Dodecairon strontium nonadecaoxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-06-16 to 2010-07-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data generated according to generally valid testing guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

In addition: Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Second revised edition, 2007. Chapter 3.4 Respiratory or Skin Sensitization

Deviations:

yes

Remarks:

During the challenge phase, 75% HCA (v/v) in acetone instead of undiluted HCA was used for topical application in the animals of positive control group. This was to avoid irritation (non-irritant dose at challenge phase) and had no impact on the validity.

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Justification for non-LLNA method:

LLNA-method is only needed for new test plan.

Test material

Test material information

Constituent 1

Reference substance name:

Dodecairon strontium nonadecaoxide

EC Number:

234-685-4

EC Name:

Dodecairon strontium nonadecaoxide

Cas Number:

12023-91-5

Molecular formula:

Fe12O19.Sr

IUPAC Name:

dodecairon(3+) strontium(2+) nonadecaoxidandiide

Details on test material:

- Name of test material (as cited in study report): Strontiumhexaferrite ("Manipermpulver")
- Analytical purity: 100 % industrial strontiumferrite
- Impurities (identity and concentrations): see section 1.2 of the IUCLid5.2-file
- Composition of test material, percentage of components: see section 1.2 of the IUCLid5.2-file
- Lot/batch No.: S16/179/08
- Expiration date of the lot/batch: 12/2999
- Stability under test conditions: stable
- Storage condition of test material: air-conditioned romm temperature, non-sterile

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co. Ltd.; No 4, YangShan Road, Chaoyang District, Beijing, China
- Age at study initiation: Young adults
- Weight at study initiation: 680 - 944 g
- Housing: Conventional guinea pig cage system
- Diet (e.g. ad libitum): LabDiet 5025 Guinea Pig Diet
- Water (e.g. ad libitum): tap
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

water

Induction 2

Concentration / amount:

A gauze patch with approximate area of 6cm2 was loaded with 0.5 g test substance moistened with 80% (v/v) ethanol in water.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

A gauze patch with approximate area of 6cm2 was loaded with 0.5 g test substance moistened with 80% (v/v) ethanol in water.

No. of animals per dose:

20. Plus 10 each in negative and positive control group.

Details on study design:

All animals were shaved on the back prior to the application. A gauze patch with approximate area of 6cm2 was loaded with 0.5 g test substance moistened with 80% (v/v) ethanol in water and applied topically to the shaved region of each animal in test group.
The gauze patch was held with an occlusive dressing secured by a surgical tape around the torso of the animal. The patch and dressing will be removed after 6-hour exposure.
In the negative and positive control group, the topical application was conducted in the same way as the test group; except that the gauze patch was fully loaded with negative control substance, i.e. 80% (v/v) ethanol in water or positive control substance, i.e. undiluted HCA, respectively.
The same application was repeatedly carried out on the same test area (cleared of hair if necessary) of each animal. The whole induction phase is outlined as follows:

Group Test Negative control Positive control
Date 16 Jun 2010 (Day 0)
22 Jun 2010 (Day 6)
23 Jun 2010 (Day 7)
24 Jun 2010 (Day 8)
29 Jun 2010 (Day 13)
30 Jun 2010 (Day 14)
01 Jul 2010 (Day 15)
Administration Topical application
Number of animal used 20 10 10
Dose level 0.5 g test substance loaded on an approximate 6 cm2 gauze patch and moistened with 200 µl 80% (v/v) ethanol in water approximate 6 cm2 gauze patch saturated with 500 µl 80% (v/v) ethanol in water approximate 6 cm2 gauze patch saturated with 500 µl undiluted HCA
Exposure period 6 hours
Dose Interval Once on above stated date


Challenge - topical application

Group Test Negative control Positive control
Date 14 Jul 2010 (Day 28)
Administration Topical application
Number of animal used 20 10 10
Dose level 0.5 g test substance loaded on an approximate 6 cm2 gauze patch and moistened with 200 µl acetone
approximate 6 cm2 gauze patch saturated with 500 µl 75% (v/v) HCA in acetone*
Exposure period 6 hours
Dose Interval Once on above stated date
Note: * During the induction phase, there was mild-to-moderate irritation after undiluted HCA topical application in animals of positive control group. Therefore, in challenge phase, 75% (v/v) HCA in acetone instead of undiluted HCA was used for topical application in the animals of positive control group to avoid irritation (non-irritant dose).

Positive control substance(s):

yes

Remarks:

HCA = α-Hexylcinnamaldehyde

Results and discussion

Positive control results:

Positive control after 24 h after 48 h
219103186-01-00-PC1 1 0
219103186-01-00-PC2 2 2
219103186-01-00-PC3 2 1
219103186-01-00-PC4 2 2
219103186-01-00-PC5 1 0
219103186-01-00-PC6 2 1
219103186-01-00-PC7 2 1
219103186-01-00-PC8 1 1
219103186-01-00-PC9 1 1
219103186-01-00-PC10 2 1

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 g of the test substance

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No adverse effect was observed on all test animals during the observation period.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 g of the test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 g of the test substance

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No adverse effect was observed on all test animals during the observation period.

Remarks on result:

other: see Remark

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 g of the test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

500 µl 80 % (V/V) ethanol in water

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No adverse effect was observed on all test animals during the observation period.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 500 µl 80 % (V/V) ethanol in water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

500 µl 80 % (v/v) ethanol in water

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No adverse effect was observed on all test animals during the observation period.

Remarks on result:

other: see Remark

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 500 µl 80 % (v/v) ethanol in water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..

Results 5

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

500 µl undiluted HCA

No. with + reactions:

10

Total no. in group:

10

Clinical observations:

No adverse effect was observed on all test animals during the observation period.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 500 µl undiluted HCA. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..

Results 6

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

500µl undiluted HCA

No. with + reactions:

8

Total no. in group:

10

Clinical observations:

No adverse effect was observed on all test animals during the observation period.

Remarks on result:

other: see Remark

Remarks:

Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 500µl undiluted HCA. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Based on the above results, strontium ferrite (“Manipermpulver”) did not produce skin sensitization in guinea pigs.
Strontium ferrite is to be considered as non-sensitizing to the skin. Classification is not required.

Executive summary:

The skin senzitisation potential of strontium ferrite was assessed in a test according to OECD 406 and UN-GHS. 20 animals (guinea pigs) were used for testing strontium ferrite, 10 anaimals 10 were in the negative and positive control group. The positive control group was exposed to undiluted HCA = α-Hexylcinnamaldehyde.

Observation of skin reactions was conducted at 24 and 48 hours after removal of the challenge patch. The skin reactions were recorded according to the grades shown in Magnusson and Kligman Grading Scale as follows:

Skin reaction	Grades
No visible change Discrete or patchy erythema Moderate and confluent erythema Intense erythema and swelling	0 1 2 3

 The average Magnusson and Kligman grade of animals in the negative control group is 0 (i.e. <1) during 24 and 48 hrs observations.

 The percentage of animals shown Magnusson and Kligman grades of 1 or greater in test group is 0% (i.e. <15%) during 24 and 48 hrs observations.

 The percentage of animals shown Magnusson and Kligman grades of 1 or greater in positive control group is 100% (i.e. >15%) during 24 and 48 hrs observations.    

Based on the above results, strontium ferrite (“Manipermpulver”) did not produce skin sensitization in guinea pigs.

Strontium ferrite is to be considered as non-sensitizing to the skin. Classification is not required.