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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
Oct 1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959
Reference Type:
other company data
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Internal Guideline Hoechst
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
EC Number:
263-418-4
EC Name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
Cas Number:
62121-76-0
Molecular formula:
C20H20N4Na2O12S3
IUPAC Name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
other: Silver Yellow
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: single
- Diet (e.g. ad libitum): Standard food Altromin
- Water (e.g. ad libitum): tap water

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.25 mL of 10 % aqueous solution
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
3
Details on study design:
0.25 mL of a 10% aqueous solution of the test material was instilled in the conjunctivael sac of the rabbit eye. Evaluation of rabbit eyes 1, 3, 7, and 24 hours after application of the test solution

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation have been observed.
Other effects:
NA

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No signs of eye irritation have been observed in this study.
Executive summary:

In a primary eye irritation study, 0.25 mL of a 10 % solution of the test material was instilled into the conjunctival sac of rabbits. No further information on the study design was available. No signs of irritation were reported. Based on the available data, this study can not be used for classification according to CLP criteria and is used as supporting information only.