Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 942-548-1 | CAS number: -
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-09-22 to 2021-11-18
- 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)
- Version / remarks:
- adopted 25 June 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Salt reaction of cobalt(2+) and C2/C8/C20 carboxylates
- EC Number:
- 942-548-1
- Molecular formula:
- (CnH2n-102/Cn’H2n’-1O2) Co with n, n’ = 2 or 8 or 20
- IUPAC Name:
- Salt reaction of cobalt(2+) and C2/C8/C20 carboxylates
- Test material form:
- solid: pellets
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 30 mg of the test item was applied, after being reduced to fine powder, and under fume hood, for 10 seconds to the cornea such that the entire surface of the cornea was evently covered with the test item. Then the eyes were rinsed twice wiith 10 mL of physiological saline at ambient temperature.
Concurrent negative control (physiological saline - Dutscher batch n° C0543A01) and positive control (sodium hydroxide - Fisher Scientific - batch n° 00000) were included in this experiment. One eye was treated with 30 µL of negative control and three eyes were treated with 30 mg of positive control. Then, the controls underwent the entire testing procedure. - Duration of post- treatment incubation (in vitro):
- All observations of the cornea and measurement of corneal thickness were performed using a Haag-Streit BP900 slit-lamp microscope with depth-measuring device n° I. For the measurement of corneal thickness, the slit-width was set at 9½ equalling 0.095 mm.
Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse. - Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 45 min pre-treatment
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 75 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 120 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 180 min
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 240 min
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 45 min pre-treatment
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Value:
- 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 11
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 30 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 11
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 75 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 120 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 180 min
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Value:
- 13
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: time = 240 min
- Other effects / acceptance of results:
- The ocular reactiond 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: 2.0, corresponding to ICE class III;
- maximal mean corneal swelling: 13%, corresponding to ICE class II.
The combination of the three endpoints for the test item was 1 x I, 1 x III, 1 x II.
Any other information on results incl. tables
The combination of the 3 endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.
The combination of the 3 endpoints for the negative control, physiological saline, was 3 x I. Therefore the negative control is classified as 'No category' as expected.
Applicant's summary and conclusion
- Interpretation of results:
- other: No prediction can be made.
- Conclusions:
- In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions lead to the category 'No prediction can be made' as defined by the O.E.C.D. test guideline n° 438. Therefore, the test item is not predicted as causing sever eye damage (Caetegory) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing is required to establish a definitive classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
