Registration Dossier
Registration Dossier
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EC number: 949-050-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: experimental data on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- EC Number:
- 289-068-2
- EC Name:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- Cas Number:
- 85959-73-5
- Molecular formula:
- C32H22CoN8O16S2.3Na
- IUPAC Name:
- trisodium;cobalt(3+);(2Z)-2-[(5-nitro-2-oxido-3-sulfonatophenyl)hydrazinylidene]-3-oxo-N-phenylbutanimidate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: 15-16 weeks
Body weight: 2.1 -2.7 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 4 days under test conditions after veterinary control.
Accomodation: Caged singly in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG D
Temperature of 22°C and with a humidity of 40-70%.
Animals were exposed to artificial light for 12 hours daily, Music/light period.
Diet: Pelleted standard Kliba 341, Batch 11/85 rabbit maintenance diet (Kliba, Klingentalmuehle AG, Kaiseraugst CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water from Itingen ad libitum. The water was analysed and the results are attached to the study report.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g of the test compound was applied to each test site on a 3 cm square surgical gauze pad.
This were covered with aluminium foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. - Duration of treatment / exposure:
- no data
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 2 males, 1 female
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved with an electric clipper over an area consisting of 100 square centimeters (10 cm x 10 cm)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: all animals
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- No irritation effect observed on all animals. The primary irritation index was 0 when applied to intact skin.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. - Other effects:
- Coloration: in the area of application a clear visible brownish disocloration of the test skin was observed which could be related to effects of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.
- Executive summary:
The primary irritation score was assessed following OECD 404.
The results show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under Regulation EC 1272/2008 .
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