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Eye irritation

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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:
2012
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

Constituent 1
Chemical structure
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 dihydrogen triphosphate
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

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.)