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Toxicological information

Skin irritation / corrosion

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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:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
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
Hypochlorite bleach
Purity: 5.0-5.25 % (w/w)

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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