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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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:
tris(lambda2-iron(2+)) diphosphate
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
amimal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
aninmal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
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.