Registration Dossier

Skin irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

The skin irritation study of read across chemical was conducted by authoritative database on guinea pigs to assess its skin irritation potential. About 1% aqueous solution of the test chemical in 1% methylcellulose was applied on the skin of guinea pigs 3 times on day 1, and 3 times on day 2. The guinea pigs were evaluated daily for dermal reactions. No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.

The above result was further supported by another dermal irritation study reported by same authoritative database for another read across chemical in rabbits. During the test, the chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration of exposure and observation period). Since the chemical did not produce any sign of skin irritation, the chemical was considered to be not irritating to rabbit skin.

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

The eye irritation study of read across chemical was conducted by authoritative database on guinea pigs to assess its eye irritation potential. About 0.1ml of 0.1% test chemical in a Cremophor EL/water mixture was instilled into the eyes of each rabbit. No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.

The above result was further supported by another ocular irritation study reported by same authoritative database for another read across chemical in rabbit to determine the degree of eye irritation caused by the chemical. About 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects till 7 days. Slight irritation effects were observed which were fully recovered within 7 days. As the observed effects were not persisted, the test material was considered to be not irritating to rabbit eye.

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on 2 skin irritation studies as- WoE-2 and WoE-3.
Skin irritation study of test chemical was conducted on rabbits and guinea pigs to assess its skin irritating effects.

GLP compliance:

not specified

Specific details on test material used for the study:

Name: Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-)
Molecular Formula: C34H28Cl2CoN10O8-S2.H
Molecular Weight: 899.6361 g/mole
InChI:1S/C17H16ClN5O4S.C17H15ClN5O4S.Co/c2*1-10-16(17(25)23(22-10)12-5-3-4-11(18)8-12)21-20-14-9-13(6-7-15(14)24)28(26,27)19-2;/h3-9,19,24-25H,1-2H3;3-9,16H,1-2H3,(H,21,24);/q;-1;+3/p-2/b21-20+;;

Species:

other: 1. Guinea pig 2.Rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: 1.Water and methylcellulose 2.not specified

Controls:

not specified

Amount / concentration applied:

1.1% in aqueous solution
2.not specified

Duration of treatment / exposure:

1.2 days
2.not specified

Observation period:

not specified

Number of animals:

not specified

Details on study design:

not specified

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not specified

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1.No skin irritation reaction were observed in treated guinea pigs .
2.No skin irritation reaction were observed in treated rabbits.

Interpretation of results:

other: not irritating

Conclusions:

The test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) was considered to be not irritating to the skin of rabbits and guinea pigs.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

The skin irritation study of read across chemical was conducted by authoritative database on guinea pigs to assess its skin irritation potential. About 1% aqueous solution of the test chemical in 1% methylcellulose was applied on the skin of guinea pigs 3 times on day 1, and 3 times on day 2. The guinea pigs were evaluated daily for dermal reactions. No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.

The above result was further supported by another dermal irritation study reported by same authoritative database for another read across chemical in rabbits. During the test, the chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration of exposure and observation period). Since the chemical did not produce any sign of skin irritation, the chemical was considered to be not irritating to rabbit skin.

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on 2 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation study of test chemical was conducted on guinea pigs and rabbits to assess its eye irritating effects.

GLP compliance:

not specified

Specific details on test material used for the study:

Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7)
Name: Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-)
Molecular Formula: C34H28Cl2CoN10O8-S2.H
Molecular Weight: 899.6361 g/mole
InChI:1S/C17H16ClN5O4S.C17H15ClN5O4S.Co/c2*1-10-16(17(25)23(22-10)12-5-3-4-11(18)8-12)21-20-14-9-13(6-7-15(14)24)28(26,27)19-2;/h3-9,19,24-25H,1-2H3;3-9,16H,1-2H3,(H,21,24);/q;-1;+3/p-2/b21-20+;;

Species:

other: 1. Guinea pig 2. rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not specified

Vehicle:

other: 1.Cremophor EL water mixture 2.Not specified

Controls:

not specified

Amount / concentration applied:

1.0.1ml of 0.1%
2. 100 mg

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

Not specified

Number of animals or in vitro replicates:

Not specified

Details on study design:

Not specified

Irritation parameter:

overall irritation score

Basis:

mean

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No eye irritation was observed in treated guinea pigs and rabbits.

Interpretation of results:

other: Not irrtating

Conclusions:

The test material Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) was considered to be irritating to the eyes of guinea pigs and rabbits.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

The eye irritation study of read across chemical was conducted by authoritative database on guinea pigs to assess its eye irritation potential. About 0.1ml of 0.1% test chemical in a Cremophor EL/water mixture was instilled into the eyes of each rabbit. No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.

The above result was further supported by another ocular irritation study reported by same authoritative database for another read across chemical in rabbit to determine the degree of eye irritation caused by the chemical. About 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects till 7 days. Slight irritation effects were observed which were fully recovered within 7 days. As the observed effects were not persisted, the test material was considered to be not irritating to rabbit eye.

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Skin irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

The skin irritation study of read across chemical was conducted by authoritative database on guinea pigs to assess its skin irritation potential. About 1% aqueous solution of the test chemical in 1% methylcellulose was applied on the skin of guinea pigs 3 times on day 1, and 3 times on day 2. The guinea pigs were evaluated daily for dermal reactions. No dermal reactions were observed even after repeated daily exposures to the test chemical. Hence, the test chemical can be considered to be not irritating to guinea pig skin.

The above result was further supported by another dermal irritation study reported by same authoritative database for another read across chemical in rabbits. During the test, the chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration of exposure and observation period). Since the chemical did not produce any sign of skin irritation, the chemical was considered to be not irritating to rabbit skin.

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7). The studies are as mentioned below:

The eye irritation study of read across chemical was conducted by authoritative database on guinea pigs to assess its eye irritation potential. About 0.1ml of 0.1% test chemical in a Cremophor EL/water mixture was instilled into the eyes of each rabbit. No positive ocular irritation reactions were observed. Hence, the test chemical was considered to be not eye irritant to the rabbits’ eye.

The above result was further supported by another ocular irritation study reported by same authoritative database for another read across chemical in rabbit to determine the degree of eye irritation caused by the chemical. About 100 mg undiluted test chemical was instilled into the eyes of rabbits and observed for effects till 7 days. Slight irritation effects were observed which were fully recovered within 7 days. As the observed effects were not persisted, the test material was considered to be not irritating to rabbit eye.

Based on the above summarized studies for target chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

The skin and eye irritation potential of test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical is unlikely to cause skin and eye irritation. Hence Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)] cobaltate(1-) (CAS No: 85959-75-7) can be classified under the category “Not Classified” for skin and eye as per CLP.