Zinc sulfide (ZnS), manganese-doped

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: guidline compliant study, used in EU risk assessment for zinc oxide

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

not reported

Test material

Test material information

Constituent 1

Reference substance name:

Zinc oxide

EC Number:

215-222-5

EC Name:

Zinc oxide

Cas Number:

1314-13-2

Molecular formula:

OZn

IUPAC Name:

oxozinc

Details on test material:

- Name of test material (as cited in study report): zinc oxide Zincweiß Pharma A
- Analytical purity: 99.9%

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

see reference

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

water

Challenge

Route:

other: epidermal

Vehicle:

water

No. of animals per dose:

10 in each test in main study
5 controls in each test

Details on study design:

In a third well-performed maximisation test, conducted according to the same guidelines and with the same experimental design, another analytical grade zinc oxide was tested (Zincweiß Pharma A; purity 99.9%). The only difference with the studies described for purity ZnO 99.69% was the intradermal induction concentration, which was 2% as for Zincweiß Pharma A this was considered the highest concentration that could reproducibly be injected. In this test no skin reactions were evident in both experimental and control animals, hence a 0% sensitisation rate for Zincweiß Pharma A. White staining of the treated skin by the test substance was observed in some animals 24 and 48 hours after challenge

Challenge controls:

see details on study designs

Positive control substance(s):

yes

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

2 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. Group: test group. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitising

Conclusions:

Not sensitising

Executive summary:

In a third well-performed maximisation test, conducted according to the same guidelines and with the same experimental design, another analytical grade zinc oxide was tested (Zincweiß Pharma A; purity 99.9%). The only difference with the previous studies described for zinc oxide of purity 99.69% was the intradermal induction concentration, which was 2% as for Zincweiß Pharma A this was considered the highest concentration that could reproducibly be injected. In this test no skin reactions were evident in both experimental and control animals, hence a 0% sensitisation rate for Zincweiß Pharma A. White staining of the treated skin by the test substance was observed in some animals 24 and 48 hours after challenge.