Ammonium salts of mono- and bis[3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl and/or poly (substituted alkene)] phosphate

Skin irritation / corrosion

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Purity: not reported as such

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2491, 2520, 2742 g
- Housing: singly in suspended stainless steel cages with mesh floors. Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Diet (e.g. ad libitum): ad libitum, Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum, filtered tap water
- Acclimation period: 6 or 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 56-68%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours.

Observation period:

Immediately following patch removal and at approximately 30-60 minutes and 24, 48, and 72 hours after patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100%
- Type of wrap if used: The dose site was covered with a 1-inch x 1 inch, 4-ply gauze pad. The pad and entire trunk of each rabbit was wrapped with semi-occlusive tape. Elizabethan collars were placed on each rabbit.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance removed and the test sites gently cleansed of any residual test substance.
- Time after start of exposure: After 4 hours of exposure.

SCORING SYSTEM: Draize scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: calculated from the 24-, 48-, and 72-hour scores

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: calculated from the 24-, 48-, and 72-hour scores

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no edema noted at any treated dose site during the study. Immediately following patch removal, very slight erythema was noted for two of three treated dose sites. Both animals were free from dermal irritation within 30-60 minutes. No clinical signs of toxicity were observed in any of the rabbits during the study and no body weight loss occurred. The dermal scores from individual animals with respect to observation time are presented in Table 1.

Any other information on results incl. tables

Table 1: Individual Skin Irritation Scores; Erythema/Edema

		Time After patch Removal
Animal No.	Sex	Immediately after patch removal	30-60 mins	24 hrs	48 hrs	72 hrs
3501	F	1/0	0/0	0/0	0/0	0/0
3502	M	0/0	0/0	0/0	0/0	0/0
3503	M	1/0	0/0	0/0	0/0	0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There was no edema noted at any treated dose site during the study. Immediately following patch removal, very slight erythema was noted for two of three treated dose sites. Both animals were free from dermal irritation within 30-60 minutes.

Executive summary:

The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4-hours. Five-tenths of a millilitre of the test substance was applied to the skin of one healthy rabbit for 4-hours. The dose site was evaluated for dermal irritation by the method of Draize et al immediately following patch removal, and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since dermal irritation cleared within one hour in this animal, the test was completed on two additional animals. There was no edema noted at any treated dose site during the study. Immediately following patch removal, very slight erythema was noted for two of three treated dose sites. Both animals were free from dermal irritation within 30-60 minutes.