item was applied undiluted as delivered from the sponsor at a volume dosage 1.2 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recordered. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2 -15. Local signs were recorded once daily from test day 2 to 15. Mortality/viability was recordered at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 -15. Body weights were recordered on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed during the course of the study. The body weights of the animals was within the range commonly recordered for this strain and age. No macroscopic findings were observed at necropsy. In conclusion the median lethal dose of GALDEN LMW after single dermal administration to rats of both sexes, observed over a period of 14 days is LD50 (rat) greater than 2000 mg/kg body weight.