Reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In accordance with Regulation (EU) 2016/863, preamble (7), adequate information from existing in vivo skin irritation study used to fulfil the standard information requirement point 8.1 Regulation (EC) No 1907/2006.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-02-06 to 1991-02-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

EEC Directive 84/449 EEC, EEC Publication No. L251, September 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

dialuminium(3+) tetracalcium hexaoxidandiide phosphonate

EC Number:

915-069-0

Molecular formula:

not applicable

IUPAC Name:

dialuminium(3+) tetracalcium hexaoxidandiide phosphonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Selection of animals: Animals for test were selected from stock on the basis of background history. Each animal may have been used on a maximum of 3 previous occasions (in up to 2 eye irritation studies - one test each eye, possibly 1 skin irritation study). No significant response has been noted on any previous occasion. Only an area of flank skin not used previously treated was used for the test.
- Rational for selection: To minimise animal usage without compromising sudy integrity.
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: 2793-3134 g
- Housing: Individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approximately 100 g per day
- Water: tap-water diluted with decalcified water ad libitum
- Acclimation period: At least five days before start of treatment under test conditions.


ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 55 %
- Air changes (per hr): 15
- Photoperiod: Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: The contralateral flank was similarly prepared (but without test article and vehicle) to act as procedural control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): The powdery test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal skin.

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were assessed at approximately 60 minutes, 24, 48 and 72 hours after the removal of the dressings and test substance.

Number of animals:

3

Details on study design:

TEST SITE
- Preparation: Approximately 24 hours before treatment, the dorsal fur was shaved with electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
- Area of exposure: 2x3 cm
- Test substance application: On test day 1, 0.5 gram of the moistened test substance was applied to the intact skin of the shaved area on one flank, using a Metalline patch (2x3 cm, Lohman, Neuwied, W.-Germany), mounted to Micropore tape (3M, St. Paule, USA).
- Type of wrap if used: The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the application period, the dressing was removed and the remaining test article removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours

SCORING SYSTEM: numerical scoring system according to Draize as given in the guidelines

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no erythema occured

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no erythema occured

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no erythema occured

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no edema occured

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no edema occured

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no edema occured

Irritant / corrosive response data:

Without exception, all individual and mean scores for erythema and edema were 0 at every observation time (55 minutes, 24, hours, 48 hours, and 72 hours).

Any other information on results incl. tables

Under the conditions of this study, no skin irritation was caused by the test substance in all three animals.

In the area of application, no staining of the treated skin by the test substance was observed.

No corrosive effect occurred on the skin in all three rabbits.

No signs of systemic intoxication were observed during the study period.

The test substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: Regulation (EC) No 1272/2008 (EU GHS)

Conclusions:

According to the criteria for classification and labelling of Regulation (EC) No 1272/2008, the test substance does not need to be classified for skin corrosion/irritation.

Executive summary:

In a primary dermal irritation study according to OECD Guideline No. 404, May 12, 1981 and EEC Directive 84/449/EEC, Part B.4, September 1984, 3 young adult New Zealand white rabbits were dermally exposed to 0.5 g of substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) in water to approximately 6 cm² of body surface area. Tests sites were covered with a semiocclusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the numerical scoring system according to Draize as given in the guidelines.

Without exception, all individual and mean scores for erythema and edema were 0 at every observation time (primary irritation index = 0).

In this study, substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) is not a dermal irritant.