Reaction mass of 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper and Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (dimethylamino)methyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 April 2016 - 11 April 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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)

Version / remarks:

Due to unscheduled delay of reporting (The Study was on hold for Sponsor’s request),
the Draft Report was issued later than indicated in the Study Plan. The purity reported is different to the Study Plan due to a new Certificate of Analysis being provided by the
sponsor.

Deviations:

yes

Remarks:

has no impact on the results or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2λ⁵,11,20,29,38,39λ⁵,40,41-octaaza-1-cupradodecacyclo[19.17.1.1¹,¹².1³,³⁷.0²,¹⁰.0⁴,⁹.0¹³,¹⁸.0²²,²⁷.0²⁸,³⁹.0³⁰,³⁸.0³¹,³⁶.0¹⁹,⁴¹]hentetraconta-2,4,6,8,10,12,14,16,18,20,22,24,26,28(39),29,31,33,35,37(40)-nonadecaene-2,39-bis(ylium)-1,1-diuide

EC Number:

908-081-2

IUPAC Name:

2λ⁵,11,20,29,38,39λ⁵,40,41-octaaza-1-cupradodecacyclo[19.17.1.1¹,¹².1³,³⁷.0²,¹⁰.0⁴,⁹.0¹³,¹⁸.0²²,²⁷.0²⁸,³⁹.0³⁰,³⁸.0³¹,³⁶.0¹⁹,⁴¹]hentetraconta-2,4,6,8,10,12,14,16,18,20,22,24,26,28(39),29,31,33,35,37(40)-nonadecaene-2,39-bis(ylium)-1,1-diuide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch number: 150205
Description: Blue powder
Expiry date: 05 February 2019
Purity: As a UVCB, purity is considered as 100%
Storage conditions: Controlled room temperature (15-25°C, below 70% RH%).

Test animals / tissue source

Species:

chicken

Strain:

other: ROSS 308

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: commercial abattoir
- Age at study initiation: approximately 7 weeks old
- Acclimatisation: approximately 45 to 60 minutes.

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg

Duration of treatment / exposure:

10 seconds

Observation period (in vivo):

30, 75, 120, 180 and 240 minutes after the post-treatment rinse

Duration of post- treatment incubation (in vitro):

Observation: 30, 75, 120, 180 and 240 minutes after the post-treatment rinse

Details on study design:

SELECTION AND PREPARATION OF ISOLATED EYES
If the cornea was in good condition, the eyeball was carefully removed from the orbit.

EQUILIBRATION AND BASELINE RECORDINGS
The cornea thickness of the eyes should not change by more than 5% within the -45 min and the zero time.

NEGATIVE CONTROL USED: Physiological saline solution (0.9% (w/v) NaCl)

POSITIVE CONTROL USED: Imidazole

OBSERVATION PERIOD: 30, 75, 120, 180 and 240 minutes after the post-treatment rinse

REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: 20 mL in physiological saline at ambient temperature. Additional gentle rinsing with 20 mL saline was performed at each time point when the test item or control material remaining on the cornea was observed.

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: yes
- Damage to epithelium based on fluorescein retention:yes
- Swelling: measured with optical pachymeter on a slit-lamp microscope
- Macroscopic morphological damage to the surface: yes

SCORING SYSTEM:
- Mean corneal swelling (%)
- Mean maximum opacity score
- Mean fluorescein retention score at 30 minutes post-treatment

DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used: based on the OECD guideline quantitative assessments

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

mean maximum

Run / experiment:

1

Value:

0.67

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

fluorescein retention score

Remarks:

mean retention

Run / experiment:

1

Value:

1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

percent corneal swelling

Remarks:

mean maximum up to 75 min

Run / experiment:

1

Value:

0.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

percent corneal swelling

Remarks:

Mean maximum up to 240 min

Run / experiment:

1

Value:

1.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Test item was stuck on all cornea surfaces during the full the post-treatment period and could not be rinsed off. All three cornea surfaces were not cleared at 240 minutes after the post-treatment rinse. The particles stuck to the cornea could mask corneal effects underneath the particles and could potentially result in mechanical damage in vivo.
The results from all eyes used met the quality control standards. The negative control and positive control results were in line with historic data. This experiment was considered to be valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is not classified as a severe irritant and not classified as non-irritant.
It is concluded that an in vivo study is required for proper classification.