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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Skin Irritation: Not irritating (OECD 404, rabbit)
Eye Irritation: Not irritating (OECD 405, rabbit)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was carried out in compliance with GLP according to Guideline 84/449/EWG, B.4 and OECD 404. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.4, OECD 404 (1981)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: polyethylene glycol 400
Controls:
not specified
Amount / concentration applied:
moistened with polyethylene glycol 400 in a ratio of 500 mg of substance plus 0.9 ml of PEG 400.
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Time point:
other: No data
Score:
1
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.4 and OECD 404. The substance is non-irritating to skin.
Executive summary:

The substance was applied to the intact rabbit skin for 4 hours. The animals exhibited a hardly perceptible erythema 30 -60 minutes after the removal of patch. No signs of irritation at all were observed as from the 1st day p.a. During the entire test period only yellow discolouration of the skin occurred.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
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
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Observation period (in vivo):
24, 48 an 72 h
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.

Application form: conjunctival sack of eye

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

In a study comparable to OECD Guideline 404 with acceptable deviations (three test site per animal, clinical signs not reported and no details of test material) three albino rabbits were exposed for 4 hour period of time under semi occlusive dressing to a patch of 1 inch x 1 inch. Substance was applied to the intact, shorn skin in the dorsal region of the rump (surface area 25 cm2). The animals exhibited a hardly perceptible erythema 30 -60 minutes after the removal of patch. No signs of irritation at all were observed as from the 1st day p.a. During the entire test period only yellow discolouration of the skin occurred. The substance was precipitated on the skin so the erythema score was given as 1. Based on the results of this study, the test material Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate is non-irritant to the skin of rabbit under test conditions. The study was conducted in compliance with GLP.

This study is classified as acceptable and satisfies the guideline requirements for the skin irritation/corrosion study. The result of this study is used as a key value for hazard assessment and classification and labeling.

Eye irritation

In a study comparable to OECD Guideline 405 with acceptable deviations (three test site per animal, clinical signs not reported and no details of test material) three albino rabbits were exposed to the substance. 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. At 24 hours the conjunctival vessels of two animals were still clearly injected. At 72 hours no irritation of the eyes were observed. Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate is non-irritant to the eye of rabbit under test conditions. The study was conducted in compliance with GLP.

This study is classified as acceptable and satisfies the guideline requirements for the eye irritation study. The result of this study is used as a key value for hazard assessment and classification and labeling.


Justification for selection of skin irritation / corrosion endpoint:
The guideline compliant study.

Justification for selection of eye irritation endpoint:
The guideline compliant study.

Justification for classification or non-classification

Based on this data there is currently no need for classification of this substance for skin and eye irritation according to the CLP Regulation (EC) 1272/2008 and EU Directive 67/548/EEC.