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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.