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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Study on analogous substance submitted as supporting data only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
up-and-down procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium pentahydrogen bis(phosphate)
EC Number:
238-961-5
EC Name:
Potassium pentahydrogen bis(phosphate)
Cas Number:
14887-42-4
Molecular formula:
H5KO8P2
IUPAC Name:
potassium pentahydrogen bis(phosphate)
Details on test material:
- Name of test material: PeKacid
- Substance type: white crystalline powder
- PSL reference No.: 060214-3H
- Lot/batch No.: #0001
- Storage: room temperature
- pH: 1 % water 2.2
- solubility: fully soluble in water
- stability: test substance was expected to be stable for the duration of testing.
- Expiration date: 2007-12-31
- Composition: the product is an inorganic phosphate salt.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: young adults 9 - 10 weeks
- Weight at study initiation: 165 - 220 g
- Fasting period before study: overnight by removing the feed from their cages. Feed was replaced approximately 3 - 4 h after dosing.
- Housing: singly in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Water: ad libitum
- Acclimation period: 6 - 17 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 ºC
- Photoperiod: 12 h light/dark cycle.


IN-LIFE DATES: From: 2005-09-27 To:2006-05-24

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kg administered as a 50 % w/w mixture.

DOSAGE PREPARATION: a tissue homogeniser was used ot facilitate the preparation of a homogenous mixture. Preliminary solubility tests indicated that mixtures in excess of 50 % were too viscous to be administered properly.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females only
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights were recorded prior to test substance administration and again on Days 7 and 14 (termination) following dosing. Animals were observed for mortality, signs of gorss toxicity and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin an fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systmes, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea and coma.
- Necropsy of survivors performed: necropsies were performed on all animals. Tissues and organs of hte thoracic and abdominal cavities were examined.
Statistics:
No data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no mortalities
Clinical signs:
other: All animals appeared active and healthy during the study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied.
Other findings:
No data

Any other information on results incl. tables

Table 2. Individual body weights and doses

Animal No.

Sex

Dose level

(mg/kg)

Body weight (g)

Dose1

(mL)

Initial

Day 7

Day 14

9096

F

2000

192

219

250

0.55

9137

F

2000

177

201

243

0.51

9262

F

2000

165

189

240

0.47

9289

F

2000

173

192

240

0.50

9335

F

2000

220

233

256

0.63

1: the test substance was administered as a 50 % w/w mixture in distilled waster. Specific gravity - 1.393 g/mL.

Table 3. Individual cage-side observations

Animal No.

Findings

Day of occurrence

All animals

Active and healthy

0 - 14

Table 4. Individual necropsy observations

Animal No.

Tissues

Findings

All animals

All tissues and organs

No gross abnormalities

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the condiitons of the study, the acute oral LD50 pf PeKacid was greater than 2000 mg/kg of body weight in female rats. According to Regulation (EC) No 1272/2008 (EU CLP) potassium pentahydrogen bis(phosphate) (also known as PeKacid) is not considered to be classified.

This study supports the conclusion that sodium and potassium orthophosphates exhibit low systemic toxicity and therefore the study is included to support the read-across argumentation for acute systemic toxicity for the endpoint; 8.5.2 Acute Dermal Toxicity and 8.5.3 Acute Inhalation Toxicity.