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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 439-590-3
- EC Name:
- -
- Cas Number:
- 12158-75-7
- Molecular formula:
- Hill: Cu2(OH)3NO3 CAS:
- IUPAC Name:
- copper trihydroxynitrate
Constituent 1
- Radiolabelling:
- no
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 8 h
- Dose:
- 54.7 mg/g
- Parameter:
- other: Total Absorbed Dose
- Absorption:
- 0.38 %
- Remarks on result:
- other: -
- Remarks:
- The skin was exposed to the test preparations for 8 h, after which time the exposure period was terminated by washing. This was followed by a 16 h post exposure monitoring period
- Key result
- Time point:
- 8 h
- Dose:
- 512 mg/g
- Parameter:
- other: Total Absorbed Dose
- Absorption:
- 0.03 %
- Remarks on result:
- other: -
- Remarks:
- The skin was exposed to the test preparations for 8 h, after which time the exposure period was terminated by washing. This was followed by a 16 h post exposure monitoring period
Applicant's summary and conclusion
- Conclusions:
- In conclusion, following topical application of Basic Copper Nitrate in 1% HPMC solution
(50 mg/g, Test Preparation 2) to human skin in vitro, the absorbed dose, dermal delivery and
potentially absorbable dose were 0.38% (2.03 μg /cm2), 0.73% (3.92 μg /cm2) and 0.90%
(4.82 μg /cm2) of the applied dose, respectively. Following topical application of Basic
Copper Nitrate in 1% HPMC solution (500 mg/g, Test Preparation 3) to human skin in vitro,
the absorbed dose, dermal delivery and potentially absorbable dose were 0.03%
(2.03 μg /cm2), 0.14% (10.5 μg /cm2) and 0.18% (14.1 μg /cm2) of the applied dose,
respectively. The mass balance for Basic Copper Nitrate in Test Preparation 2 and Test
Preparation 3 was 86.73% and 92.32% of the applied dose, respectively.
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.
