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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP compliance, no study period.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breed
- Age at study initiation: male: 52 days; female: 70 days
- Weight at study initiation: 165 to 185 g
- Housing: individually in Makrolon cages
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 0.5°C
- Humidity (%): 55 % ± 5 %:
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Hydroxypropyl-Methylcellulose E 4 M
Details on oral exposure:
Disodium peroxodisulfate was dissolved in 0.8 % aqueous Hydroxypropyl-Methylcellulose E 4 M and applied per gavage in a constant volume of 10 ml/kg bw.
Doses:
215, 464, 562, 681, 825, 1000, 1210, 1470 mg/kg p.o.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 4 weeks
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortalities
Statistics:
According to Litchfield and Wilcoxon.

Results and discussion

Preliminary study:
NA
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Remarks on result:
other: 24 h
Sex:
male
Dose descriptor:
LD50
Effect level:
930 mg/kg bw
Remarks on result:
other: 14 d
Sex:
female
Dose descriptor:
LD50
Effect level:
1 000 mg/kg bw
Remarks on result:
other: 24 h
Sex:
female
Dose descriptor:
LD50
Effect level:
920 mg/kg bw
Remarks on result:
other: 14 d
Sex:
male
Dose descriptor:
LD0
Effect level:
464 mg/kg bw
Remarks on result:
other: 14 d
Sex:
female
Dose descriptor:
LD0
Effect level:
562 mg/kg bw
Remarks on result:
other: 14 d
Mortality:
See table below at Sect. "Remarks on results"
Clinical signs:
Sedation, ataxia, dyspnoea (464 mg/kg), diarrhoea, muscular hypotension, mydriasis (562 mg/kg), reduced feed intake, face-down position (681 mg/kg)
Body weight:
no data
Gross pathology:
Dead animals: liver- and kidney-parenchyma pale, partly sabulous surface structure, distinct haemorrhage and ulceration on gastric wall and intestinal wall, gastric wall and intestinal wall thin-walled, liver tissue green-brown coloured.
surviving animals: without specific pathologic findings; 2 animals liver surface gross structured
Other findings:
no data

Any other information on results incl. tables

Mortality:

Dose [mg/kg p.o.]

24 h

14 d

 

Male

Female

Male

Female

215

0

0

0

0

464

0

0

0

0

562

0

0

0

0

681

0

0

1

1

852

3

2

5

5

1000

1

5

2

7

1210

5

7

9

7

1470

7

9

10

10

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
LD50-values of 930 mg/kg bw (males) and 920 mg/kg bw (females) were determined after a 14 days observation period. Corresponding LD0 values of 464 mg/kg in male rats and 562 mg/kg in female rats were revealed. Based on the obtained results disodium persulfate was classified and labelled Xn, R22 (harmful if swallowed) according to Directive 67/548/EEC (DSD) and as toxic cat. 4 H302 (harmful if swallowed) according to Regulation 1272/2008/EC (CLP).
Executive summary:

Disodium persulfate was tested for toxicity by oral application in male and female Sprague Dawley rats. No guideline was specified. Ten male and ten female Sprague-Dawley rats per group were dosed with 215, 464, 562, 681, 825, 1000, 1210 and 1470 mg/kg bw disodium persulfate and were observed for 4 weeks. Clinical signs and mortalities were recorded. All animals were subjected to gross autopsy after termination of the study. No animal died in the lowest dose group (215 mg/kg bw), two rats (one male and one female rat) died in the intermediate dose group (681 mg/kg bw) and all rats died in the highest dose group (1470 mg/kg bw). Death occurred within 60 minutes until 6 days after application. Surviving animals had recovered after 48 hours after application. Clinical signs included sedation, dyspnoea, diarrhoea, muscular hypotension, reduced feed intake and face-down position. LD50-values of 930 mg/kg bw (males) and 920 mg/kg bw (females) were determined after a 14 days observation period and corresponding LD0 values of 464 mg/kg in male rats and 562 mg/kg in female rats were revealed.