Sodium calcium edetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium feredetate

EC Number:

239-802-2

EC Name:

Sodium feredetate

Cas Number:

15708-41-5

IUPAC Name:

iron(3+) sodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Constituent 2

Reference substance name:

FeNAEDTA

IUPAC Name:

FeNAEDTA

Details on test material:

Product brand: Sigma
Lot: 016K0107
Iron by ICP-AES: 14.4%
Sodium by ICP-AES: 6.1%
EDTA content: 69.9%

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT, 24601 Löhndorf, germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.8 - 2.3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 60 per hour
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: 2. To: 6.July 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/animal

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: gauze patch


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

animal: one animal

Time point:

other: 1 hour

Score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

Very slight erythema (grade 1) was observed in one animal at 1 h after removal of the patch. There were no further skin reactions and no systemic adverse effects.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test iterm is not irritating to the skin.

Executive summary:

In a skin irritation study according to OECD guideline 404 a dose of 500 mg FeNaEDTA was applied to the shaved skin of three male rabbits for 4 hours. Very slight erythema was noted for one animal at 1 hour after patch removal. No other skin effects or systemic effects were noted during the observation period of 72h.