Registration Dossier
Registration Dossier
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EC number: 228-510-0 | CAS number: 6284-83-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- DNTCB (1,3,5-trichloro-2,6-dinitrobenzene) 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- 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:
- yes
- Remarks:
- this deviation is considered as without impact on the results of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,5-trichloro-2,6-dinitrobenzene
- Cas Number:
- 6284-83-9
- IUPAC Name:
- 1,3,5-trichloro-2,6-dinitrobenzene
- Reference substance name:
- 1,3,5-trichloro-2,4-dinitrobenzene
- EC Number:
- 228-510-0
- EC Name:
- 1,3,5-trichloro-2,4-dinitrobenzene
- Cas Number:
- 6284-83-9
- Molecular formula:
- C6HCl3N2O4
- IUPAC Name:
- 1,3,5-trichloro-2,4-dinitrobenzene
- Test material form:
- solid: particulate/powder
- Details on test material:
- • Date received: 17 September 2021
• CAS No.: 6284-83-9
• EINECS No.: 228-510-0
• Container: plastic flask (n=1)
• Category: Chemical Substance
• Quantity: 111.70 g (container + content + label)
• Storage: room temperature
• Homogeneity: yes
• Form: solid (powder)
• Stability: not specified
• Colour: yellowish
• Production date: not specified
• Expiry date: February 2024
• Composition: 1,3,5-trichloro-2,6-dinitrobenzene • Purity: 99.24%
It was identified under the code number: PH-21/0912.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: Isolated Chicken Eye
Test system
- Vehicle:
- not specified
- Controls:
- other:
- Duration of treatment / exposure:
- Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180, and 240 minutes
(± 5 minutes) after the post-treatment rinse.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- fluorescein retention score
- Value:
- 3
- 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.
- Remarks on result:
- other: corresponding to ICE class I
- Irritation parameter:
- corneal swelling
- 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.
- Remarks on result:
- other: corresponding to ICE class II
- Irritation parameter:
- cornea opacity score
- Value:
- 0.7
- 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.
- Remarks on result:
- other: corresponding to ICE class II;
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 DNTCB (1,3,5-trichloro-2,6-dinitrobenzene) 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.
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