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EC number: 231-967-9 | CAS number: 7782-87-8
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Endpoint summary
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
There were no data for irritation/corrosion with Potassium phosphinate however studies to test the irritant potential of Sodium hypophosphite were available as follows:
- an in vivo dermal irritation test in rabbits (performed according to 49 CFR Part 173.240 method from the US Hazardous Materials Regulations. This method was comparable to the OECD 404 guideline issued in 1981. The study predates GLP requirements).
- an in vivo eye irritation test in rabbits (method comparable to EPA 870.2400 and OECD 405 guidelines, GLP compliance not stated in the study report).
Based on these studies, Sodium hypophosphite is considered to be non-irritant for skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no precise data, 72 hours minimum
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study with acceptable restrictions performed using a method equivalent to the OECD guideline 404. No data on the purity of the tested substance, no observation period for the reversibility and no scoring at 60 minutes after patch removal.
- Qualifier:
- according to guideline
- Guideline:
- other: DOT, Hazardous Materials Regulations, 49 CFR Part 173.240
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- . Reliability scoring based on 1981 OECD guideline for test n° 404.
- Deviations:
- yes
- Remarks:
- : no observation period for reversibility, no scoring at 60 minutes after patch removal.
- GLP compliance:
- no
- Remarks:
- study predates GLP requirements.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2530 - 3167 grams
No more data available - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 milligrams by rabbit on shaved backs (intact or abraded sites) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive
- Testing area: intact (shaved) and abraded skins
REMOVAL OF TEST SUBSTANCE
- Washing: tepid tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- <= 0.6
- Irritation parameter:
- erythema score
- Remarks:
- Test item applied onto intact skin
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Remarks:
- Test item apllied onto the intact skin
- Basis:
- animal #2
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Remarks:
- Test item applied onto the intact skin
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Remarks:
- Test item applied onto the intact skin
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- test item applied onto the intact skin
- Basis:
- animal #2
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Test item applied onto the intact skin
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- For raw data see tables in the "remarks on results" freetext.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC)
- Conclusions:
- Under the experimental conditions of this study and according to the criterai laid down in CLP (Reg 1272/2008/EC), the test item Sodium hypophosphite is considered as non-irritant to the skin.
- Executive summary:
The potential of sodium hypophosphite to induce skin irritation or corrosion was assessed in adult New Zealand white rabbits (3 males and 3 females) using the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations. This method was comparable to the OECD 404 guideline issued in 1981. The study predates GLP requirements.
The rabbits were dermally exposed to 500 mg of sodium hypophosphite for 4 hours on prepared shaved backs. 3 animals received the test item onto an intact skin while the remaining received the test item onto an abraded area.The test substance was held in contact with the skin by means of an occlusive dressing. Cutaneous reactions were observed 24, 48 and 72 hours after removal of the dressing.
A slight erythema (scoring value 1) was observed in all animals at the 24 -hour reading and was still persistent in 1out 3 animals treated onto an intact skin and 2 out 3 animals treated on an abraded area at the 72 -hour reading. Only one animal with intact skin showed a slight oedema (soring value 1) at the 72 -hour reading.
According to the criteria laid down in EC regulation 1272/2008/EC, Sodium hypophosphite is considered as non-irritant to the skin and is not classified.
Reference
Raw data for irritant/corrosive response:
Each animal was evaluated according to the grading scale of theOECD 404 guideline.
Table 1: Primary skin irritation scoring values
Intact skin |
Abraded skin |
||||||||
Hours |
Hours |
||||||||
Observations | Grade | 4 | 24 | 48 | 72 | 4 | 24 | 48 | 72 |
Erythema, Eschar formation |
0 |
2/3 |
2/3 |
1/3 |
|||||
1 |
3/3 | 3/3 | 3/3 | 1/3 | 1/3 |
3/3 | 3/3 | 2/3 | |
2 |
|||||||||
3 |
|||||||||
4 |
|||||||||
Edema Formation |
0 |
3/3 | 3/3 | 3/3 | 2/3 | 3/3 | 3/3 | 3/3 | 3/3 |
1 |
1/3 |
||||||||
2 |
|||||||||
3 |
|||||||||
4 |
Table 2: Corrosion results
Intact skin | Abraded skin | |||||||
Hours |
Hours |
|||||||
Observations | 4 | 24 | 48 | 72 | 4 |
24 |
48 |
72 |
Necrosis (corrosion) |
0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1982-03-09 to 1982-03-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Methodology used is similar to OECD 405 and OPPTS 870.2400 guidelines. No details on experimental conditions. Only raw data reported.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- . Reliability scoring based on 1981 OECD guideline for test n°405
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- IN-LIFE DATES: From: 1982-03-09 To: 1982-03-16 (or 1982-03-19 for one animal)
No more data available - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- Ten days which was the duration needed to clear all ocular effects.
