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EC number: 231-912-9 | CAS number: 7778-74-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- 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
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 - 29 April 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 208 ± 9g
- Fasting period before study: 18 hours prior to dosing till 4 hours after dosing
- Housing: polycarbonate cages with stainless steel lid (48x27x20cm); each cage contained autoclaved sawdust (SICSA, Alfortville, France)
- Diet: SSNIFF R/M-H pelleted maintenance diet (ad libitum except for fasting period) SSNIFF Spezialdiaten GmbH, Soest, Germany
- Water : drinking water filtered by a FG Millipore membrane (0.22µm) provided ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70%
- Air changes (per hr): 12 cycles of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr (7:00-19:00)
IN-LIFE DATES: From: 01 April 2008 To: 29 April 2008 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 & 2000 mg/kg
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: solubility
- Lot/batch no. (if required): Not reported
- Purity: purified water prepared at CIT by reverse osmosis
MAXIMUM DOSE VOLUME APPLIED: 2.2 mls
DOSAGE PREPARATION (if unusual): N/A
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: animal welfare reasons as no information on the toxic potential of the test item was available - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females at 300 mg/kg
6 females at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed frequently during the hours following administration of the test item and at least once per day
thereafter; bodyweights recorded just prior to administration of the test item on day 1 and then on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of main organs at necropsy - Statistics:
- No statistical analysis was performed
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities
- Clinical signs:
- other: No clinical signs were noted at 300mg/kg/day, whereas hypoactivity was noted for all animals given 2000mg/kg/day during the 2 hours following treatment.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
- Other findings:
- - Organ weights: N/A
- Histopathology: N/A
- Potential target organs: N/A
- Other observations: None - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was higher than 2000 mg/kg in rats.
- Executive summary:
The acute oral toxicity of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was evaluated in rats according to OECD (No. 423, 17th December 2001) and EC (2004/73/EC, B.1 tris, 29th April 2004) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. Under the experimental conditions of this study, the oral LD0 of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was higher than 2000 mg/kg in rats.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 01 - 29 April 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Justification for type of information:
- In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 208 ± 9g
- Fasting period before study: 18 hours prior to dosing till 4 hours after dosing
- Housing: polycarbonate cages with stainless steel lid (48x27x20cm); each cage contained autoclaved sawdust (SICSA, Alfortville, France)
- Diet: SSNIFF R/M-H pelleted maintenance diet (ad libitum except for fasting period) SSNIFF Spezialdiaten GmbH, Soest, Germany
- Water : drinking water filtered by a FG Millipore membrane (0.22µm) provided ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70%
- Air changes (per hr): 12 cycles of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr (7:00-19:00)
IN-LIFE DATES: From: 01 April 2008 To: 29 April 2008 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 & 2000 mg/kg
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: solubility
- Lot/batch no. (if required): Not reported
- Purity: purified water prepared at CIT by reverse osmosis
MAXIMUM DOSE VOLUME APPLIED: 2.2 mls
DOSAGE PREPARATION (if unusual): N/A
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: animal welfare reasons as no information on the toxic potential of the test item was available - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females at 300 mg/kg
6 females at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed frequently during the hours following administration of the test item and at least once per day
thereafter; bodyweights recorded just prior to administration of the test item on day 1 and then on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of main organs at necropsy - Statistics:
- No statistical analysis was performed
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities
- Clinical signs:
- other: No clinical signs were noted at 300mg/kg/day, whereas hypoactivity was noted for all animals given 2000mg/kg/day during the 2 hours following treatment.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
- Other findings:
- - Organ weights: N/A
- Histopathology: N/A
- Potential target organs: N/A
- Other observations: None - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) was higher than 2000 mg/kg in rats.
Based on the read-across justification the LD50 oral of potassium perchlorate can be considered higher than 2000 mg/kg bw.
Referenceopen allclose all
No deaths and no clinical signs were observed in the three females given 300 mg/kg/day. When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/3 females between day 8 and day 15 (7 g versus 8 g in CIT historical control animals). As this corresponds to a lack less than 1% when considering the final body weight of this animal, it was not considered significant. The body weight gain of the other animals was not affected by treatment with the test item. Dose-level of 2000 mg/kg (three females then confirmation on three other females) no deaths occurred. Hypoactivity was noted in all animals within 2 hours of treatment; (see Table 1 below). When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/3 females between day 1 and day 8 (33 g versus 34 g in CIT historical control animals, returning to normal thereafter) and in another female between day 8 and day 15 (6 g versus 8 g in CIT historical control animals). This minor change in body weight was not considered as significant. The body weight gain of the other animals was not affected by treatment with the test item (Tables 2 & 3 below). At necropsy, no apparent abnormalities were observed in any animal.
