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EC number: 276-339-5 | CAS number: 72102-40-0
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 31, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-rape-oil acyl derivs., Et sulfates
- EC Number:
- 305-488-1
- EC Name:
- 1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-rape-oil acyl derivs., Et sulfates
- Cas Number:
- 94552-41-7
- Molecular formula:
- Molecular formula of the major constituents: C31H64N2O5S1 (C22:1 carbon chain) C27H56N2O5S1 (C18:1 carbon chain)
- IUPAC Name:
- 1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-rape-oil acyl derivs., Et sulfates
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Source of Bovine Eyes
Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 32 ± 1 ºC for 120 minutes
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- ca. 29.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No prediction can be made
- Other effects / acceptance of results:
- The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7. The positive control acceptance criterion was therefore satisfied. The negative control gave opacity of ≤3.0 and permeability ≤0.077. The negative control acceptance criteria were therefore satisfied.
Any other information on results incl. tables
Results
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in below table:
Treatment |
Cornea number |
Opacity |
Permeability (Optical density) |
In Vitro Irritancy Score |
|||||
Pre-treatment |
Post-treatment |
Post incubation |
Post-incubation - Pre‑treatment |
Corrected value |
|
Corrected value |
|||
Negative control# |
1 |
3 |
3 |
4 |
1 |
|
0.007 |
|
|
2 |
3 |
2 |
2 |
0 |
|
0.011 |
|
|
|
3 |
4 |
2 |
2 |
0 |
|
0.007 |
|
|
|
|
|
|
|
0.3* |
|
0.008¨ |
|
0.5 |
|
Positive control# |
4 |
6 |
40 |
37 |
31 |
30.7 |
0.794 |
0.786 |
|
5 |
3 |
31 |
33 |
30 |
29.7 |
1.960 |
1.952 |
|
|
6 |
2 |
24 |
26 |
24 |
23.7 |
1.885 |
1.877 |
|
|
|
|
|
|
|
28.0· |
|
1.538· |
51.1 |
|
Test substance |
13 |
1 |
6 |
21 |
20 |
19.7 |
0.747 |
0.739 |
|
14 |
3 |
6 |
22 |
19 |
18.7 |
0.824 |
0.816 |
|
|
15 |
1 |
6 |
21 |
20 |
19.7 |
0.539 |
0.531 |
|
|
|
|
|
|
|
19.3· |
|
0.695· |
29.8 |
* = Mean of the post-incubation-pre‑treatment values
# = Control data shared with Envigo - Shardlow study number PS75FR
Corneal Epithelium Condition
The condition of each cornea is given in below table:
Treatment |
Cornea Number |
Observation |
|
Post Treatment |
Post Incubation |
||
Negative Control# |
1 |
Clear |
Clear |
2 |
Clear |
Clear |
|
3 |
Clear |
Clear |
|
Positive Control# |
4 |
Cloudy |
Cloudy |
5 |
Cloudy |
Cloudy |
|
6 |
Cloudy |
Cloudy |
|
Test Substance |
13 |
Clear |
Cloudy |
14 |
Clear |
Cloudy |
|
15 |
Clear |
Cloudy |
# = Control data shared with Envigo - Shardlow study number PS75FR
The corneas treated with the test substance were clear post treatment and cloudy post incubation. The corneas treated with the negative control substance were clear post treatment and post incubation. The corneas treated with the positive control substance were cloudy post treatment and post incubation.
In Vitro Irritancy Score
The In Vitro irritancy scores are summarized as follows:
Treatment |
In Vitro Irritancy Score |
Test Substance |
29.8 |
Negative Control |
0.5 |
Positive Control |
51.1 |
Criteria for an Acceptable Test
The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7. The positive control acceptance criterion was therefore satisfied. The negative control gave opacity of ≤3.0 and permeability ≤0.077. The negative control acceptance criteria were therefore satisfied.
Conclusion
Based on the study results, the study author concluded that no prediction of eye irritation could be made.
Applicant's summary and conclusion
- Interpretation of results:
- other: No prediction can be made based on EU CLP criteria
- Conclusions:
- Under study conditions, no prediction could be made about eye irritation potential of the test substance.
- Executive summary:
An in vitro study was conducted to determine the eye irritation potential of the the test substance, 'C18-unsatd and C22-unsatd. AAP EDM-ES' (active: 104%), using Bovine Corneal Opacity and Permeability (BCOP) method, according to the OECD Guideline 437 and EU B.47 Method, in compliance with GLP. The undiluted test substance and reference substances were applied to the test system for 10 minutes followed by an incubation period of 120 minutes. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability), were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The IVIS of the test substance was determined to be 29.8 which is well below the corrosive limit of 55 and above the non-corrosive limit of 3; therefore no predictions could be made. Therefore based on EU CLP criteria, no prediction could be made about eye irrtation potential of the test substance. The IVIS of the positive control was within the range of 31.6 to 58.7, therefore acceptance criterion was satisfied. The negative control gave opacity of ≤3.0 and permeability ≤0.077, therefore the negative control acceptance criteria were satisfied. The quality criteria required for acceptance of results in the test were satisfied. Under the study conditions, no prediction could be made about eye irritation potential of the test substance (Envigo, 2017).
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.
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