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Registration Dossier
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EC number: 410-800-5 | CAS number: 143239-08-1 ITC 288/S
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 12 October 1992 To 16 October 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Draize test.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
- EC Number:
- 410-800-5
- EC Name:
- A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
- Cas Number:
- 143239-08-1
- Molecular formula:
- There is no molecular formula available, as the reference substance is a multi- constituent reaction mass. The molecular formulae of the constituents are documented in section 1.2.
- IUPAC Name:
- dotriacontasodium (1R,2S,3R)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (1R,2S,3S)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (1S,2R,3S)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (1S,2S,3S)-1-phosphonatobutane-1,2,3,4-tetracarboxylate (2R)-2-phosphonatobutanedioate (2S)-2-phosphonatobutanedioate
- Details on test material:
- - Physical state: white powder
- Storage condition of test material: room temperature under silica gel
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheschire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.61-3.18 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 53-55
- Air changes (per hr): 15
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 12 October 1992 To: 16 October 1992
Test system
- Vehicle:
- not specified
- Controls:
- other: left eye was used for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.1 ml of the test material, which was found to weight approximately 93 mg was placed into the conjunctival sac of the right eye - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 (4 males and 2 females)
- Details on study design:
-
SCORING SYSTEM: Draize scale for scoring ocular irritation
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by use of the light source from a standard ophtalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hr
- Score:
- 0.17
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hr
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 hr
- Score:
- 0.55
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Irritant / corrosive response data:
- A single application of the test material to a right eye of six rabbits produced diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Dulling of the normal lustre of the corneal surface was confined to one treated eye one hour after treatment. All treated eyes appeared normal 72 hours after treatment.
- Other effects:
- None
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
| score at time point/ Reversibility | Cornea Max. score:4 |
Iris Max. score:2 |
Conjunctivae Max. score:3 |
Chemosis Max. score:4 |
| 1h | 0/0/0/d/0/0 | 1/1/1/1/1/1 | 2/2/2/2/2/2 | 2/2/2/2/2/2 |
| 24h | 0/0/1/1/1/0 | 0/0/1/1/1/0 | 2/1/2/1/2/1 | 1/1/2/1/1/1 |
| 48h | 0/0/1/1/0/0 | 0/0/0/0/0/0 | 1/1/1/1/1/1 | 1/0/1/0/1/0 |
| 72h | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
| Average 24h, 48h, 72h | 0.28 | 0.17 | 0.83 | 0.55 |
| Reversibility *) | c. | c. | c. | c. |
d = dulling of the normal lustre of the corneal surface
c. = completely reversible
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, ITC 288 is slightly irritating to eyes. However, no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
- Executive summary:
In a primary eye irritation study (Tuffnell, 1992), six New Zealand rabbits were exposed to ITC 288. Animals were observed for 3 days. Irritation was scored by the draize scale. Dulling of the normal lustre of the cornea surface was noted in one treated eye one hour after treatment. Diffuse corneal opacity was noted in three treated eyes at the 24 -hour observation and in two treated eyes at the 48 -hour observation. No other adverse corneal effects were noted. Iridial inflammation was noted in all treated eyes one hour after treatment and in three treated eyes at the 24 -hour observation. No other adverse iridial effects were noted. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal to moderate conjunctival irritation at the 24 -hour observation and minimal conjunctival irritation at the 48 -hour observation. All treated eyes appeared normal 72 -hours after treatment. A single application of ITC 288 to the intact eye of six rabbits produced mild irritation which desappeared. Under the test conditions of this study, ITC 288 is slightly irritating to eyes but no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
This eye irritation study is classified as acceptable. It satifies the guideline requirement for an eye irritation study in the rats.
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