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Diss Factsheets

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
Study period:
24 October - 27 October 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,2-trifluoro-1-{5,8,14-triazatetracyclo[10.3.1.0²,¹¹.0⁴,⁹]hexadeca-2,4,6,8,10-pentaen-14-yl}ethan-1-one
EC Number:
810-682-9
Cas Number:
230615-70-0
Molecular formula:
C15H12F3N3O
IUPAC Name:
2,2,2-trifluoro-1-{5,8,14-triazatetracyclo[10.3.1.0²,¹¹.0⁴,⁹]hexadeca-2,4,6,8,10-pentaen-14-yl}ethan-1-one
Test material form:
solid: particulate/powder
Details on test material:
Buff coloured solid or pale brown powder depending on which batch
Storage conditions: room temperature. in the dark
Specific details on test material used for the study:
Buff coloured solid
Storage conditions: room temperature, in the dark
Batch number: 53650-10-11

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
At the start of the study the animals were in the weight range of 2.47 to 2.94 kg and were twelve to sixteen weeks old. After an acclimatisation period of at least five days each animal was given a unique number. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study. The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
A quantity of 0.5 g of the test material was introduced onto a 2.5 cm x 2.5 cm cotton gauze patch, moistened with 0.5 ml of distilled water and then placed in position on the shorn skin.
Duration of treatment / exposure:
4 hours
Observation period:
Approximately one hour following the removal of the patches, and 24. 48 and 72 hours later. the test sites were examined for evidence of primary irritation.
Number of animals:
3 (1 females and 2 males)
Details on study design:
On the day before the test, three rabbits were clipped free of fur from the dorsal/flank area. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 g of the test material was introduced onto a 2.5 cm x 2.5 cm cotton gauze patch, moistened with 0.5 ml of distilled water and then placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals from interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 60 Male
Time point:
other: 1 hr., 24 hrs., 48 hrs., and 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 61 Female
Time point:
other: 1 hr., 24 hrs., 48 hrs., and 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: 69 Male
Time point:
other: 1 hr., 24 hrs., 48 hrs., and 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 60 Male
Time point:
other: 1 hr., 24 hrs., 48 hrs., and 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 61 Female
Time point:
other: 1 hr., 24 hrs., 48 hrs., and 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 69 Male
Time point:
other: 1 hr., 24 hrs., 48 hrs., and 72 hrs.
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 93/21/EEC and does not meet GHS criteria.