Thuya plicata, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2016 to february 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

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)

GLP compliance:

yes (incl. QA statement)

Remarks:

see GLP certificate in final report annex 1

Test material

Test material information

Constituent 1

Reference substance name:

Thuya plicata, ext.

EC Number:

305-105-8

EC Name:

Thuya plicata, ext.

Cas Number:

94334-32-4

Molecular formula:

not relevant as a UVCB substance

IUPAC Name:

Water steam distillation of needles and twigs of Thuya plicata

Test material form:

liquid

Specific details on test material used for the study:

batch No : SNPM N°4425
code No (lab) : PH-16/0604
container : glass flask (n=1)
production date : 10 october 2016
expiry date : 10 october 2019

Test animals / tissue source

Species:

chicken

Strain:

not specified

Details on test animals or tissues and environmental conditions:

The age and weight of the chickens used in this test methodare that of spring chickens traditionally processed by a poultry slaghterhouse (ie approx 7 weeks old, 1.5 to 2.5 kg).
Heads have been removed immediately after sedation of thechickens by electric shock. Eyes were transported from the slaughterhouse at ambiant temperature in plastic boxes humidified with towels moistened with physiologic saline. The eyes enucleated at Phycher on 05 December 2016 at 9:30 am.

Test system

Vehicle:

physiological saline

Amount / concentration applied:

30 µL, to 3 enucleated chicken eyes

Duration of treatment / exposure:

during 10 seconds, then eyes were rinsed twice with 10 mL of physiological saline.

Observation period (in vivo):

30, 75, 120, 180, and 240 minutes post-dose

Number of animals or in vitro replicates:

3

Details on study design:

Thre eyes were treated in the same manner with a positive control, and one eye with a negative control.
The ocular reactions observed in eyes treated with the test item were :
- max mean score of corneal opacity
- mean score of fluorescin retention
- max mean corneal swelling

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Value:

3

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Results 2

Irritation parameter:

fluorescein retention score

Value:

3

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Results 3

Irritation parameter:

percent corneal swelling

Value:

1

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

test item not predicted

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 huile essentielle de thuya plicata is not predicted as causing serious eye damage (cat1) or as not classified for eye irritation/serious eye damage (no category) with ICE test method.
Additional testing (in vitro and/or in vivo) are required to establish a definitive classification.