Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
The availability of this data obviates the need to conduct an in-vitro study,
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
1982

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
Justification for non-LLNA method:
The study was already available.

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 hypochloriteECM BTS 730 E2050.01Clear blue-green liquid

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 weeksWeight 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 groups5 per sex in control groups
Details on study design:
1st application: Induction undiluted occlusive epicutaneous2nd application: Challenge 40 % occlusive epicutaneousChallenge schedule: 13 days after third induction (day 28 of the study).Concentrations used for challenge: 40 % in distilled waterRechallenge: NoScoring 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

Results of pilot study

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.

Categories Display