Registration Dossier
Registration Dossier
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EC number: 231-837-1 | CAS number: 7758-23-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20/8/1984 to 7/11/1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Reactions at abraded skin sites were also observed, observations were not recorded at 48 hr
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing, also abraded skin tested, 48 hour reading is mising
- Principles of method if other than guideline:
- Study states protocols were consitent with or exceeded the requirements of EPA and OECD guidelines at the time of the study.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium bis(dihydrogenorthophosphate)
- EC Number:
- 231-837-1
- EC Name:
- Calcium bis(dihydrogenorthophosphate)
- Cas Number:
- 7758-23-8
- Molecular formula:
- CaH4O8P2
- IUPAC Name:
- calcium dihydrogen phosphate
- Details on test material:
- - Name of test material (as cited in study report): monocalcium phosphate anhydrous
- Physical state: solid; white powder
- Analytical purity: no data
- Lot/batch No.: 525
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Stauffland albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California
- Weight at study initiation: 1.642 - 2.146 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and non-abraded (shaved) sites
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 hours, 24 hours and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch²
- % coverage: no data
- Type of wrap if used: rubber damming
SCORING SYSTEM: Draize, 1965
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed either in intact or abraded skin.
- Other effects:
- Not applicable
Any other information on results incl. tables
Table 1: Results of a primary skin irritation study
Rabbit No |
Skin |
Erythema-eschar observation |
Edema observation |
Sum total |
Score* |
||||
4 hr |
24 hr |
72 hr |
4 hr |
24 hr |
72 hr |
||||
84-M-1084
|
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1085 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1086 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1087 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1088 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1089 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
*score = sum of individual values for each rabbit divided by six
Primary Irritant Score = 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Monocalcium phosphate was considered to be non-irritating. Calcium bis(dihydrogenorthophosphate) is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).
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