Reaction products of disodium hydroxysubstitutedpolycycledisulphonate reacted with 2,4,6-trichloro-1,3,5-triazine, subsequently coupled with diazotized 2-[(p-substitutedphenyl)sulphonyl]ethyl hydrogen sulphate, subsequently reacted with disodium hydroxysubstitutedpolycycledisulphonate and subsequently coupled with diazotized disodium substitutedpolycycledisulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

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)

Version / remarks:

25 June 2018

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)

Version / remarks:

08 December 2010

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

chicken

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

30 mg

Duration of treatment / exposure:

10 seconds

Duration of post- treatment incubation (in vitro):

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

Number of animals or in vitro replicates:

3 enucleated chicken eyes

Details on study design:

The endpoints evaluated were corneal opacity, swelling, fluorescein retention, and morphological
effects (e.g., pitting or loosening of the epithelium). All of the endpoints, with the exception of
fluorescein retention (which was determined only at pretreatment and 30 minutes after test item
exposure) were determined at each of the above time points.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

3

Value:

0

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

fluorescein retention score

Run / experiment:

3

Value:

3

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

percent corneal swelling

Run / experiment:

3

Value:

1

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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 Red STR 172 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) are required to establish a definitive classification.