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EC number: 237-714-9 | CAS number: 13939-25-8
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Jul - 28 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Aluminium dihydrogen triphosphate
- EC Number:
- 237-714-9
- EC Name:
- Aluminium dihydrogen triphosphate
- Cas Number:
- 13939-25-8
- Molecular formula:
- AlH2O10P3
- IUPAC Name:
- aluminium(3+) bis(hydrogen phosphonatooxy)phosphinate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Aluminium dihydrogen triphosphate
- Physical state: off white powder
- Analytical purity: assay min. 95.0% (based on min. 16.5% Al2O3 and min. 72.5% P2O5)
- Purity test date: 15.06.2012
- Lot/batch No.: MV 500
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.26 or 2.86 kg
- Housing: The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet: 2930 Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK, ad libitum
- Water: mains drinking water, ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (approx. 98 mg) - Duration of treatment / exposure:
- single instillation without rinsing
- Observation period (in vivo):
- 14 days
Reading time points: 1, 24, 48 and 72 h and 7 and 14 days - Number of animals or in vitro replicates:
- 2 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean after 24-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean after 24-72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean after 24-72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean after 24-72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: small area of petechial haemorrhage on the nictitating membrane observed at 24 and 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean after 24-72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean after 24-72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean after 24-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Individua scores for ocular irritation are given in Table 1.
Scattered or diffuse corneal opacity was noted in one treated eye one hour after treatment, in both treated eyes at the 24 and 48 h observations and in one treated eye at the 72 h observation.
Iridial inflammation was noted in both treated eyes one hour after treatment and at the 24, 48 and 72 h observations and in one treated eye at the 7-Day observation.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24, 48 and 72 h observations with minimal conjunctival irritation noted at the 7-Day observation.
A small area of petechial haemorrhage on the nictitating membrane was noted in one treated eye at the 24 and 48 h observations.
Both treated eyes appeared normal at the 14-Day observation. - Other effects:
- Both animals showed expected gain in bodyweight during the study.
No further local or systemic effects were noted.
Any other information on results incl. tables
Table 1. Individual eye irritation scores
| Animal No. | Time point | Irritation parameter | |||
| Cornea score (opacity) | Iris score | Conjunctivae score (redness) | Chemosis score | ||
| 1 | 1 h | 1 | 1 | 2 | 2 |
| 24 h | 1 | 1 | 2 Pt | 2 | |
| 48 h | 1 | 1 | 2 Pt | 2 | |
| 72 h | 1 | 1 | 2 | 1 | |
| 7 days | 0 | 1 | 1 | 1 | |
| 14 days | 0 | 0 | 0 | 0 | |
| Mean after 24-72 h | 1 | 1 | 2 | 1.67 | |
| 2 | 1 h | 0 | 1 | 2 | 2 |
| 24 h | 1 | 1 | 2 | 2 | |
| 48 h | 1 | 1 | 2 | 2 | |
| 72 h | 0 | 1 | 2 | 2 | |
| 7 days | 0 | 0 | 2 | 1 | |
| 14 days | 0 | 0 | 0 | 0 | |
| Mean after 24-72 h | 0.67 | 1 | 2 | 2 | |
Pt = Small area of petechial haemorrhage on the nictitating membrane
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced individual scores of 1/0.67 for corneal opacity, 1/1 for iritis, 2/2 for conjunctival redness and 1.67/2 for chemosis, calculated as the mean scores following gradings at 24, 48 and 72 hour after instillation. Observed effects were fully reversible within the observation period.
Therefore, the test item meets the classification criteria for Eye Irritation Category 2 according to Regulation (EC) No 1272/2008 (CLP) and for Eye Irritation Category 2A accoridng to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
The test item is thus considered to be eye irritating.
CLP: Eye Irrit. 2 (H319: Causes serious eye irritation.)
GHS: Eye Irrit. 2A (H319: Causes serious eye irritation.)
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