Registration Dossier

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:
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 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: Mean rat weight: Male - 325 g; Female - 213 g
- Fasting period before study: not reported
- Housing: housed individually in solid-bottom caging with bedding and appropriate species-specific enrichment
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6-day quarantine period


ENVIRONMENTAL CONDITIONS
- Temperature: 20-26ºC
- Humidity: 30-70%
- Photoperiod: approximate 12-hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: The paste was spread evenly, directly on the skin, covering an area of approximately 37 square centimetres.
- % coverage: Thirty-seven square centimeters is equal to approximately 10 percent of the total body surface area of rats in the 200 - 300 g body weight range.
- Type of wrap if used: The test substance was covered with a 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Approximately 24 hours after treatment,

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test substance was measured for each animal on the day of treatment at a dose of 5000 mg/kg of body weight. The amount of test substance designated for each animal was calculated based on body weights collected prior to treatment.
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): The aliquot of test substance designated for an animal was moistened with approximately 1 mL of deionized water to form a thick paste.
Duration of exposure:
Approximately 24 hours
Doses:
1
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, and abnormal behaviour. The rats were weighed on test days 1, 8, and 15, and were observed daily for clinical signs of toxicity and dermal irritation (weekends and holidays excluded for dermal irritation)
- Other examinations performed: All rats were euthanized at the end of the 15-day test period and examined to detect grossly observable evidence of organ or tissue damage.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no instances of mortality at 5000 mg/kg.
Clinical signs:
There were no clinical abnormalities or other signs of skin irritation.
Body weight:
There were no overall body weight losses
Gross pathology:
No gross lesions were present in the rats at necropsy.

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).
LD50 > 5000 mg/kg
Executive summary:

A single dose of the test item was applied to the shaved, intact skin of 5 male and 5 female rats at a dose level of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage at the end of the 15-day test period.

There were no incidents of mortality, no overall body weight losses, and no clinical abnormalities or other signs of skin irritation observed during the study. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the dermal LD50 for the test item was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.