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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
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.
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 the time of study conduct.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to guideline
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
EC Number:
252-046-8
EC Name:
Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
Cas Number:
34455-29-3
Molecular formula:
C15H19F13N2O4S
IUPAC Name:
carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
Details on test material:
-Purity: 87%

Test animals

Species:
rabbit
Strain:
other: New Zealand albino.
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2576-2706 g
- Housing: singly housed in suspended stainless steel caging
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum
- Acclimation period: 6 or 13 days


ENVIRONMENTAL CONDITIONS
- Temperature: 19-22ºC
- Humidity: 40-50%
- Air changes (per hr): 12
- Photoperiod: 12-hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance (0.59 g of the test mixture)

VEHICLE
- Amount(s) applied (volume or weight with unit): dry paste containing 85% test substance and15% distilled water by weight

Duration of treatment / exposure:
4 hours
Observation period:
immediately following patch removal (initial rabbit only) and at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: a 1-inch x 1-inch, 4-ply gauze pad and wrapped with semi-occlusive 3-inch Micropore tape

REMOVAL OF TEST SUBSTANCE
After 4 hours of exposure to the test substance, the pads and collars were removed and the test sites were gently cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4

Any other information on results incl. tables

All animals appeared active and healthy and gained body weight during the study. There was no dermal irritation noted for any treated site during this study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
No skin irritation was observed throughout the study.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application in accordance with OECD guideline 404. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of three healthy rabbits for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal.

There was no dermal irritation noted for any treated site during this study.