1,3,5-trichlorobenzene

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

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.

Results 2

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.

Results 3

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.