Reaction mass of 3-O-acetyl-1,5-anhydro-4-butyl-2,4-dideoxy-2-methyl-D-xylitol and (2R,3S)-2-methyloctane-1,3-diyl diacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Remarks:

Isolated Chicken Eye Test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-04-08 till 2015-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This information is used for read across to Jessemal.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Remarks:

TNO Triskelion, Utrechtseweg 48, 3700 AV, Zeist

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Test material form:

liquid

Test animals / tissue source

Species:

other: eyes of male or female chickens (ROSS, spring chickens)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Slaughterhouse v.d. Bor, Nijkerkerveen, The Netherlands
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: approximately 1.5 - 2.5 kg
- Heads of the animals were cut off immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station on the process line. The heads were placed in small plastic boxes on a bedding of paper tissues moistened with isotonic saline. Next they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.
- The preparation and validation of the eyes prior to the ICE-test were all according to OECD guideline 438.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 30 µL

Duration of treatment / exposure:

10 seconds

Observation period (in vivo):

0, 30, 75, 120, 180, and 240 minutes

Number of animals or in vitro replicates:

3 eyes

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were rinsed with 20 mL saline
- Time after start of exposure: 10 seconds

SCORING SYSTEM: According to OECD 438 guideline.

TOOL USED TO ASSESS SCORE: All examinations were carried out with the hand-slit lamp microscope. Fluorescein retention was only scored at approximately 30 minutes after treatment.

CONTROLS: A negative control (30 µL physiological saline) and 3 positive controls (30 µL Benzalkonium Chloride 5%) were included.

Results and discussion

In vitro

Results

Remarks on result:

other: See description of results under Other effects / acceptance of results'

Other effects / acceptance of results:

CORNEA OPACITY SCORE:
- Swelling score: 3 (maximum value during the test); after 3 hours
- Opacity score: 0.8 of 4 (maximum value during the test); after 2, 3 and 4 hours
- Fluorescein retention score: 0.5 of 3

Applicant's summary and conclusion

Interpretation of results:

other: Not eye irritating

Remarks:

EU CLP (EC No. 1272/2008 and its amendments)

Conclusions:

The test substance caused very slight corneal swelling (3%), very slight or slight to moderate opacity (mean score of 0.8) and very slight fluorescein retention (mean score of 0.5). Microscopic examination of the corneas treated with the test substance did not reveal any abnormalities. Based on these results test substance is not considered to be an eye irritant.

Executive summary:

In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL Benzalkonium Chloride (BAC)) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The scores in this test can be used for eye irritation with severe damage and for severe eye irritation based on an internal validation scheme. The test substance caused very slight corneal swelling (3%), very slight or slight to moderate opacity (mean score of 0.8) and very slight fluorescein retention (mean score of 0.5). Microscopic examination of the corneas treated with the test substance did not reveal any abnormalities. The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. The positive control BAC 5% caused slight erosion, slight or moderate vacuolation (low region) of the epithelium, and the epithelium partly detached from the basement membrane (one cornea). Based on these results test substance is not considered to be an eye irritant.