Amphoteric Fluorinated Surfactant

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:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Purity: 28 wt%

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:

animal #1

Time point:

other: mean of the 24-, 48-, and 72-hour dermal responses

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean of the 24-, 48-, and 72-hour dermal responses

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean of the 24-, 48-, and 72-hour dermal responses

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean of the 24-, 48-, and 72-hour dermal responses

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean of the 24-, 48-, and 72-hour dermal responses

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean of the 24-, 48-, and 72-hour dermal responses

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no edema noted at any treated dose site during the study. Erythema (score of 1) was noted at the treated site of all three rabbits immediately following patch removal and/or at the 30-60 minute scoring interval. All animals appeared active and healthy and gained body weight during the study. Apart from the dermal irritation, there were no other clinical signs observed. 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	M	0/0	1/0	0/0	0/0	0/0
3502	M	1/0	0/0	0/0	0/0	0/0
3503	M	1/0	1/0	0/0	0/0	0/0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Classification not required Criteria used for interpretation of results: other: Directive 67/548/EEC

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
There was no edema noted at any treated dose site during the study. There was no edema observed at any treated dose during the study. Erythema (score of 1) was noted at the treated site of all three rabbits immediately following patch removal and/or at the 30-60 minute scoring interval. In accordance with the provisions of Directive 67/548/EEC, classification by the dermal route is not required based on the results of this study. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.

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 a.l immediately following patch removal, and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since irritation cleared by 24 hours and there was no significant dermal irritation noted at the dose site of this animal, the test was completed on two additional animals. There was no edema noted at any treated dose site during the study. Erythema (score of 1) was noted at the treated site of all three rabbits immediately following patch removal and/or at the 30-60 minute scoring interval.