Registration Dossier
Registration Dossier
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EC number: 237-249-1 | CAS number: 13708-85-5
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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium phosphonate
- EC Number:
- 237-249-1
- EC Name:
- Disodium phosphonate
- Cas Number:
- 13708-85-5
- Molecular formula:
- Na2HPO3
- IUPAC Name:
- disodium phosphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): BRÜGGOLEN H-10 (STabilisator P)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0 to 3.2 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
0 - 10: non irritant
11 - 25: slightly irritant
26 - 56: moderately irritant
57 - 110: severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 7 d
- Score:
- 0
- Irritant / corrosive response data:
- The animals showed deviations from normal findings over a period of 2 days. Within this period, redness was observed. Within the 24 hours after the application, increased secretion were observed. No findings at cornea and iris were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test results, there is no need for classification according to (EU) No. 1272/2008.
- Executive summary:
Slight symptoms of irriation (redness, secretion) were observed within a period of 2 days after the application of the substance. All symptoms were fully reversible within 7 days
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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