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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Phenyl Methyl Pyrazolone
Author:
Cosmetic Ingredient Expert Review Panel
Year:
1992
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 11, Number 4,1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An eye irritation study of Edaravone was conducted on rabbits to observe its ocular irritation index.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-1-phenyl-5-pyrazolone
EC Number:
201-891-0
EC Name:
3-methyl-1-phenyl-5-pyrazolone
Cas Number:
89-25-8
Molecular formula:
C10H10N2O
IUPAC Name:
1-Phenyl-3-methyl-5-pyrazolone
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Phenyl methyl pyrazolone (PMP)
- Molecular formula: C10H10N2O
- Molecular weight: 174.202 g/mole
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phenyl methyl pyrazolone (PMP) / (Edaravone)
- Molecular formula: C10H10N2O
- Molecular weight: 174.202 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
other: Propylene glycol
Controls:
other: The left eye (untreated eye) served as control
Amount / concentration applied:
Amount: 0.1ml
concentration applied: 0.66%
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3/sex)
Details on study design:
TEST SITE
- Area of exposure: conjunctival sac of the right eye of each rabbit.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.6
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: After 24 hours and on days 2, 3, 4, and 7.
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular lesions were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The ocular irritation index was observed to be 0.66/110 on day 1 and 0.00/110 on the remaining days.
Phenyl methyl pyrazolone (CAS No:-89-25-8) was considered to be not irritating to the six albino rabbits’ eye as the ocular irritation index was 0.00.
Executive summary:

An eye irritation study was performed in six albino (3/sex) rabbits to assess the ocular irritation index of test chemical Phenylmethyl pyrazolone(CAS No:-89-25-8).

 

The test substance was instilled into the conjunctival sac of the right eye of each rabbit at volume of 0.1 ml (0.66% solution of PMP in propylene glycol) and the left eye served as control. The eyes were not rinsed and examined for ocular lesions after 24 hours and on days 2, 3, 4, and 7 using a cap lamp and also examined with a fluorescent lamp after injection of 2% sodium fluorescein solution.

The ocular irritation index was observed to be 0.66/110 on day 1 and 0.00/110 on the remaining days. As the ocular lesions were not persisted until 7 days observation period with ocular irritation index of 0.00, the test chemical Phenyl methyl pyrazolone (CAS No:-89-25-8) was considered to be not irritating to the eyes of albino rabbits.