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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Study period:
12 Aug 2010 - 29 Apr 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
yes
Remarks:
an occlusive dressing was used
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
yes
Remarks:
an occlusive dressing was used
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
adopted in 1998
Deviations:
yes
Remarks:
an occlusive dressing was used
GLP compliance:
yes (incl. QA statement)
Remarks:
Országos Gyógyszerészeti Intézet, National Institute of Pharmacy, Budapest, Hungary

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
EC Number:
247-304-1
EC Name:
Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
Cas Number:
25869-00-5
Molecular formula:
C6FeN6H4N
IUPAC Name:
Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): ammonium iron(3+) hexakis(cyano-C) ferrate(4-)
- Physical state: solid
- Appearance: blue odourless powder
- Analytical purity: 93.6%
- Lot/batch No.: K73-4766
- Expiration date of the lot/batch: 20 Mar 2013
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft., Kartal, Hungary
- Age at study initiation: approximately 11 weeks
- Weight at study initiation: 2792 - 2888 g
- Housing: The animals were housed individually in metal wire rabbit cages (65x65x45 cm).
- Diet: Purina Base - Lap gr. diet for rabbits, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 22.1
- Humidity (%): 53 - 81
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 17 Aug 2010
To: 20 Aug 2010

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Not required, the untreated skin of each animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on back and flanks
- Type of wrap if used: The treated skin was covered with 4 layers of fine medical gauze (open-weave with large holes), held in place with a patch of clear plastic with a surrounding adhesive hypoallergenic plaster. Additionally, the entire trunk of each animal was wrapped with plastic wrap held in place with medical elastic tubing.

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed with water at body temperature.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The dermal application of the test substance resulted in very slight erythema and edema formation (score 1) in one animal at the 1 and 24 h reading time point. The effect reversed within 48 h. No effect on another animal was observed at any time point.
Other effects:
No mortality occurred during the study period. No clinical signs or adverse effects on body weight were observed at any time point.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified