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Toxicological information

Acute Toxicity: dermal

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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:
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:
2009
Report date:
2009

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 guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes
Test type:
other: Single-dose acute dermal
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate
EC Number:
218-407-9
EC Name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate
Cas Number:
2144-53-8
Molecular formula:
C12H9F13O2
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methylprop-2-enoate
Details on test material:
- Purity: 97.57%

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 10 weeks
- Weight at study initiation: Average of 398.38 grams for males; 219.68 grams for females
- Fasting period before study: Not reported
- Housing: Singly in polycarbonate pans that contained bedding and enrichment (e.g., nestlet or nylabone)
- Diet (e.g. ad libitum): ad libitum (PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal area and trunk.
- % coverage: approximately 5 cm x 7.4 cm, approximately 10% of the body surface
- Type of wrap if used: 2-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with stretch gauze bandage and self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were gently washed with warm water.
- Time after start of exposure: After 24 hours of exposure to the test substance.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight.
- Constant volume or concentration used: yes
Duration of exposure:
Animals were exposed to the test substance for 24 hours. Animals were observed for 14 days following application.
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body Weights – Individual body weights were recorded prior to test substance application (test day 0), and on test days 7 and 14.
Clinical Observations – Animals were observed for clinical signs of toxicity and dermal response at the time of test substance removal. Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study.
- Necropsy of survivors performed: Yes
Statistics:
No.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities occurred. All animals survived exposure to the test substance.
Clinical signs:
No clinical signs of systemic toxicity were noted. A wound observed in 1 rat was considered incidental.
Body weight:
No biologically relevant body weight losses were observed.
Gross pathology:
Gross findings were present in 2 of 10 rats. These included ulcer/erosion of untreated skin in one rat and coarse surface on the liver in another rat. No other gross findings were observed.
Other findings:
The rats exhibited no dermal irritation during the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC and Globally Harmonized System (GHS)
Conclusions:
LD50 (rats) > 5000 mg/kg
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose 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. No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or biologically relevant body weight loss. No dermal irritation was observed. Gross findings were present in 2 of 10 rats dosed at 5000 mg/kg. These included ulcer/erosion of untreated skin in one rat and coarse surface on the liver in another rat. No other gross findings were observed. Under the conditions of this study, the dermal LD50 for the test substance was greater than 5000 mg/kg for male and female rats.