Registration Dossier
Registration Dossier
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EC number: 231-668-3 | CAS number: 7681-52-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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. Test material identification missing. No reliability check reported. Although some aspects of the study do not meet up-to-date standards, the results are reliable and sufficient for hazard assessment. New studies are not required and should not be conducted due to animal welfare considerations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- A reliability check was not reported.
- GLP compliance:
- no
- Type of study:
- Buehler test
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
ECM BTS 730 E2050.01
Clear blue-green liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Age at study initiation: Approximately 6 weeks
Weight at study initiation: 316-402 g (males), 293-352 g (females)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- for induction: used as delivered
for challenge: 40 % (v/v) in water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- for induction: used as delivered
for challenge: 40 % (v/v) in water
- No. of animals per dose:
- 10 per sex in test groups
5 per sex in control groups - Details on study design:
- 1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge 40 % occlusive epicutaneous
Challenge schedule: 13 days after third induction (day 28 of the study).
Concentrations used for challenge: 40 % in distilled water
Rechallenge: No
Scoring schedule: 24h, 48h after challenge - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive controls
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see Remarks section
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see Remarks section.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- see Remarks section
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see Remarks section.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
The primary irritancy of the test material was assessed by exposing four naive animals to dermal applications at concentrations of 3, 10, 30 and 100 % (v/v) in distilled water. As erythema developed after the test group had been subject to application of undiluted test material at each phase of the induction procedure, the irritancy of the test material was re-assessed before the challenge concentration was selected. Four naive animals received single occluded dermal applications of 10, 20, 40 and 80 % (v/v) in distilled water. The concentrations for the induction and challenge procedure were 100 and 40 % (v/v), respectively.
Results of test
24h after challenge: 0/20 animals showed signs of allergic reactions.48h after challenge: 0/20 animals showed signs of allergic reactions.
Other findings:
8 animals lost weight until week 2, one male animal died. All animals were healthy during the third, fourth and final week of the study. Occluded application of the undiluted test material to the same dermal test site on three occasions during the induction procedure resulted in increased incidence and severity of erythematous reaction to treatment on each successive application.
Overall result
There were no erythematous responses to challenge with 40 % (v/v) solutions of the test material in distilled water in either test group or the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Apart from transient body weight losses in week two and a single case of mortality all animals appeared to be healthy throughout the study. Occluded application of the undiluted test material to the same dermal test site on three occasions during the induction procedure resulted in increased
incidence and severity of erythematous reaction to treatment on each successive application.
There were no erythematous responses to challenge with 40 % (v/v) solutions of the test material in distilled water in either test group or the control group.
The test material is not considered to be skin sensitising.
Although the documentation appears to be of limited quality the applicant is of the opinion that all relevant data are available, all major issues concerning the sensitisation potential of sodium hypochlorite are addressed and the annex point is sufficiently covered by this study.
The test material is considered to be not skin sensitising. - Executive summary:
- MATERIALS AND METHODS:
10 male and 10 female Dunkin-Hartley guinea-pigs were used for the evaluation of sensitising properties of the test material according to the procedure by Buehler. The undiluted material was used for the induction procedures, while a 40 % (v/v) dilution in distilled water was prepared for the challenge.
Induction procedure: Skin (left shoulder) of animals was shaved on the day prior to treatment. Closed patches were applied to the dermal test sites once each week for three weeks. On each occasion, 0.4 mL of a freshly prepared suspension of the test material was applied to a double layer of open-weave gauze overlying the dermal test site. The gauze was held in place with occlusive plaster strips. Control animals were untreated during the induction period.
Challenge procedure: Challenge of the test and control groups was carried out 13 days after the third induction. A six-hour occlusive dressing was applied to a previously untreated site on the right flank. The challenge sites were depilated approximately 22 hours after challenge by application of a cream of calcium thioglycolate. Two hours and one day after depilation the exposed sites were examined for incidence and severity of erythematous reactions to treatment.Results and discussion:Apart from transient body weight losses in week two and a single case of mortality all animals appeared to be healthy throughout the study. Occluded application of the undiluted test material to the same dermal test site on three occasions during the induction procedure resulted in increased incidence and severity of erythematous reaction to treatment on each successive application. There were no erythematous responses to challenge with 40 % (v/v) solutions of the test material in distilled water in either test group or the control group. The test material is not considered to be skin sensitising. Although the documentation appears to be of limited quality the applicant is of the opinion that all relevant data are available, all major issues concerning the sensitisation potential of sodium hypochlorite are addressed and the annex point is sufficiently covered by this study.
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