Table 1: Individual clinical signs and mortality
Dose level (mg/kg)
|
Time |
Females |
Mortality |
Clinical signs |
300 |
15 min, 1-2hr-4hr - D2 to D15 |
01-02-03 |
No |
None |
2000 (first assay) |
15 min
1 hr
2 hr
4hr- D2 to D15 |
04-05-06
04 05-06
04-05-06
04-05-06 |
No
No No
No
No |
None
Hypoactivity None
Hypoactivity
None
|
2000 (confirmatory assay) |
15 min
1hr – 2 hr
4 hr – D2 to D15 |
08 07-09
07-08-09
07-08-09 |
No No
No
No |
Hypoactivity None
Hypoactivity
None
|
min: minutes
hr: hour
D: day
Table 2: Individual and mean body weight and weekly body weight change of treated rats (g)
Dose level (mg/kg) |
Vol. mL/kg |
Sex |
Animals |
Days |
||||
1 |
(1) |
8 |
(1) |
15 |
||||
300 |
10 |
Female |
01 |
214 |
43 |
257 |
13 |
270 |
02 |
190 |
44 |
234 |
7 |
241 |
|||
03 |
211 |
52 |
263 |
9 |
272 |
|||
|
||||||||
Mean |
205 |
46 |
251 |
10 |
261 |
|||
SD |
13 |
5 |
15 |
3 |
17 |
|||
|
||||||||
2000 (first assay) |
10 |
Female |
04 |
220 |
46 |
266 |
6 |
272 |
05 |
205 |
37 |
242 |
20 |
262 |
|||
06 |
215 |
35 |
250 |
19 |
269 |
|||
|
||||||||
Mean |
213 |
39 |
253 |
15 |
268 |
|||
SD |
8 |
6 |
12 |
8 |
5 |
|||
|
||||||||
2000 (confirmatory assay) |
10 |
Female |
07 |
208 |
43 |
251 |
14 |
265 |
08 |
202 |
35 |
237 |
25 |
262 |
|||
09 |
206 |
33 |
239 |
24 |
263 |
|||
|
||||||||
Mean |
205 |
37 |
242 |
21 |
263 |
|||
SD |
3 |
5 |
8 |
6 |
2 |
|||
|
(1): bodyweight gain
SD: standard deviation
Table 3: Body weight - CIT historical data of control animals dosed (water) by oral route
Volume (mL/kg) |
Sex |
Days |
|||||
|
1 |
(1) |
8 |
(1) |
15 |
||
10 (water) |
Female |
Mean |
196 |
39 |
236 |
16 |
252 |
SD |
7 |
5 |
9 |
8 |
12 |
||
n |
30 |
30 |
30 |
30 |
30 |
(1): bodyweight gain
SD: standard deviation
n: number of animals
No deaths and no clinical signs were observed in the three females given 300 mg/kg/day. When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/3 females between day 8 and day 15 (7 g versus 8 g in CIT historical control animals). As this corresponds to a lack less than 1% when considering the final body weight of this animal, it was not considered significant. The body weight gain of the other animals was not affected by treatment with the test item. Dose-level of 2000 mg/kg (three females then confirmation on three other females) no deaths occurred. Hypoactivity was noted in all animals within 2 hours of treatment; (see Table 1 below). When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/3 females between day 1 and day 8 (33 g versus 34 g in CIT historical control animals, returning to normal thereafter) and in another female between day 8 and day 15 (6 g versus 8 g in CIT historical control animals). This minor change in body weight was not considered as significant. The body weight gain of the other animals was not affected by treatment with the test item (Tables 2 & 3 below). At necropsy, no apparent abnormalities were observed in any animal.
Table 1: Individual clinical signs and mortality
Dose level (mg/kg)
|
Time |
Females |
Mortality |
Clinical signs |
300 |
15 min, 1-2hr-4hr - D2 to D15 |
01-02-03 |
No |
None |
2000 (first assay) |
15 min
1 hr
2 hr
4hr- D2 to D15 |
04-05-06
04 05-06
04-05-06
04-05-06 |
No
No No
No
No |
None
Hypoactivity None
Hypoactivity
None
|
2000 (confirmatory assay) |
15 min
1hr – 2 hr
4 hr – D2 to D15 |
08 07-09
07-08-09
07-08-09 |
No No
No
No |
Hypoactivity None
Hypoactivity
None
|
min: minutes
hr: hour
D: day
Table 2: Individual and mean body weight and weekly body weight change of treated rats (g)
Dose level (mg/kg) |
Vol. mL/kg |
Sex |
Animals |
Days |
||||
1 |
(1) |
8 |
(1) |
15 |
||||
300 |
10 |
Female |
01 |
214 |
43 |
257 |
13 |
270 |
02 |
190 |
44 |
234 |
7 |
241 |
|||
03 |
211 |
52 |
263 |
9 |
272 |
|||
|
||||||||
Mean |
205 |
46 |
251 |
10 |
261 |
|||
SD |
13 |
5 |
15 |
3 |
17 |
|||
|
||||||||
2000 (first assay) |
10 |
Female |
04 |
220 |
46 |
266 |
6 |
272 |
05 |
205 |
37 |
242 |
20 |
262 |
|||
06 |
215 |
35 |
250 |
19 |
269 |
|||
|
||||||||
Mean |
213 |
39 |
253 |
15 |
268 |
|||
SD |
8 |
6 |
12 |
8 |
5 |
|||
|
||||||||
2000 (confirmatory assay) |
10 |
Female |
07 |
208 |
43 |
251 |
14 |
265 |
08 |
202 |
35 |
237 |
25 |
262 |
|||
09 |
206 |
33 |
239 |
24 |
263 |
|||
|
||||||||
Mean |
205 |
37 |
242 |
21 |
263 |
|||
SD |
3 |
5 |
8 |
6 |
2 |
|||
|
(1): bodyweight gain
SD: standard deviation
Table 3: Body weight - CIT historical data of control animals dosed (water) by oral route
Volume (mL/kg) |
Sex |
Days |
|||||
|
1 |
(1) |
8 |
(1) |
15 |
||
10 (water) |
Female |
Mean |
196 |
39 |
236 |
16 |
252 |
SD |
7 |
5 |
9 |
8 |
12 |
||
n |
30 |
30 |
30 |
30 |
30 |
(1): bodyweight gain
SD: standard deviation
n: number of animals
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- According to REACH regulation, Annex VIII, an acute toxicity test should be conducted for at least on other route (inhalative or dermal) in addition to the oral route.
The human exposure by the dermal route is considered to be more likely than by the inhalative route.
Inhalation is unlikely as potassium perchlorate is a solid at room temperature.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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