Sodium 3-nitrobenzenesulphonate

Endpoint summary

Description of key information

Skin irritation

The dermal irritation potential of test chemical was assessed in various experimental studies conducted on rabbits. The predicted data using Danish QSAR database has also been compared with the experimental data. Based on the available data for the key and supporting studies, it can be concluded that the test chemical is unable to cause skin irritation and thus 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

An ocular irritation potential of target chemical was assessed in various experimental studies conducted on rabbits. Based on the available data for the key and supporting studies, it can be concluded that the test chemical is able to cause severe eye damage and thus can be considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

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:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Data is from experimental study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

A Draize Test was carried out for chemical Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4) to assess its skin irritation potential.

GLP compliance:

no

Specific details on test material used for the study:

Name of the test chemical: Sodium 3-nitrobenzenesulfonate
Molecular Formula:C6H5NO5S.Na
Molecular Weight: 225.1556 g/mol
Substance Type: Organic
Physical State: Solid

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Mean body weights for male animals 2.87 kg, female animals 2.97 kg

Type of coverage:

occlusive

Preparation of test site:

other: either intact or abraded

Vehicle:

water

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

Concentration: 50%

Duration of treatment / exposure:

24 hour(s)

Observation period:

8 d

Number of animals:

6

Details on study design:

After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 72 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404.

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

1.2

Max. score:

2

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: intact skin

Irritant / corrosive response data:

All skin reactions were disappeared within 8 days.

Interpretation of results:

other: not irritating

Conclusions:

From the experimental results, it is concluded that Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4)was not irritating to the skin of white Vienna rabbits.

Executive summary:

A Draize Test was carried out for chemical Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4) on skin of six white Vienna rabbits in accordance with OECD test guideline 404.

The chemical was applied to the intact or abraded skin of each rabbit at a dose of 50% of Sodium 3-nitrobenzenesulphonate in water for 24 hours under occlusive condition.

After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 72 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404.

The chemical caused slight erythema and edema which were fully reversible within 8 days.

Since the observed effects were not persisted during the observed period, the chemical Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4) was considered as not irritating to the skin of white Vienna rabbits.

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:

comparable to guideline study

Justification for type of information:

Data is from experimental report

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A Draize Test was carried out for chemical Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4) to assess the eye irritation potential of six white Vienna rabbits.

GLP compliance:

no

Specific details on test material used for the study:

Name of the test chemical: Sodium 3-nitrobenzenesulfonate
Molecular Formula:C6H5NO5S.Na
Molecular Weight: 225.1556 g/mol
Substance Type: Organic
Physical State: Solid

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Mean body weight of the rabbits: 2.7 kg for males and 2.64 kg for females

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

6

Details on study design:

The eyes were not washed out after 24 hours after substance application. Findings were graded as described in OECD test guideline 405.
Findings were recorded after 24, 48, 78 hours, and at the end of the observation period (8 days).

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

0.3

Max. score:

1

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 h

Score:

0.5

Max. score:

2

Reversibility:

fully reversible within: 8 d (exemption: reddening)

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

24 h after application of the test substance, 2/6 animals showed opacicity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 6/6 animals showed redness of the conjunctivae grade 2, 5/6 showed swelling of the conjunctivae grade 1 and 6/6 showed secretion. 48 h after application of the test substance, 2/6 animals showed opacicity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 5/6 animals showed redness of the conjunctivae grade 1-2, 4/6 showed swelling of the conjunctivae grade 1 and 4/6 showed secretion. 72 h after application of the test substance, 2/6 animals showed opacicity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 5/6 animals showed redness of the conjunctivae grade 1-2, 4/6 showed swelling of the conjunctivae grade 1 and 3/6 showed secretion.
Opacicity of the cornea (grade 1, area 1/4-1/2) persisted in 2/6 animals while conjunctival redness grade 1 persisted in 3/3 animals until the end of the observation period. Other signs of toxicity were not noted.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

From the experimental results, it is concluded that sodium 3-nitrobenzenesulphonate is regarded as irritating to the eye of white Vienna rabbits.

Executive summary:

A Draize Test was carried out for chemical Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4) to assess the eye irritation potential of six white Vienna rabbits.

About 0.1ml of test chemical was instilled into the eye of each rabbits and the eyes were not washed out after 24 hours after substance application.

 Findings were graded as described in OECD test guideline 405 and were recorded after 24, 48, 78 hours, and at the end of the observation period (8 days).

