Registration Dossier

Skin Irritation:

Negative effects were observed in all the rabbits after 72 hours of observation. The mean irritation score was 0.0 after 72 hours. Hence, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to skin.

Eye Irritation:

No special observations were observed in rabbits after 7 days. The mean irritation score for cornea, conjunctivae (redness and swelling) and iris after 7 days were 0,0,0 respectively.

Based on the scores and observations, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to rabbit eyes.

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

data is from experimental reports

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to determine the cutaneous toxicity of Sodium 4-chloro-3-nitrobenzenesulphonate

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of the test material: Sodium 4-chloro-3-nitrobenzenesulphonate
- IUPAC Name : sodium 4-chloro-3-nitrobenzene-1-sulfonate
- Molecular formula: C6H4ClNO5SNa
- Molecular weight: 259.601 g/mol
- Smiles: S(=O)(=O)([O-])c1cc([N+]([O-])=O)c(Cl)cc1.[Na+]
- InChI: 1S/C6H4ClNO5S.Na/c7-5-2-1-4(14(11,12)13)3-6(5)8(9)10;/h1-3H,(H,11,12,13);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid powder (Off white to pale yellow)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: Male and female
- Source: Hacking and Churchill Limited, Huntingdon, England
- Age at study initiation: no data available
- Weight at study initiation:
- Housing:individually in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K Pallets, ad libitum (Ssniff Experimental animal diet GmbH, 4770 Soest)
- Water (e.g. ad libitum): Drinking water ad libitum from plastic bottles with steel nipples
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deg C
- Humidity (%): 60%
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light):12-hour light-dark rhythm

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

500 mg of the substance were dissolved with 0.1 ml of double-distilled water

Duration of treatment / exposure:

4 hours

Observation period:

(1h), 24, 48, 72 hours and, if necessary, 7 days after treatment for erythema on the cutaneous

Number of animals:

3 (1 male and 2 female)

Details on study design:

TEST SITE
- Area of exposure: dorsal and lateral parts of the trunk
- % coverage: 2.5 × 2.5 cm gauze swab Transfilmine. Combined Fixiarl
- Type of wrap if used: Transfilmine. Combined Fixiarl

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: After the end of the exposure time, the bare skin areas were rinsed with water and soap and dried.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : The observation period lasted 72 hours or 7 days;
Each animal was observed at 1h, 24, 48, 72 hours and, if necessary, 7 days after treatment for erythema and edema

SCORING SYSTEM:
- Method of calculation: Skin lesions were scored according to the following OECD Guidelines on testing materials where appropriate responses were recorded.

Other effects / acceptance of results:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All rabbits in which the test substance was applied to the skin, negative effects were observed

Table: Acute Dermal Irritation in Rabbits

(According to OECD 404 Guidelines)

Animal number	Sex	Erythema					Edema					Skin fold thickness
Animal number	Sex	1h	24h	48h	72h	7 days	1h	24h	48h	72h	7 days
135	Male	0	0	0	0	-	0	0	0	0	-	Not measured
194	Female	0	0	0	0	-	0	0	0	0	-	Not measured
195	Female	0	0	0	0	-	0	0	0	0	-	Not measured
Mean		0	0	0	0	-	0	0	0	0	-

Interpretation of results:

other: Not irritating

Conclusions:

Negative effects were observed in all the rabbits after 72 hours of observation. The mean irritation score was 0.0 after 72 hours. Hence, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to skin.

Executive summary:

The objective of the study was to determine the cutaneous toxicity of Sodium 4-chloro-3-nitrobenzenesulphonate. The study was performed as per OECD 404 Guidelines. 3(1 male and 2 female) New Zealand White rabbits were used. For the determination of the acute irritative effect, the dorsal and lateral parts of the trunk were shaved 16-24 hours prior to treatment with an electric cutting machine. The test substance was administered as an 83% aqueous solution. In addition, 500 mg of the substance were dissolved with 0.1 ml of double-distilled water. The aqueous solution was spread on a flax of about 6 cm 2 on the gastric dorsal skin, covered with a 2.5 × 2.5 cm gauze swab Transfilmine Combined Fixiarl for four hours.During the exposure time, the rabbits were housed individually in separate cages. After the end of the exposure time, the bare skin areas were rinsed with water and soap and dried. The observation period lasted 72 hours or 7 days. Each animal was observed at 1h, 24, 48, 72 hours and, if necessary, 7 days after treatment for erythema and edema. Skin lesions were scored according to the following OECD Guidelines on testing materials where appropriate responses were recorded.

Negative effects were observed in all the rabbits after 72 hours of observation. The mean irritation score was 0.0 after 72 hours. Hence, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to skin.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

data is from experimental reports

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to determine the ocular toxicity of Sodium 4-chloro-3-nitrobenzenesulphonate

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of the test material: Sodium 4-chloro-3-nitrobenzenesulphonate
- IUPAC Name : sodium 4-chloro-3-nitrobenzene-1-sulfonate
- Molecular formula: C6H4ClNO5SNa
- Molecular weight: 259.601 g/mol
- Smiles: S(=O)(=O)([O-])c1cc([N+]([O-])=O)c(Cl)cc1.[Na+]
- InChI: 1S/C6H4ClNO5S.Na/c7-5-2-1-4(14(11,12)13)3-6(5)8(9)10;/h1-3H,(H,11,12,13);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid powder (Off white to pale yellow)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Sex: Male and female
- Source: Hacking and Churchill Limited, Huntingdon, England
- Age at study initiation: no data available
- Weight at study initiation:
- Housing:individually in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K Pallets, ad libitum (Ssniff Experimental animal diet GmbH, 4770 Soest)
- Water (e.g. ad libitum): Drinking water ad libitum from plastic bottles with steel nipples
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deg C
- Humidity (%): 60%
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light):12-hour light-dark rhythm

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100mg/rabbit

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

The observation period lasted 72 hours or 7 days. Each animal was observed at 1h, 24, 48, 72 hours and, if necessary, 7 days after treatment fro ocualr lesions

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3 (1 male, 2 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

SCORING SYSTEM: The ocular lesions were scored according to the following OECD Guidelines where appropriate responses were recorded

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: For the eye examination a hand slit lamp was used.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

redness and swelling

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

7 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No special observations were done.

