Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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 journal

Data source

Reference
Reference Type:
publication
Title:
Final report of the safety assessment of niacinamide and niacin.
Author:
Cosmetic Ingredients Review (CIR)
Year:
2005
Bibliographic source:
International Journal of Toxicology 24 (Suppl 5): 1-31 2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Low volume eye test
Principles of method if other than guideline:
Low volume eye test of Niacinamide were performed in New Zealand White Rabbits to determine the degree of eye irritancy caused by the chemical.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Nicotinamide
EC Number:
202-713-4
EC Name:
Nicotinamide
Cas Number:
98-92-0
Molecular formula:
C6H6N2O
IUPAC Name:
nicotinamide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Niacinamide
- Molecular formula: C6H6N2O
- Molecular weight: 122.1264 g/mol
- Substance type: Organic
- Physical state:Solid (powder)
-Smiles: c1cc(cnc1)C(=O)N
- InChI: 1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Niacinamide
- Molecular formula: C6H6N2O
- Molecular weight: g/mol
- Substance type: Organic
- Physical state: Solid
-Smiles: c1cc(cnc1)C(=O)N
- InChI: 1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
15% and 25%
Duration of treatment / exposure:
10 days
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
No data available
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
10 d
Score:
0.67
Reversibility:
fully reversible within: 10 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No eye irritating effects were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material Niacinamide (CAS No: -98-92-0) was considered to be non-irritating to the eye of New Zealand White Rabbits in Low volume eye test.
Executive summary:

Low volume eye test of Niacinamide(CAS No: -98-92-0) was performed in New Zealand White Rabbits to determine the degree of eye irritancy caused by the chemical.

 

During the test, 16% and 25% of Niacinamide dissolved in water was placed into the eye of each rabbits.

 

The maximum average score (MAS) observed was 0.67 and the effects observed were cleared within 10 days.

 

Since the chemical did not produce any acute ocular hazards, the chemical Niacinamide(CAS No: -98-92-0)was considered to be non-irritating to the eye of New Zealand White Rabbits.