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EC number: 231-668-3 | CAS number: 7681-52-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Deficiencies: Yes. Individual animal data not available, separate data for erythema and oedema not reported, total applied volume not reported. Although some aspects of the study do not meet up-to-date standards, the results are reliable and sufficient for risk assessment. New studies are not required and should not be conducted due to animal welfare considerations.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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
Hypochlorite bleach
Purity: 5.0-5.25 % (w/w)
Constituent 1
Test animals
- Species:
- other: rabbit, guinea pig
- Strain:
- other: Albino, Hartley
- Details on test animals or test system and environmental conditions:
- Young adult, weight not stated
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Concentration: 5.3 % active substance
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 1 month (for most subjects).
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4/24/48 h
- Score:
- 1.2
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rabbit
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4/24/48 h
- Score:
- 0.8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: Guinea Pig
- Other effects:
- No findings
Any other information on results incl. tables
Species |
Mean scores1 |
Primary irritation index2 |
Tissue destruction |
Irritancy judgment3 |
||
Intact |
Abraded |
Intact |
Abraded |
|||
Rabbit |
1.0 |
1.3 |
1.2 |
0/6 |
0/6 |
Slight |
Guinea pig |
0.3 |
1.2 |
0.8 |
0/6 |
0/6 |
Slight |
1 Sum of mean erythema and edema scores (on a 0-4 scale) at 4, 24 and 48 hours.
2 Primary irritation index: Average of mean scores for intact and abraded sites.
3 Irritancy judgements are based on the PII scores as follows: 0-0.4 = negligible, 0.5-1.9 = slight, 2.0-4.9 = moderate, 5.0-8.0 = severe, tissue destruction or irreversible change = corrosion (Draize, 1959).
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Hypochlorite bleach, 5.25 %, was slightly irritant in rabbits and guinea pigs under the conditions described in the study. All symptoms were reversible.The mean score for intact human skin was found to be 3.9. However, since no differentiation was made between erythema and edema (sum of both
was listed), no classification can be obtained for the irritant properties of sodium hypochlorite on human skin. - Executive summary:
- MATERIALS
AND METHODS:
Hypochlorite bleach, containing% of sodium hypochlorite, was tested for its skin irritancy in six rabbits and six guinea pigs according to the revised FHSA procedure as proposed by the FDA in 1972. The test material was applied to intact and abraded skin and occluded with a patch for 4 hours. Sites were evaluated for erythema and edema24 and 48 hours and were scored according to the descriptive scales in the proposed revision of the test procedure; primary irritation indices (PII) were calculated by averaging the scores for all test sites. Most subjects were reexamined after 1 month to see whether any delayed reactions had occurred.
RESULTS AND DISCUSSION:
Hypochlorite bleach,%, was slightly irritant in rabbits and guinea pigs under the conditions described in the study. All symptoms were reversible.
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