Table: Acute Ocular Irritation in Rabbits

(According to OECD 405 Guidelines)

Rabbit number	Sex	Cornea					Iris					Conjunctiva (R/S)*					Total
Rabbit number	Sex	1h	24h	48h	72h	7 days	1h	24h	48h	72h	7 days	1h	24h	48h	72h	7 days	1h	24h	48h	72h	7 days
135	M		0	0	0	0		0	0	0	0		0/0	1/0	0/0	0/0		0	1	0	0
166	F	0	0	0	0	0	0	0	0	0	0	0/0	1/0	1/0	1/0	0/0	0	1	1	1	0
176	F		0	0	0	0		0	0	0	0		0/0	1/0	1/0	0/0		0	0	0	0
Mean		0	0	0	0	0		0	0	0	0		0/0	1/0	1/0	0/0		0	1	1	0

Interpretation of results:

other: not irritating

Conclusions:

No special observations were observed in rabbits after 7 days. The mean irritation score for cornea, conjunctivae (redness and swelling) and iris after 7 days were 0,0,0 respectively.
Based on the scores and observations, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to rabbit eyes.

Executive summary:

The objective of the study was to determine the ocular toxicity of Sodium 4-chloro-3-nitrobenzenesulphonate. The study was performed as per OECD 405 Guidelines. 3 New Zealand White rabbits(2 female and 1 male) were used for the study. 100 mg of the test material / rabbit was placed in the eyelid pocket of one eye created by peeling off the lower eyelid. The second eye remained untreated and served as a control. For the eye examination a hand slit lamp was used.The observation period lasted 72 hours or 7 days. The observation period lasted 72 hours or 7 days. Each animal was observed at 1h, 24, 48, 72 hours and, if necessary, 7 days after treatment for ocular lesions.

The ocular lesions were scored according to the following OECD Guidelines where appropriate responses were recorded.

No special observations were observed in rabbits after 7 days. The mean irritation score for cornea, conjunctivae (redness and swelling) and iris after 7 days were 0,0,0 respectively.

Based on the scores and observations, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to rabbit eyes.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Skin Irritation:

The objective of the study was to determine (Sustainability Support Services (Europe) AB has letter of access) the cutaneous toxicity of Sodium 4-chloro-3-nitrobenzenesulphonate. The study was performed as per OECD 404 Guidelines. 3(1 male and 2 female) New Zealand White rabbits were used. For the determination of the acute irritative effect, the dorsal and lateral parts of the trunk were shaved 16-24 hours prior to treatment with an electric cutting machine. The test substance was administered as an 83% aqueous solution. In addition, 500 mg of the substance were dissolved with 0.1 ml of double-distilled water. The aqueous solution was spread on a flax of about 6 cm 2 on the gastric dorsal skin, covered with a 2.5 × 2.5 cm gauze swab Transfilmine Combined Fixiarl for four hours.During the exposure time, the rabbits were housed individually in separate cages. After the end of the exposure time, the bare skin areas were rinsed with water and soap and dried. The observation period lasted 72 hours or 7 days. Each animal was observed at 1h, 24, 48, 72 hours and, if necessary, 7 days after treatment for erythema and edema. Skin lesions were scored according to the following OECD Guidelines on testing materials where appropriate responses were recorded.

Negative effects were observed in all the rabbits after 72 hours of observation. The mean irritation score was 0.0 after 72 hours. Hence, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to skin.

Eye Irritation:

The objective of the study was to determine (Sustainability Support Services (Europe) AB has letter of access) the ocular toxicity of Sodium 4-chloro-3-nitrobenzenesulphonate. The study was performed as per OECD 405 Guidelines. 3 New Zealand White rabbits (2 female and 1 male) were used for the study. 100 mg of the test material / rabbit was placed in the eyelid pocket of one eye created by peeling off the lower eyelid. The second eye remained untreated and served as a control. For the eye examination a hand slit lamp was used. The observation period lasted 72 hours or 7 days. Each animal was observed at 1h, 24, 48, 72 hours and, if necessary, 7 days after treatment for ocular lesions.

The ocular lesions were scored according to the following OECD Guidelines where appropriate responses were recorded.

No special observations were observed in rabbits after 7 days. The mean irritation score for cornea, conjunctivae (redness and swelling) and iris after 7 days were 0, 0, 0 respectively.

Based on the scores and observations, Sodium 4-chloro-3-nitrobenzenesulphonate can be considered to be not irritating to rabbit eyes.

Available data for Sodium 4-chloro-3-nitrobenzenesulphonate indicates a strong possibility of it being not irritating to eyes and skin.

Hence, Sodium 4-chloro-3-nitrobenzenesulphonate can be classified under the category “Not Classified” as per CLP regulation.