Registration Dossier
Registration Dossier
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EC number: 232-221-5 | CAS number: 7790-76-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 - 10 Jan 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dicalcium pyrophosphate
- EC Number:
- 232-221-5
- EC Name:
- Dicalcium pyrophosphate
- Cas Number:
- 7790-76-3
- Molecular formula:
- Ca2O7P2
- IUPAC Name:
- dicalcium pyrophosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White (Hsdlf:NZW)
- 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: 2.61-2.93 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: 2930C Teklad Global Rabbit diet (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:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- single instillation without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Individual scores for ocular irritation are given in Table 1. The individual and mean scores as required for EU and GHS classification and labelling are presented in Table 2.
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes one hour after treatment.
Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one hour after treatment. Minimal conjunctival irritation noted in both treated eyes at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation. - Other effects:
- Individual bodyweights and bodyweight changes are given in Table 3.
Both animals showed expected gain in bodyweight during the study.
No further local or systemic effects were observed during the study period.
Any other information on results incl. tables
Table 1. Individual Scores for Ocular Irritation
Rabbit Number and Sex |
72824 Male |
72839 Male |
||||||
IPR = 1 |
IPR =2 |
|||||||
Time After Treatment [h] |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA Degree of opacity Area of cornea involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
IRIS |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
CONJUNCTIVAE Redness Chemosis Discharge |
1 1 1 |
1 1 0 |
0 0 0 |
0 0 0 |
1 2 2 |
1 1 1 |
0 0 0 |
0 0 0 |
IPR = Initial Pain Reaction
Table 2. Individual and Mean Scores for Cornea, Iris and Conjunctivae
Rabbit Number and Sex |
Time After Treatment [h] |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
72824 Male |
24 48 72 |
0 0 0 |
0 0 0 |
1 0 0 |
1 0 0 |
Mean |
0.0 |
0.0 |
0.3 |
0.3 |
|
72839 Male |
24 48 72 |
0 0 0 |
0 0 0 |
1 0 0 |
1 0 0 |
Mean |
0.0 |
0.0 |
0.3 |
0.3 |
|
Table 3. Individual Body Weights and Body Weight Changes
Rabbit Number and Sex |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 3 |
||
72824 Male |
2.93 |
3.00 |
0.07 |
72839 Male |
2.61 |
2.68 |
0.07 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced individual scores of 0/0 for corneal opacity, 0/0 for iritis, 0.3/0.3 for conjunctival redness and 0.3/0.3 for chemosis, calculated as the mean scores following grading at 24, 48 and 72 hour after instillation. Observed effects were fully reversible within the observation period.
Therefore, the test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the Globally Harmonised System of Classification and Labelling of Chemicals.
The test item is thus considered to be not irritating to rabbit eyes.
CLP: not classified
GHS: not classified
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