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EC number: 238-687-6 | CAS number: 14639-97-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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- Carcinogenicity
- Toxicity to reproduction
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- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- version 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diammonium tetrachlorozincate(2-)
- EC Number:
- 238-687-6
- EC Name:
- Diammonium tetrachlorozincate(2-)
- Cas Number:
- 14639-97-5
- Molecular formula:
- Cl4Zn.2H4N
- IUPAC Name:
- diammonium tetrachlorozincdiuide
- Details on test material:
- The substance was tested as powder.
Constituent 1
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30mg - Duration of treatment / exposure:
- 10 seconds
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- treatments:
-test substance treated chicken eye: treated with 30 mg diammonium tetrachlorozincate
-positive control chicken eye: treated with 30 mg imidazole
-negative control eye: treated with 30µL physiological saline (0.9% (w/v) NaCl solution
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cornea surface was rinsed thoroughly with 20ml physiological saline
- Time after start of exposure: after 10'' of exposure
SCORING SYSTEM:
The control eye and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Minor variations within ±5 minutes were considered acceptable.
The cornea thickness and cornea opacity were measured at all time points.
Fluorescein retention was measured on two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope/fluorescein
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- up to 75 minutes
- Value:
- 4.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- up to 240 minutes
- Value:
- 11.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: slight indication of irritation
- Irritation parameter:
- cornea opacity score
- Value:
- 3.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Value:
- 3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
The mean values of the treated eyes for maximum corneal thickness change, corneal opacity and fluorescein retention are given below. The conclusion on eye irritancy was based on the OECD guideline quantitative assessments.
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
4.3 % |
I |
Mean maximum corneal swelling at up to 240 min |
11.2 % |
II |
Mean maximum corneal opacity |
3.33 |
IV |
Mean fluorescein retention |
3.00 |
IV |
Other Observations |
Test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were cleared at 30 minutes after the post-treatment rinse. |
|
Overall ICE Class |
1xII 2xIV |
Based on this in vitro eye irritation in the isolated chicken eyes test with diammonium tetrachlorozincate(2-),the test item is irritant,UN GHS Classification: Category 1.
Positive Control
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
9.6 % |
II |
Mean maximum corneal swelling at up to 240 min |
24.1 % |
II |
Mean maximum corneal opacity |
4.00 |
IV |
Mean fluorescein retention |
3.00 |
IV |
Other Observations |
Imidazole was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces (3/3) were not cleared at 240 minutes after the |
|
Overall ICE Class |
1xIII 2xIV |
The positive controlImidazole was classified as severely irritating, UN GHS Classification: Category 1.
NEGATIVE Control
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
0.0 % |
I |
Mean maximum corneal swelling at up to 240 min |
0.0 % |
I |
Mean maximum corneal opacity |
0.00 |
I |
Mean fluorescein retention |
0.00 |
I |
Other Observations |
None |
|
Overall ICE Class |
3xI |
The negative control Physiological saline was classified as non-irritating, UN GHS Classification: No Category.
Table:Assessment of the general IN VITRO eye irritancy and regulatory GHS classification.
UN GHS Classification |
Combinations of the three ICE Classes |
No Category |
3×I 2×I, 1×II |
No prediction can be made |
Other combinations |
Category 1
|
3×IV 2×IV, 1×III 2×IV, 1×II* 2×IV, 1×I* Corneal opacity ≥ 3 at 30 min (in at least 2 eyes) Corneal opacity = 4 at any time point (in at least 2 eyes) Severe loosening of epithelium (in at least 1 eye) |
Remark:*:combinations of categories less likely to occur
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on this in vitro eye irritation assay in isolated chicken eyes with diammonium tetrachlorozincate(2-), the test item is irritant, UN GHS Classification: Category 1.
- Executive summary:
An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline (09 October 2017).
After the zero reference measurements, the eye was held in horizontal position and 30 mg powdered test itemwas applied onto the centre of the cornea in such a way that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with physiological saline. Positive control eyes were treated with 30 mg powdered Imidazole. The negative control eye was treated with 30 µL ofphysiological saline(0.9% (w/v) NaCl solution). In the study, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined.
The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in the experiment. Thus, the experiment was considered to be valid.
Slight corneal swelling was observed during the four-hour observation period on test item treated eyes. Severe cornea opacity change (severity 2 on one eye and severity 4 on two eyes) was observed on three eyes. Severe fluorescein retention change (severity 3) was noted on all three eyes.Test item was stuck on all cornea surfaces after the post-treatment rinse. The cornea surfaces were cleared at 30 minutes after the post-treatment rinse.
Based on this in vitro eye irritation assay in isolated chicken eyes with diammonium tetrachlorozincate(2-),the test item is irritant,UN GHS Classification: Category 1.
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