Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 438

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

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:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-trichlorobenzene
EC Number:
203-608-6
EC Name:
1,3,5-trichlorobenzene
Cas Number:
108-70-3
Molecular formula:
C6H3Cl3
IUPAC Name:
1,3,5-trichlorobenzene
Test material form:
solid
Details on test material:
• Sponsor’s identification: TCB (1,3,5-trichlorobenzène)
• Batch No.: 171882
• Category: Chemical Substance
• Date received: 17 September 2021
• EINECS No.: 203-608-6
• Container: plastic flask (n=1)
• CAS No : 108-70-3
• Quantity: 101.00 g (container + content + label)
• Form: solid
• Homogeneity: yes • Colour: white
• Production date: not provided
• Expiry date: February 2024
• Storage: room temperature
• Purity: 99,85 %
• Stability: stable under storage conditions
• Composition : 99.85 % 1,3,5-trichlorobenzène

Test animals / tissue source

Species:
chicken
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).

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
fluorescein retention score
Run / experiment:
Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180, and 240 minutes
(± 5 minutes) after the post-treatment rinse.
Value:
1
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
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.
Positive controls validity:
valid
Remarks:
The combination of the three endpoints for the positive control, Sodium Hydroxyde, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
Irritation parameter:
corneal swelling 
Run / experiment:
Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180, and 240 minutes
(± 5 minutes) after the post-treatment rinse.
Value:
1
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
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.
Positive controls validity:
valid
Remarks:
The combination of the three endpoints for the positive control, Sodium Hydroxyde, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
Irritation parameter:
cornea opacity score
Run / experiment:
Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180, and 240 minutes
(± 5 minutes) after the post-treatment rinse.
Value:
0.5
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
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.
Positive controls validity:
valid
Remarks:
The combination of the three endpoints for the positive control, Sodium Hydroxyde, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.

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 enable to conclude that the test item TCB (1,3,5-trichlorobenzène) does not require
classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).
No signal word and hazard statement are required.
Executive summary:

The individual and average values for evaluation of corneal lesions are presented in Tables 7 to 9
hereafter.
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.5, corresponding to ICE class I;
- mean score of fluorescein retention: 1.0, corresponding to ICE class II;
- maximal mean corneal swelling: 1 %, corresponding to ICE class I.
The combination of the three endpoints for test item TCB (1,3,5-trichlorobenzène) was 2 x I, 1 x II.
The combination of the three endpoints for the positive control, Sodium Hydroxyde, 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.