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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- 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)
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)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Test system

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.

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
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

Any other information on results incl. tables

Table: Acute Dermal Irritation in Rabbits

(According to OECD 404 Guidelines)

Animal number

Sex

Erythema

Edema

Skin fold thickness

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

-

 

Applicant's summary and conclusion

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.