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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:
2012
Report date:
2012

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:
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:
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.
GLP compliance:
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 methacrylate
Details on test material:
-Purity: 99.7%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of untreated skin were used for comparison.
Duration of treatment / exposure:
4 hours
Observation period:
3 minutes, and 1, 24, and 72 hours after test substance removal
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: range of means for 3 animals
Time point:
other: 1 hour to 72 hours
Score:
0.3 - 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
other: range of means for 3 animals
Time point:
other: 1 hour to 72 hours
Score:
0 - 0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Other effects:
Four hours exposure to 0.5 mL of the test item resulted in very slight or well-defined erythema and very slight or well-defined oedema in the treated skin areas of the three rabbits. The skin irritation had resolved within 48 hours after exposure in two animals and within 72 hours in the other animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Very slight or well-defined erythema and very slight or well-defined oedema was observed. The skin irritation had resolved within 72 hours.
Executive summary:

The test substance was evaluated for acute skin irritation potential in 3 New Zealand White rabbits. The test sites were covered with a semi-occlusive dressing to ensure contact between the skin and test substance. The animals were exposed to the test substance for 4 hours. The test sites were evaluated and scored according to a numerical scale, 1, 24, and 72 hours after the end of the 4-hour exposure period.  Exposure to the test substance resulted in very slight or well-defined erythema and very slight or well-defined oedema in the treated skin areas of the three rabbits. The skin irritation had resolved within 48 hours after exposure in two animals and within 72 hours in the other animal.

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