24 h after application of the test substance, 2/6 animals showed opacicity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 6/6 animals showed redness of the conjunctivae grade 2, 5/6 showed swelling of the conjunctivae grade 1 and 6/6 showed secretion. 48 h after application of the test substance, 2/6 animals showed opacity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 5/6 animals showed redness of the conjunctivae grade 1-2, 4/6 showed swelling of the conjunctivae grade 1 and 4/6 showed secretion. 72 h after application of the test substance, 2/6 animals showed opacity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 5/6 animals showed redness of the conjunctivae grade 1-2, 4/6 showed swelling of the conjunctivae grade 1 and 3/6 showed secretion. Opacity of the cornea (grade 1, area 1/4-1/2) persisted in 2/6 animals while conjunctival redness grade 1 persisted in 3/3 animals until the end of the observation period. Other signs of toxicity were not noted.

Thus from the observed findings, it is concluded that the chemical Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4) was irritating to the eyes of white Vienna rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

Various studies has been investigated for the test chemical to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical. The predicted data using the Danish QSAR database has also been compared with the experimental data and summarized as below;

 

A Draize Test was carried out for test chemical on skin of six white Vienna rabbits in accordance with OECD test guideline 404. The chemical was applied to the intact or abraded skin of each rabbit at a dose of 50% of Sodium 3-nitrobenzenesulphonate in water for 24 hours under occlusive condition. After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 72 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404. The chemical caused slight erythema and edema which were fully reversible within 8 days. Since the observed effects were not persisted during the observed period, the test chemical was considered as not irritating to the skin of white Vienna rabbits.

 

Another Skin irritation study was conducted by on Vienna White rabbits for test chemical to determine the skin effects caused by the chemical over a period of 8 days. The chemical was applied to the intact or abraded skin of each rabbit at a dose of 50% of Sodium 3-nitrobenzenesulphonate in water under occlusive condition. Skin reactions were evaluated at 5 min and 2 hours and on day 8. The chemical did not produce any sign of skin lesions. Thus rom the experimental results, it is concluded that the chemical  was considered to be not irritating to the skin of white Vienna rabbits.

 

The overall results were further supported by the predicted data estimated by Danish QSAR database. According to Danish QSAR database, the skin irritation effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no skin irritation reactions were observed in rabbits. Therefore, the test chemical was considered to be not irritating.

Based on the available data for key and supporting studies, it can be concluded that test chemical is unable 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:

In different studies, the test chemical has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical that have been summarized as below;

 

A Draize Test was carried out for test chemical to assess the eye irritation potential of six white Vienna rabbits. About 0.1ml of test chemical was instilled into the eye of each rabbits and the eyes were not washed out after 24 hours after substance application. Findings were graded as described in OECD test guideline 405 and were recorded after 24, 48, 78 hours, and at the end of the observation period (8 days). 24 h after application of the test substance, 2/6 animals showed opacicity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 6/6 animals showed redness of the conjunctivae grade 2, 5/6 showed swelling of the conjunctivae grade 1 and 6/6 showed secretion. 48 h after application of the test substance, 2/6 animals showed opacity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 5/6 animals showed redness of the conjunctivae grade 1-2, 4/6 showed swelling of the conjunctivae grade 1 and 4/6 showed secretion. 72 h after application of the test substance, 2/6 animals showed opacity of the cornea grade 1 (area 1/4-1/2), 1/6 animal showed circumcorneal injection, 5/6 animals showed redness of the conjunctivae grade 1-2, 4/6 showed swelling of the conjunctivae grade 1 and 3/6 showed secretion. Opacity of the cornea (grade 1, area 1/4-1/2) persisted in 2/6 animals while conjunctival redness grade 1 persisted in 3/3 animals until the end of the observation period. Other signs of toxicity were not noted. Thus from the observed findings, it is concluded that the chemical  was irritating to the eyes of white Vienna rabbits.

 

Another ocular irritation study of test chemical was conducted on rabbits which supported the above mentioned result. In this study, the chemical was installed at a dose of 20 mg for 24 hours into the eye of each rabbits, which produced moderate irritation. Therefore the test chemical was considered to be moderately irritating to the eye of rabbits.

 

Thus based on the available data for the target as well as supporting studies, it can be concluded that test chemical is able to cause severe eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical were observed in various studies. The results obtained from these studies indicates that the chemical is unlikely to cause skin irritation but can cause severe eye damage. Hence the test chemical can be classified under the category “Not Classified” for skin and “Category 2” for eye as per CLP.