Ammonium difluoro[1,1,2,2-tetrafluoro-2-(pentafluoroethoxy)ethoxy]acetate

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

Gotemba laboratory, Bozo Research Center Inc

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Perfluoro-3,6-dioxaoctanoic acid ammonium salt (EEA-NH4)
- Physical state: white powder
- Purity: 99%
- Lot/batch No.: #0709211
- Storage condition of test material: in an air tight container (shielded from light) in a cold dark place (measured temperature: 4 to 7 °C)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Atsugi breeding center, Charles River Japan
- Age at study initiation: 7 weeks
- Weight at study initiation: 256 - 281 g for males, 203 to 234 g for females
- Fasting period before study:
- Housing: Bracket type stainless steel wire mesh cages (Lead Engineering Co Ltd.)
- Diet (e.g. ad libitum): Free access to pelleted diet CRF-1
- Water (e.g. ad libitum): Free access to tap water (Gotemba city water) via water bottles
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 42 cm2
- Type of wrap if used: Lint sheet (6 x 7 cm) covered with and fixed by elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with warm water and absorbent gauze
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 500 mg / ml
- Constant volume or concentration used: yes
- For solids, paste formed: No

Duration of exposure:

24 hours

Doses:

500 mg/kg bw, 1000 mg/kg bw and 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 5 mins, 15mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, thereafter daily to 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not performed

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths at highest dose used in study

Mortality:

No deaths occurred.

Clinical signs:

other: There were no abnormal clinical signs in any animal of either sex in either the control group, the test article groups or the control article group during the observation period. Skin irritation reactions, such as erythema, eschar and edema, were not obse

Gross pathology:

There were no abnormal macroscopic findings in the external appearance including the application site or the cranial, thoracic or abdominal organs / tissues in any animal in either sex in the test article groups, the control article group or the control group.