Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 251-964-6 | CAS number: 34364-26-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- No details about the animals housing conditions were stated and the age and sex of the animals were not specified. No rationale for in vivo testing was included and sequential testing was not performed. Additionally, the test material was unsufficiently described.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015-07-28
- GLP compliance:
- yes
- Remarks:
- no certificate included
Test material
- Reference substance name:
- Bismuth(3+) neodecanoate
- EC Number:
- 251-964-6
- EC Name:
- Bismuth(3+) neodecanoate
- Cas Number:
- 34364-26-6
- Molecular formula:
- C10H19O2.xBi
- IUPAC Name:
- tris[(3,3,5,5-tetramethylhexanoyl)oxy]bismuthine
- Details on test material:
- - Density: 1.13- 1.14 mg/ml
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: New York State Rabbit Development, Hartwick, NY
- Weight at study initiation: 2.36-2.89 kg
- Housing: the animals were individually housed in wire mesh bottom cages in an environment- controlled room
- Diet (e.g. ad libitum): NIH Animal Feed A (certified)
- Water (e.g. ad libitum): yes
- Acclimation period: for a minimum of 5 days
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1.5, 24, 48 and 72 hours post dose
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE
- Type of wrap if used: test site was occluded with a one-inch square gauze patch held in place with Blenderm tape
REMOVAL OF TEST SUBSTANCE
- Washing: the exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1.5, 24, 48 and 72 post-dose
SCORING SYSTEM:
- Method of calculation: Draize skin reaction code
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- left
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- right
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- left
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- right
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- left
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- right
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- left
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- right
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- left
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- right
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- left
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- right
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the regulation EC No. 1272/2008 Bismuth neodecanoate (Cos Cat 83) does not need to be classified as irritating to the skin.
- Executive summary:
Bismuth neodecanoate was evaluated for its dermal irritation properties in a skin irritation test in rabbits. The back of each of the six rabbits was clipped free of fur on the day prior to dosing. On the day of dosing, a volume of 0.5 mL of bismuth neodecanoate was applied to each test site (left and right of each animal), which was occluded with a one-inch square gauze patch. Four hours post-dose, the patches and remaining material were removed. 4.5, 28, 52 and 76 after dosing the test sites were examined and scored separately for both erythema and edema according to the Draize scale. Very slight erythema and edema were observed in three of six animals. The mean of the grading at 24, 48 and 72 hours after dosing were below the classification criteria given in the regulation EC 1272/2008. Thus, no classification for skin irritation or corrosion is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
