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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in compliance with GLP standards according to Guideline 84/449/EWG, B.5 and OECD 405 (1987). However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.5
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
EC Number:
403-530-4
EC Name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
Cas Number:
129423-54-7
Molecular formula:
C17H13CaClN4O7S2
IUPAC Name:
calcium 4-chloro-5-methyl-2-{2-[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazen-1-yl}benzene-1-sulfonate
Details on test material:
Nature of Substance: Undiluted

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Observation period (in vivo):
24, 48 an 72 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 ad 72 h
Score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall 24, 48 and 72 h
Score:
0 - 2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall 24, 48 and 72 h
Score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Maximum duration: 48 h; maximum value at the end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score )
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
2
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Maximum duration: 24 h; Maximum value at the end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Maximum duration: 0 h; Maximum value at the end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Maximum duration: 0 h; Maximum value at the end of observation period: 0 (related to all animals)
Other effects:
One hour after application the conjunctiva exhibited clearly injected blood vessels up to diffusely crimson -coloured redness and swelling with the eyelids turned outwards. The iris was reddened. In addition, a yellow discharge was observed. 24 hours p.a. the conjunctival vessels of two animals were still clearly injected.

Any other information on results incl. tables

Application form: conjunctival sack of eye

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The study was carried out in compliance with GLP according to guideline 84/449/EWG, B.5 and OECD 405 (1987). The substance is non-irritating to eye.
Executive summary:

The test substance was applied in the conjunctival sac of the rabbit eye. The substance caused mild conjunctival irritation at day 1 and 2 which was fully reversible in three days.