Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
15708-41-05
IUPAC Name:
15708-41-05
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 item 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.