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EC number: 231-449-2 | CAS number: 7558-80-7
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo. Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-07-15 to 1986-07-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No guideline followed
- Principles of method if other than guideline:
- Monosodium Phosphate (MSP) Technical was instilled into the test eyes of four New Zealand White rabbits at a dose of 0.1 g. The eyes of two rabbits remained unwashed while the eyes of the remaining two rabbits were gently washed with 100 mL of tap water approximately 20 - 30 seconds after treatment. Eyes were assessed for irritation using the method of Draize at 1, 24, 48 and 72 h after instillation.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium dihydrogenorthophosphate
- EC Number:
- 231-449-2
- EC Name:
- Sodium dihydrogenorthophosphate
- Cas Number:
- 7558-80-7
- Molecular formula:
- H3O4P.Na
- IUPAC Name:
- sodium dihydrogen phosphate
- Details on test material:
- Identity: Monosodium phosphate (MSP)
Formulation: Technical
Reference number: 485B2097U
Storage: room temperature
Purity: > 99 % based on water content
Stability: stable indefinitely
Chemical composition: NaH2PO4
FMC-T#: 429
Physical description: white granules
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania, USA.
- Age at study initiation: Young adult
- Weight at study initiation: 2.63 to 2.97 kg
- Housing: Individual housing in stainless steel rabbit cages. DACB cageboard bedding was used in the litter pans.
- Diet: Ad libitum
- Water: Ad libitum
- Sex of animals: Male
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69 - 74ºF
- Humidity (%): 52 - 58 %
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 15-07-1986 To: 19-7-1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each rabbit was treated; and the remaining left eye was used as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 2 rabbits were exposed for approximately 30 seconds after treatment.
2 rabbits remined unwashed and therefore exposed for 72 h. - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 4 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of two rabbits remained unwashed. The remaining two rabbits were gently washed with 100 mL of tap water at a rate of 100 mL per minute.
- Time after start of exposure: approximately 20 - 30 seconds after treatment.
SCORING SYSTEM: Draize. The primary irritation index was calculated separately for both washed and unwashed eyes for each scoring interval. Additional assessment of irritation provided by FMC Internal guidelines.
TOOL USED TO ASSESS SCORE: 2 % sodium fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One-hour after instillation, all eyes exhibited mild conjunctivitis. At the 24-h scoring, one of the washed had slight conjunctival redness; both unwashed eyes had slight conjuncitvitis. Washed eyes recovered within 48 h and unwashed eyes recovered within 72 h of dosing. Washing the eyes with tap water shortly after exposure slightly decreased both the severity and the duration of the irritation observed.
- Other effects:
- None reported
Any other information on results incl. tables
Table 1. Pretest eye examination:
Animal No. |
Exam method |
Right eye |
Left eye |
Body weight |
B5431M |
Penlight |
N |
N |
2.63 |
Fluorescein |
N |
N |
|
|
B5436M |
Penlight |
N |
N |
2.97 |
Fluorescein |
N |
N |
|
|
B5430M |
Penlight |
N |
N |
2.97 |
Fluorescein |
N |
N |
|
|
B5432M |
Penlight |
N |
N |
2.70 |
Fluorescein |
N |
N |
|
|
Mean |
2.82 |
|||
± S.D. |
± 0.178 |
Table 2. Individual eye scores: 1 hour
Animal Number |
Cornea |
Iris |
Conjunctivae |
Other comments |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
||
B5431M |
0 / 0 |
0 |
1 |
1 |
3 |
0 |
B5436M |
0 / 0 |
0 |
1 |
1 |
3 |
0 |
B5430M (w) |
0 / 0 |
0 |
0 |
1 |
3 |
0 |
B5432M (w) |
0 / 0 |
0 |
1 |
0 |
3 |
0 |
Primary Eye Irritation Index = Unwashed 10.0/110, washed 8.0/110
(w) = washed
Table 3. Individual eye scores: 24 hour
Animal Number |
Cornea |
Iris |
Conjunctivae |
Cornea |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
Stain / Area |
|
B5431M |
0 / 0 |
0 |
1 |
0 |
1 |
0 / 0 |
B5436M |
0 / 0 |
0 |
1 |
0 |
2 |
0 / 0 |
B5430M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
0 / 0 |
B5432M (w) |
0 / 0 |
0 |
1 |
0 |
0 |
0 / 0 |
Primary Eye Irritation Index = Unwashed 5.0/110, washed 1.0/110
(w) = washed
Individual eye scores: 48 hour
Animal Number |
Cornea |
Iris |
Conjunctivae |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
|
B5431M |
0 / 0 |
0 |
1 |
0 |
0 |
B5436M |
0 / 0 |
0 |
1 |
0 |
2 |
B5430M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
B5432M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
Primary Eye Irritation Index = Unwashed 4.0/110, washed 0/110
(w) = washed
Table 4. Individual eye scores: 72 hour
Animal Number |
Cornea |
Iris |
Conjunctivae |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
|
B5431M |
0 / 0 |
0 |
0 |
0 |
0 |
B5436M |
0 / 0 |
0 |
0 |
0 |
0 |
B5430M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
B5432M (w) |
0 / 0 |
0 |
0 |
0 |
0 |
Primary Eye Irritation Index = Unwashed 0/110, washed 0/110
(w) = washed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the author concludes that the test material is temporarily approximated to be minimally irritating to unwashed eyes and practically non-irritating to washed eyes.
Although the study has only been conducted on two animals (unwashed eyes) it is considered to be sufficient for classification and labelling due to the minimal effects noted and is therefore submitted as a key study with supporting data also provided to support the conclusions on classification and labelling.
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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