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Toxicological information

Skin irritation / corrosion

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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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
Kannami Laboratory, Bozo Research Center Inc

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
- Analytical purity: 99%
- Lot/batch No.: #070921
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Japanese white
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan Laboratory animals inc
- Age at study initiation: 17 or 18 weeks
- Weight at study initiation: 3.16 - 3.59 kg
- Housing: Aluminium cages (Nihon Cage Co Ltd) with wire mesh bottoms
- Diet (e.g. ad libitum): Free access to RC4 pelleted dies
- Water (e.g. ad libitum): Free access to tap water (Fujimi Water Union) via automatic water supply system
- Acclimation period: 12 - 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24°C
- Humidity (%): 50 - 76%
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
3 minutes to 4 hours
Observation period:
up to 6 days
Number of animals:
3
Details on study design:
In this study 0.5 g of the test substance was applied to a lint sheet (2.5 x 2.5 cm) and moistened by 0.5 ml of water for injection and then it was applied to the clipped dorsal skin of rabbits for 3 minutes, 1 hour or 4 hours. Animals were observed periodically for dermal reactions including the corrosion reactions according to the Draize method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal: 1101, 1102 and 1103
Time point:
other: 24, 48 and 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: 1101, 1102 and 1103
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no edema observed through observation period
Other effects:
None observed.

Applicant's summary and conclusion