Triiron bis(orthophosphate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-12-13 to 2016-01-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2015-07-28

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triiron bis(orthophosphate)

EC Number:

239-018-0

EC Name:

Triiron bis(orthophosphate)

Cas Number:

14940-41-1

Molecular formula:

Fe.2/3H3O4P or Fe3(PO4)2

IUPAC Name:

triiron bis(orthophosphate)

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation: light grey powder

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 15 - 25 °C, tightly closed

Test animals

Species:

rabbit

Strain:

other: Zika

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kaninchenbetrieb Kock, Warnkenhagen, Germany
- Age at study initiation: 13 (one rabbit) and 18 weeks old (two rabbits)
- Weight at study initiation: 3.41 to 3.96 kg
- Housing: single-caged; during the exposure time the rabbits were kept in a restrainer avoiding ingestion or inhalation of the test substance and avoiding access to the patch by the animal.
- Diet: conventional laboratory diet (a half-and-half blend of "Holstenstolz Kaninchenverbrauchsfutter Z, Type 038" and "Rabbit maintenance, MuesliMash")
- Water (ad libitum): tap water (drinking quality)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C (± 3 °C)
- Relative humidity: 30 - 70 %
- Air changes: 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance moistened with vehicle

VEHICLE
- Amount(s) applied (volume or weight with unit): 500 µL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 female rabbits

Details on study design:

INITIAL AND CONFIRMATORY TEST
Prior to the initial test the pH of the test substance in water (saturated, sedimented suspension, 5.55 % w/v) was determined (pH = 7.46).
The in vivo test was performed initially using one animal. The first patch was removed after three minutes. No serious skin reaction was observed, therefore a second patch was applied at a different site and removed after one hour. No serious skin reaction was observed, therefore a third patch was applied at a different site and removed after four hours.
Because of a negative response after the initial test, two additional animals were exposed simultaneously. A single patch was applied to both animals for 4 hours.

TEST SITE
- Area of exposure: dorsal area of the trunk (area: approx. 6 cm²)
- Type of wrap if used: test substance was applied to the clipped skin and covered with a gauze patch (compress for operation, 8-fold), which was held in place with a non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed, using water without altering the existing response or the integrity of the epidermis
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS (4 hour application time)
immediately (initial test only) as well as 1, 24, 48, and 72 hours after removal of the patch

SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

amimal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

aninmal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No evidence of skin irritation/corrosion was noted during the study.

Other effects:

- Other adverse systemic effects: at the daily observation the animals did not show any other visible clinical symptoms.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.