Registration Dossier
Registration Dossier
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EC number: 231-959-5 | CAS number: 7782-50-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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:
- 1 978
- 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
- 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; 6/15/78Pale yellow liquid
Constituent 1
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:
- other: Male/female 7.5 g/kg bw:Decreased activity, backs very red and very swollen, nasal discharge, soft stools, ataxia, urinary incontinenceMale/female 10.4 g/kg bw:Decreased activity, backs burned and swollen, nasal discharge, ataxia, urinary incontinence, la
- Gross pathology:
- Male/female 7.5 g/kg bw:Lungs: slightly pale, Spleen: dark, Kidneys: pale, Intestines: full, Bladder: full, Stomach: fullMale/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: fullMale/female 14.42 g/kg bw:Lungs: pale, Liver: mottled, Spleen: dark and granular, Kidneys: pale, Intestines: full, Bladder: full, Stomach: fullMale/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 informationCriteria 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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