Registration Dossier
Registration Dossier
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EC number: 283-044-5 | CAS number: 84539-55-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-09-13 to 1993-09-24
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
- EC Number:
- 283-044-5
- EC Name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
- Cas Number:
- 84539-55-9
- Molecular formula:
- non specified (UVCB substance)
- IUPAC Name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
- Details on test material:
- - Test article: CGA65047 SG 100, (A-5787 A); identical to FeNaEDDHA
- Additional specification: Sesquestrene 138 Fe 100 SG
- Physical state: granules; miscible in water
- Analytical purity: 100% (UVCB)
- Lot/batch No.: P.201845
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2270 zo 2340 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum):ad libitum, standard rabbit pellet-Nafag No.814
- Water (e.g. ad libitum):ad libitum, fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: a control gauze patch was applied to the contrlateral flank
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test article moistened with distilled water - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: the patches were loosely covered with an aluminum foil (approx. 36 cm2) and helf in place by an adhesive tape (Isoplast)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Individual skin reaction scores
|
||||||
|
ERYTHEMA |
EDEMA |
||||
animal no. |
624/MCF/TF |
622/MCF/TF |
362/M CF/TF |
624/MCF/TF |
622/MCF/TF |
362/MCF/TF |
after 1 hr. after 24 hrs. after 48 hrs. after 72 hrs. |
0/0 0/0 0/0 0/0 |
0/* 0/0 0/0 0/0 |
0/* 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 |
0/0 0/0 0/0 0/0 |
mean 24-72 hrs |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
CF = control flank
TF = test flank
M = male
* = erythema not evaluable because of brown staining (substance related)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Application of FeNAEDDHA to the rabbit skin can be designated as not irritating.
- Executive summary:
An acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of FeNaEDDHA on the albino rat skin. This test was based on the OECD Guideline No. 404 (Acute Dermal Irritation/ Corrosion) and was performed on 3 male rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 g of the test article was applied to the right flank of each animal and held in place for 4 hours by an adhesive tape. Because the mean values of the recordings 24 to 72 hours after application are scored 0, the test item FeNaEDDHA can be classified as no-irritant according to the GHS Regulation (EC) No. 1272/2008.
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