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EC number: 235-979-5 | CAS number: 13078-36-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well-documented publication which meets basic scientific principles
- Justification for type of information:
- The source substance (DTPA 5Na) and the target substance (DTPA 3Na) are the pentasodium and trisodium salts of the same organic acid and are therefore structurally very similar. The purity/impurity profile for the source material is not characterised (40% solution as supplied) in the acute eye irritancy robust study summary, but since the target material is > 99.9% pure and contains no detectable impurities, the extrapolation of acute irritant properties from the source material to the target material is considered valid, particularly in view of the very conservative extrapolation resulting from the significant difference in pH between the two substances (12.52 for DTPA 5Na and 7.5 for DTPA 3Na). The source material eye irritation study was conducted according to OECD test guideline 405 and is considered reliable with restrictions (Category 2).
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The source substance (DTPA 5Na) and the target substance (DTPA 3Na) are the penta-sodium and tri-sodium salts of the same organic acid and are therefore structurally very similar. They are of comparable high water solubility and DTPA trisodium salt is neutral and DTPA pentasodium salt alkaline in aqueous solution (7.5 for DTPA 3Na and 12.52 for DTPA 5Na). Extrapolation of irritancy potential from the source material to the target substance is therefore considered valid as a 'worst case' scenario,
- Reason / purpose for cross-reference:
- read-across: supporting information
- Specific details on test material used for the study:
- > 99% purity
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Conclusions:
- DTPA trisodium salt is predicted to be slightly irritant to eyes. .
- Executive summary:
Using a read-across extrapolation approach from an OECD 405 guideline study on the structural analogue DTPA pentasodium salt, DTPA trisodium salt is predicted to be slightly irritant to eyes. The read-across is supported by the close structural similarity of the two substances and the neutral, as opposed to alkaline, pH of DTPA trisodium salt.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
- EC Number:
- 205-391-3
- EC Name:
- Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
- Cas Number:
- 140-01-2
- Molecular formula:
- C14H23N3O10.5Na
- IUPAC Name:
- pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
- Test material form:
- liquid
- Details on test material:
- Trilon C Flussig
approx 40% pentasodium DTPA
Approx 60% water
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Housing: single housing per stainless steel cage (area about 40 x 51 cm)
- Diet (e.g. ad libitum): Ovator Solikanin, Duesseldorf, Germany
- Water (e.g. ad libitum): tap wter (about 250 ml per animal)
- Acclimation period: 8 days before starting the experiment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The acclimatization period was 8 days before starting the study; same housing conditions as during the testing period. Application site: conjunctival sac of the right eye. Observations were made 1 h, 24 h, 48 h, 72 h and 8 days after application. The test substance was not rinsed out.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 6
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 4
- Max. score:
- 6
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3
- Max. score:
- 5
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
| Observations after | Animal No. | Cornea | Iris | Conjunctiva | Single irritation score | ||||
| Cloudiness | Area | Reddening | Swelling | Secretion | |||||
| 24 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
| 2 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | ||
| 3 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | ||
| Mean | 6 | ||||||||
| 48 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
| 2 | 0 | 0 | 0 | 2 | 0 | 1 | 6 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | ||
| Mean | 4 | ||||||||
| 72 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | |
| 2 | 0 | 0 | 0 | 2 | 0 | 1 | 6 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | ||
| Mean | 3 | ||||||||
| 8 days | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Mean | 0 | ||||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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