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Toxicological information

Acute Toxicity: dermal

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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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Remarks:
Gotemba laboratory, Bozo Research Center Inc
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 observed at the application site.
Body weight:
All males and females in the test article groups and the control article group showed similar bodyweight development to that of the control group and there were no test article or control article related effects.
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.

Applicant's summary and conclusion