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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-062-3 | CAS number: 40754-59-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics.
- Author:
- Johnson Jr, W., Heldreth, B., Bergfeld, W.F., Belsito, D.V., Hill, R.A., Klaassen, C.D., Liebler, D.C., Marks Jr, J.G., Shank, R.C., Slaga, T.J. and Snyder, P.W.
- Year:
- 2 016
- Bibliographic source:
- International Journal of Toxicology, 35(2_suppl), pp.41S-54S; 2016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The primary ocular irritation of Sodium formate was assessed in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium formate
- EC Number:
- 205-488-0
- EC Name:
- Sodium formate
- Cas Number:
- 141-53-7
- Molecular formula:
- CH2O2.Na
- IUPAC Name:
- Sodium formate
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: Sodium formate
Molecular Formula:CH2O2.Na
Molecular Weigth: 69.02 g/mol
InChI: 1S/CH2O2.Na/c2-1-3;/h1H,(H,2,3);/q;+1/p-1
Substance Type: Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: Sodium formate
Molecular Formula:CH2O2.Na
Molecular Weigth: 69.02 g/mol
InChI: 1S/CH2O2.Na/c2-1-3;/h1H,(H,2,3);/q;+1/p-1
Substance Type: Organic
Physical State: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: at least 8 weeks old
- Sex: Male and female
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml, powder
- Duration of treatment / exposure:
- no data available
- Observation period (in vivo):
- Reactions were scored at 1,24,48 and 72 hours, and 7,10,14 and 17 days post-instillation
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6 rabbits (3 male and 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: lower conjunctival sac of left eye
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 17 days
- Score:
- 0
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Moderate to severe conjunctival irritation was observed in all rabbits and conjunctival necrosis was observed in 4 of 6 rabbits. All reactions had cleared by 17 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Moderate to severe conjunctival irritation was observed in all rabbits and conjunctival necrosis was observed in 4 of 6 rabbits. All reactions had cleared by 17 days.
Since the effects are fully reversible in 17 days, hence Sodium formate can be considered to be not irritating to eyes. - Executive summary:
The ocular irritation potential of Sodium formate was assessed in 6 New Zealand White rabbits (3 males, 3 females).
Sodium formate (0.1 ml, powder) was instilled in the lower conjunctival sac of the left eye of the rabbits. The right eye remained untreated and served as control.Reactions were scored at 1, 24, 48 and 72 hours, and 7,10,14 and 17 days post-instillation.
Moderate to severe conjunctival irritation was observed in all rabbits and conjunctival necrosis was observed in 4 of 6 rabbits. All reactions had cleared by 17 days.
Since the effects are fully reversible in 17 days, hence Sodium formate can be considered to be not irritating to eyes.
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.
