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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

eye irritation: in vivo
Type of information:
other: Read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not specified
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference Type:
Final Report on the Safety Assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid and Stearic Acid
Libert M.A.
Bibliographic source:
Journal of the American College of Toxicology

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The test item was administered to the eyes of six albino rabbits. 0.1 mL of test item was instilled into one eye of each test animals (untreated eye was used as control). The treated eyes were not rinsed after the application of the test item. Effects to the cornea, iris and conjunctivae were observed up to 72 hrs.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:

Test animals / tissue source

other: albino rabbits
Details on test animals or tissues and environmental conditions:
Not specified

Test system

unchanged (no vehicle)
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of the commercially grade test item.
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Irritation parameter:
overall irritation score
Time point:
72 h
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: Not eye irritant according to CLP Regulation (EC) 1272/2008
Administration of commercial grade test item to the eyes of 6 albino rabbits produced no irritation.
Executive summary:

The eye irritation potential of the test item was studied in an in vivo test on albino rabbits. 0.1 mL of the test item (commercially grade) was administered to the eye of six albino rabbits (untreated eye was used as control). The treated eyes were not rinsed after the application of the test item. No sign of irritation were observed after the application of the test item, so it was considered as non irritant.