- Number of animals or in vitro replicates:
- 9 rabbits ( 6 animals with eyes not washed after instillation of the test item and 3 animals with eyes washed after instillation of the test item).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, for 3 animals
- Time after start of exposure: unknown
SCORING SYSTEM: cf free text of materials and methods. Grading scale used is equivalent to the one used in OECD 405.
No more data available - Irritation parameter:
- cornea opacity score
- Remarks:
- : Eyes not rinsed
- Basis:
- mean
- Remarks:
- : 6 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Remarks:
- : Eyes not rinsed
- Basis:
- mean
- Remarks:
- : 6 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- : (Redness) Eyes not rinsed
- Basis:
- mean
- Remarks:
- : 6 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Remarks:
- : Eyes not rinsed
- Basis:
- mean
- Remarks:
- : 6 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- : Eyes rinsed
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Remarks:
- : Eyes rinsed
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- : (redness) Eyes rinsed
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- : Eyes rinsed
- Basis:
- mean
- Remarks:
- : 3 animals
- Time point:
- other: mean of the 24, 48 and 72 hours readings
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- Without rinsing, a slight (grade1) and fully reversible (within 10 days) redness of the conjunctivae was observed in all rabbits. A slight chemosis
(grade 1) was present in 4 out of 6 rabbits but the reaction cleared within 3 days.
The washing procedure did not modify the ocular reactions. All animals showed a slight (grade 1) and transient redness of the conjunctivae. Chemosis was observed in 1 out 3 animals but the reaction cleared within 4 days.
No lesions of cornea or iris were reported whatever the procedure od treatment. (See Table 1 for complete raw data) - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC)
- Conclusions:
- Under the experimental conditions of this study and according to the criterai laid down in CLP (Reg 1272/2008/EC), the test item Sodium
hypophosphite is considered as non-irritant to the eyes. - Executive summary:
The potential of Sodium hypophosphite to induce eye irritation was assessed in 9 rabbits according to methods similar to OPPTS 870.2400 and OECD 405 guidelines. There were no information in the report about GLP compliance.
A single dose of 100 mg of the test item was instilled into one eye, the other eye was not treated and served as control. For 6 rabbits, the eyes were not rinsed after administration of the test item while a washing procedure was applied for 3 other animals .Ocular reactions were observed 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal.
Mean scores calculated over 24, 48 and 72 hours for the 6 animals without rinsing were 0.33 for chemosis, 0.89 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 10 and 3 days respectively.
Washing procedure did not change the ocular reactions.
Under these experimental conditions,Sodium hypophosphite was considered non- irritant when administered by ocular route to rabbits.
