Iron tris(phosphinate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

secondary source

Title:

Ferric phosphate- Toxicological evaluation

Author:

European Food Safety Authority (EFSA)

Year:

2013

Bibliographic source:

Ferric phosphate - RAR - Vol. 3, 2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

To assess the extent of irritation or corrosion caused by Test chemical to rabbit skin

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Iron orthophosphate

EC Number:

233-149-7

EC Name:

Iron orthophosphate

Cas Number:

10045-86-0

Molecular formula:

Fe.H3O4P

IUPAC Name:

Ferric phosphate

Test material form:

solid: crystalline

Details on test material:

Name of the test compound: Ferric orthophosphate
Molecular formula: FePO4
Molecular weight: 154 g/mo/l
Substance type: Inorganic
Physical State: Solid
Lot/Batch no.: 105668
Purity: Minimum 24.8 % Fe
Stability of test compound: Stable under recommended storage conditions (room temp. in the dark)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Milli-U water used to moisten the substance to ensure good skin contact.

Controls:

not specified

Amount / concentration applied:

0.5 g applied undiluted. Milli-U water used to moisten the substance to ensure good skin contact.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 male New Zealand White rabbits

Details on study design:

Details on study design
TEST SITE
- Area of exposure: clipped dorsum
- % coverage: no data available
- Type of wrap if used: no data available


SCORING SYSTEM: no data available

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritation was observed at any of the treated dermal sites on three rabbits exposed for 4 hours to test chemical. There was no evidence of a corrosive reaction and no indications of dermal staining by the test substance. No mortalities occurred and there were no signs of systemic toxicity recorded.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

No irritation was observed at any of the treated dermal sites on three rabbits exposed for 4 hours to the test chemical. There was no evidence of a corrosive reaction and no indications of dermal staining by the
test substance. No mortalities occurred and there were no signs of systemic toxicity recorded.
Based on these observations the test chemical can be considered to be not irritating to rabbit skin.

Executive summary:

A study was performed to assess the extent of irritation or corrosion caused by test chemical to rabbit skin. The study was performed according toOECD 404 andEC Commission Directive 92/69/EEC, Method B4, Acute Toxicity – Skin irritation.0.5 g of test chemical was applied undiluted to the clipped dorsum skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours. Milli-U water used to moisten the substance to ensure good skin contact. Dermal observations were made for up to 72 hours.

No irritation was observed at any of the treated dermal sites on three rabbits exposed for 4 hours to test chemical. There was no evidence of a corrosive reaction and no indications of dermal staining by the test substance. No mortalities occurred and there were no signs of systemic toxicity recorded.Based on these observations the test chemical can be considered to be not irritating to rabbit skin.