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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
REPORTS of the Scientific Committee on Cosmetology (seventh series)
Author:
COMMISSION OF THE EUROPEAN COMMUNITIES;
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series), 1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of Patent Blue V in rabbits
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
EC Number:
204-934-1
EC Name:
Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
Cas Number:
129-17-9
Molecular formula:
C27H32N2O6S2.Na
IUPAC Name:
hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Patent Blue V
- Molecular formula (if other than submission substance):
C27H31N2O6S2.Na
C27H32N2O6S2.Na
- Molecular weight (if other than submission substance): 566.672 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): Patent Blue V
- Molecular formula (if other than submission substance):
C27H31N2O6S2.Na
C27H32N2O6S2.Na
- Molecular weight (if other than submission substance): 566.672 g/mole
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
other: saline
Controls:
not specified
Amount / concentration applied:
0.25 ml of saturated solution in saline
Duration of treatment / exposure:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
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:
other: no data available
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation was observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Patent Blue V was observed to be not irritating to rabbit eyes.
Executive summary:

An eye irritation study was conducted in rabbits to observe the irritation potential of the Patent Blue V.

0.25 ml of a saturated solution of Patent Blue V in saline was instilled into the eyes of rabbits and effects were observed (duration not specified).

Patent Blue V was observed to be not irritating to rabbit eyes.