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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Public available literature without indication of guideline and GLP
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hypochlorite
EC Number:
231-668-3
EC Name:
Sodium hypochlorite
Cas Number:
7681-52-9
Molecular formula:
ClO.Na
IUPAC Name:
sodium hypochlorite
Details on test material:
chlorine - bleaching solution (12.5 % active chlorine)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
The testing of the acute oral toxicity of the product, chlorine - bleaching solution (12.2% active chlorine), was conducted on 5 groups, each containing 10 male wistar rats with a mean bodyweight of 201 g (fasted weight). The rats were deprived of food 18 hours before administration. Food was provided again 3 hours after administration.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The product was administered – once by the gavage - in aqueous preparations at rising concentrations. Aqua dest. was used as a diluent. The volume administered, 20 ml/kg of bodyweight per application, was kept constant.
Doses:
5.01; 7.94; 8.64; 9.3; and 10.0 g/kg bw based on 12.5 % chlorine solution
No. of animals per sex per dose:
10 male wistar rats
Control animals:
no
Details on study design:
The observation
period after treatment was 14 days.
Statistics:
The LD50 value was calculated statistically, using the method according to Litchfield and Wilcoxon.

Results and discussion

Preliminary study:
no preliminary test
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
626 mg/kg bw
Remarks on result:
other: NaClO as av. Cl2
Sex:
male
Dose descriptor:
LD50
Effect level:
1 100 mg/kg bw
Remarks on result:
other: NaClO as av. Cl2
Mortality:
The deaths observed occurred in most cases within 24 hours after application.
Clinical signs:
To varying degrees depending on dosage, the following were observed as symptoms of toxicity: bristled fur, mild to heavy sedation, diarrhoea, ataxia and accelerated breathing.
Body weight:
not reported
Gross pathology:
Both the rats that had died and those killed with chloroform at the end of the 14-day observation period were necropsied. During the necropsy, the following changes to the inner organs were found: severe accumulation of gas in the stomach and intestine, swelling of the liver and gastritis and enteritis of the blood.
Other findings:
none

Any other information on results incl. tables

The LD50 and LD0 values were calculated as follows:

LD50= 12.5% (% of available Cl2 in sol.) x 8.83 (g/kg BW LD50 of the sol. to male rat) = 1.1 g/kg BW (LD50 as available Cl2) = 1100 mg/kg BW NaClO as av. Cl2

LD0= 12.5% (% of available Cl2 in sol.) x 5.01 (g/kg LD50 of the sol. to male rat) = 0.626 g/kg BW (LD50 as available Cl2) = 626 mg/kg BW NaClO as av. Cl2

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The LD50 and LD0 values were calculated as follows:
LD50= 12.5% (% of available Cl2 in sol.) x 8.83 (g/kg BW LD50 of the sol. to male rat) = 1.1 g/kg BW (LD50 as available Cl2) = 1100 mg/kg BW NaClO as av. Cl2
LD0= 12.5% (% of available Cl2 in sol.) x 5.01 (g/kg LD50 of the sol. to male rat) = 0.626 g/kg BW (LD50 as available Cl2) = 626 mg/kg BW NaClO as av. Cl2
Executive summary:

An oral LD50 of 8.8 g/kg in rats was quoted for a 12.5% bleach solution (based on available chlorine). Five groups of 10 male Wistar rats each were given 20 ml/kg bw of a dilution of chlorine bleach containing 12.5% available chlorine. During the observation period of 14 days, the following symptoms of toxicity were recorded: ungroomed fur, light to moderate sedation, diarrhea, ataxia, and increased breathing of differing severity. The deaths observed occurred in most cases within 24 hours after application. Pathology upon dissection showed strong gas accumulation in the stomach and intestines, swelling of the liver, bleeding gastritis and enteritis. There were no symptoms noted in the animals that survived. The LD50 was determined to be 8.83 (8.2 – 9.51) g/kg bw, and the NOAEL was found to be 5.01 g/kg bw, all based on the 12.5% available chlorine solution. The LD50 and LD0 values were calculated as follows:

LD50= 12.5% (% of available Cl2 in sol.) x 8.83 (g/kg BW LD50 of the sol. to male rat) = 1.1 g/kg BW (LD50 as available Cl2) = 1100 mg/kg BW NaClO as av. Cl2

LD0= 12.5% (% of available Cl2 in sol.) x 5.01 (g/kg LD50 of the sol. to male rat) = 0.626 g/kg BW (LD50 as available Cl2) = 626 mg/kg BW NaClO as av. Cl2

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