Registration Dossier

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:
2003-05-22 to 2003-05-25
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid
Details on test material:
Bernel Ester TCC (Tricapryl Citrate), Lot #P1585
Colourless lliquid stored at room temperature
100%. Test substance was expected to be stable for the duration of testing

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
New Zealand Albino, one male 2 female young adults. They were housed singly. Temperature 20-22 C with 12/12 hour light/dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL to 6cm2 per animal
Duration of treatment / exposure:
After 4 hours the pads and collars were removed and the test sites cleansed of any residue substance
Observation period:
1, 24, 48 and 72 hours after removal of patch
Number of animals:
3
Details on study design:
Individual dose sites were scored according to the Draize scoring system. The classification of irritancy was obtained by adding the average erythema and edema scores for the 1, 24, 48 and 72-hour scoring intervals and dividing by the number of evaluation intervals (4). The resulting Primary Dermal Irritation Index (PDII) was classified as follows:
0 - Non-irritiating
>0-2.0 - Slightly irritating
2.1-5.0 - Moderately irritating
>5.0 - Severely irritating

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1
Score:
1
Max. score:
1
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24
Score:
1
Max. score:
1
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
1
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
1
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1
Score:
0
Max. score:
1
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
1
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
1
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
1
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Primary Dermal Irritation Index
Conclusions:
Under the conditions of this study, the test substance is classified as slightly irrritating to the skin.
Executive summary:

3 New Zealand Albino rabbits had 0.5mL of the test substance topically applied to a clipped 6cm2 area of skin which was then covered semi-occlusively for 4 hours. No edema was noted for any treated site during the study.

At one and 24 hours after the patch removal slight erythema was evident at all 3 treated sites in all animals. All animals were free from dermal irritation at 48 hours. The Primary Dermal Irritation Index was 0.5. Under the conditions of this study, the test substance is classified as slightly irrritating to the skin.