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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 july to 3 october 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
yes
Remarks:
The eyes were incubated between 45 and 64 min instead of 45 and 60 min. As the results obtained with the eyes with the neg control, were conformed to what was expected, the deviation is considered as without impact on the conclusion of the study.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Sage, Salvia lavandulifolia, ext.
EC Number:
290-272-9
EC Name:
Sage, Salvia lavandulifolia, ext.
Cas Number:
90106-49-3
Molecular formula:
no relevant UVCB
IUPAC Name:
Sage, Salvia lavandulifolia, ext.
Test material form:
liquid
Details on test material:
UVCB
Specific details on test material used for the study:
• Sponsor’s identification: SPANISH SAGE OIL (Salvia lavanduliflia)
• CAS No.: 8016-65-7
• Batch No.: LS104585
• Date received: 28 March 2018
• Container: smoked glass flask (n=3)
• Storage: room temperature, darkness
• Quantity (container + content) : 113.20 g + 113.50 g + 114.20 g
• Form: liquid
• Colour: colorless to slight yellow
• Production date: August 2017
• Expiry date: August 2021

Test animals / tissue source

Species:
chicken
Strain:
not specified
Details on test animals or tissues and environmental conditions:
The eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820 Etauliers, France) where they are killed for human consumption have been used for this assay.
The age and weight of the chickens used in this test method are that of spring chickens traditionally processed by a poultry slaughterhouse (i.e., approximately 7 weeks old, 1.5 - 2.5 kg).
Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. The heads have been collected on 23 July 2018 at 8:25 am.
Because eyes were dissected in the laboratory, the intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline.
The eyes were enucleated at Phycher on 23 July 2018 at 8:25 am.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
0.03 mL
Duration of treatment / exposure:
The test item (liquid or solid) is applied for 10 seconds and then rinsed from the eye with physiological saline (approximately 20 mL) at ambient temperature. If the rinse volume exceeds approximately 20 mL, the rinse volume used will be reported.
Observation period (in vivo):
Treated corneas are evaluated prior to treatment and at 30, 75, 120, 180, and 240 minutes (± 5 minutes) after the post-treatment rinse.
Duration of post- treatment incubation (in vitro):
These time points provide an adequate number of measurements over the four-hour post-treatment period, while leaving sufficient time between measurements for the requisite observations to be made for all eyes.
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
eye no 7
Value:
<= 0
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
eye no 8
Value:
<= 0
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Run / experiment:
eye no 9
Value:
<= 0
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
eye no 7
Value:
>= 0.5 - <= 3
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
eye no 8
Value:
>= 0.5 - <= 3
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Run / experiment:
eye no 9
Value:
>= 0.5 - <= 3
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Run / experiment:
eye no 7
Value:
>= 0 - <= 2
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Run / experiment:
eye no 8
Value:
>= 0
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Run / experiment:
eye no 9
Value:
>= 0 - <= 2
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Combinantion of the 3 Endpoints : 1 X IV , 2 X I : no prediction can be made.
No morphological effects were noted, whatever the examination time.

Any other information on results incl. tables

The ocular reactions observed in eyes treated with the test item were:

-  maximal mean score of corneal opacity: 0.0, corresponding to ICE class I;

-  mean score of fluorescein retention: 3.0, corresponding to ICE class IV;

-  maximal mean corneal swelling: 1%, corresponding to ICE class I.

The combination of the three endpoints for the test SPANISH SAGE OIL (Salvia lavandulifolia) was 1 x IV, 2 x I.

The combination of the three endpoints for the positive control, 5% Benzalkonium chloride, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.

The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as “No Category”, as expected.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438.
Therefore, the test item SPANISH SAGE OIL (Salvia lavandulifolia) is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method.
Additional testing (in vitro and/or in vivo) is required to establish a definitive classification.