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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, but good documentation. Method similar to EU or OECD guidelines.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.40
Deviations:
not specified
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:
Sodium hypochlorite:
Batch A; 6/15/78
Pale yellow liquid

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: males 2.65-3.79 kg, females 2.40-4.05 kg
- Acclimation period: yes

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
7.5, 10.4; 14.42 and 20.0 g/kg bw
No. of animals per sex per dose:
4 males and 4 females
Control animals:
no
Details on study design:
The acute dermal toxicity study (single exposure) was conducted on adult albino rabbits selected from healthy, acclimated animals, as described in 16 CFR 1500.40.
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
14 420 mg/kg bw
Sex:
male/female
Dose descriptor:
other: LOAEL
Effect level:
20 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Mortality:
No mortality in dose levels 7.5, 10.4, and 14.42 g/kg bw. 2 of 8 animals died on day 1 and 2 after application in the high dose group (20 g/kg bw).
Clinical signs:
Male/female 7.5 g/kg bw:
Decreased activity, backs very red and very swollen, nasal discharge, soft stools, ataxia, urinary incontinence

Male/female 10.4 g/kg bw:
Decreased activity, backs burned and swollen, nasal discharge, ataxia, urinary incontinence, lacrimation

Male/female 14.42 g/kg bw:
Decreased activity, backs badly burned and swollen, nasal discharge, ataxia, urinary incontinence, diarrhea, rales

Male/female 20 g/kg bw:
Decreased activity, backs badly burned and swollen, nasal discharge, ataxia, urinary incontinence, sores on mouth, bloody nasal discharge, bloody salivation

Body weight:
No diffeneces in body weight observed between initial values and after 14 days.
Gross pathology:
Male/female 7.5 g/kg bw:
Lungs: slightly pale, Spleen: dark, Kidneys: pale, Intestines: full, Bladder: full, Stomach: full

Male/female 10.4 g/kg bw:
Lungs: pale, Liver: dark (males), Spleen: dark (females) dark and granular (males), Kidneys: pale, Intestines: full, Bladder: full, Stomach: full

Male/female 14.42 g/kg bw:
Lungs: pale, Liver: mottled, Spleen: dark and granular, Kidneys: pale, Intestines: full, Bladder: full, Stomach: full

Male/female 20 g/kg bw:
Lungs: pale, Liver: dark and mottled, Spleen: dark and granular, Kidneys: pale, Intestines: pale, Bladder: full, Stomach: full, Chest Cavity: contained bloody liquid
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of sodium hypochlorite after dermal application to rabbits was determined to be > 20 g/kg bw.
Executive summary:

In an acute dermal toxicity study, groups of adult) albino rabbits (4/sex) were dermally exposed to sodium hypochlorite (12.5 %) in water at doses of 7.5, 10.4; 14.42 and 20.0 g/kg bw. Animals then were observed for 14 days.

Dermal LD50 > 20 g/kg bw

No mortality in dose levels 7.5, 10.4, and 14.42 g/kg bw. 2 of 8 animals died on day 1 and 2 after application in the high dose group (20 g/kg bw). Sodium hypochlorite is of low toxicity based on males and females.

Major clinical signs observed:

Decreased activity, backs badly burned and swollen, nasal discharge, ataxia, urinary incontinence, sores on mouth, bloody nasal discharge, bloody salivation

Major pathological findings observed:

Lungs: pale, Liver: dark and mottled, Spleen: dark and granular, Kidneys: pale, Intestines: pale, Bladder: full, Stomach: full, Chest Cavity: contained bloody liquid

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