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Toxicological information

Eye irritation

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Administrative data

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

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 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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
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 / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

Table: Acute Ocular Irritation in Rabbits

(According to OECD 405 Guidelines)

Rabbit number

Sex

Cornea

Iris

Conjunctiva (R/S)*

Total

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

Applicant's summary and conclusion

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.