Reference
Table 1: Synthesis of the raw results
Scores per animal |
Observation |
Pre-dose |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 7 |
Day 10 |
Eyes not rinsed (6 animals) |
Cornea opacity (0-4) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
nd/0 |
Cornea area (0-4) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
nd/0 |
|
Iris (0-2) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
nd/0 |
|
Conjonctivae redness (0-3) |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
1/1/1/1/1/1 |
1/0/1/1/1/0 |
1/0/0/1/1/1 |
0/0/0/0/0/1 |
nd/0 |
|
Conjonctivae chemosis (0-4) |
0/0/0/0/0/0 |
0/0/1/1/1/0 |
0/0/1/1/0/1 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
nd/0 |
|
Conjonctivae discharge (0-3) |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
1/1/1/1/0/0 |
0/1/1/1/0/0 |
0/1/1/1/1/0 |
0/0/0/0/0/0 |
nd/0 |
|
Total |
|
0/0/0/0/0/0 |
4/4/6/6/6/4 |
4/4/6/6/2/4 |
2/2/4/4/2/0 |
2/2/2/4/2 |
0/0/0/0/0/2 |
|
Eyes rinsed |
Cornea opacity (0-4) |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
nd |
Cornea area (0-4) |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
nd |
|
Iris (0-2) |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
nd |
|
Conjonctivae redness (0-3) |
0/0/0 |
1/1/1 |
0/1/1 |
0/1/0 |
0/1/0 |
0/0/0 |
nd |
|
Conjonctivae chemosis (0-4) |
0/0/0 |
0/0/1 |
0/0/1 |
0/0/1 |
0/0/0 |
0/0/0 |
nd |
|
Conjonctivae discharge (0-3) |
0/0/0 |
2/1/1 |
0/0/1 |
0/0/1 |
0/0/1 |
0/0/0 |
nd |
|
Total |
|
0/0/0 |
6/4/6 |
0/2/6 |
0/2/4 |
0/2/2 |
0/0/0 |
|
To obtain subtotal for the cornea multiply the product of the opacity and area scores by 5. For the iris subtotal multiply the score by 5 and for conjunctivae multiply the sum of the scores (redness, chemosis and discharge) by 2.
Total: sum of all subtotals per animal
Table 2: Irritant/corrosive response data of each animal except washed animals according to OPPTS and OECD guidelines scoring system
Score at time point/ Reversibility |
Cornea |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
0/0/1/1/1/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
0/0/1/1/0/1 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/0/1/1/1/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.89 |
0.33 |
Reversibility* |
- |
- |
c.(10 days) |
c. |
* c.=completely reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data for Sodium hypophosphite:
Skin irritation/corrosion:
One valid study is recorded for this endpoint and was chosen as key study (Wilson, 1977).
The potential of sodium hypophosphite to induce skin irritation or corrosion was assessed in rabbits using the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations. This method was comparable to the OECD 404 guideline issued in 1981. The study was performed before the implementation of GLP.
Six rabbits were dermally exposed to 500 mg of sodium hypophosphite for 4 hours. 3 received the test item onto an intact skin while the remaining received the test item onto an abraded area. The test substance was held in contact with the skin by means of an occlusive dressing. Cutaneous reactions were observed 24, 48 and 72 hours after removal of the dressing. No observation and no scoring were performed after 72 hours.
A slight erythema (scoring value 1) was observed in all animals at the 24 -hour reading and was still persistent in 1out 3 animals treated onto an intact skin and 2 out 3 animals treated on an abraded area at the 72 -hour reading. Only one animal with intact skin showed a slight oedema (scoring value 1) at the 72 -hour reading.
Based on these results and according to the criteria laid down in EC regulation 1272/2008/EC and EU directive 67/548/EEC, Sodium hypophosphite is considered as non-irritant to the skin and is not classified.
Eye irritation:
One study is recorded for this endpoint and was chosen as a key study.
The potential of Sodium hypophosphite to induce eye irritation was assessed in 9 rabbits according to methods similar to OPPTS 870.2400 and OECD 405 guidelines. There were no information in the report about GLP compliance.
A single dose of 100 mg of the test item was instilled into one eye, the other eye was not treated and served as control. For 6 rabbits, the eyes were not rinsed after administration of the test item while a washing procedure was applied for 3 other animals .Ocular reactions were observed 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were noted for each animal.
Mean scores calculated over 24, 48 and 72 hours for the 6 animals without rinsing were 0.33 for chemosis, 0.89 for redness of the conjunctiva, 0 for iris lesions and 0 for corneal opacity. Redness and chemosis were fully reversible within 10 and 3 days respectively.
Washing procedure did not change the ocular reactions.
Based on these results and according to the criteria laid down in EC regulation 1272/2008/EC and EU directive 67/548/EEC, Sodium hypophosphite is considered as non-irritant when administered by ocular route and is not classified.
Justification for classification or non-classification
According to the criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC, Potassium phosphinate has not to be classified for skin irritation/corrosion nor eye irritation.
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