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Administrative data

Description of key information

Acute Oral Toxicity:

The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw ,when 5 male and 5 female Wistar (SPF cpB) rats were treated with Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9) orally. Thus, comparing this value with the criteria of CLPregulation,Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9)can be “Not classified” for Acute Oral Toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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:
other: as mentioned below
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9) on rats.
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report):sodium 4–chloro–3–nitrobenzenesulphonate
- Molecular formula :C6H4NNaO5S
- Molecular weight :225.1556 g/mol
- Substance type:organic
Species:
rat
Strain:
other: Wistar (SPF cpB)
Sex:
male/female
Details on test animals and environmental conditions:
Details on test animal:
TEST ANIMALS:
- Source: winkelmann, Borchen
- Age at study initiation: 14 weeks old avg.
- Weight at study initiation: Initial weight of male animals was 161 g and the female rats had an average initial weight of 160 g.
- Fasting period before study: No data available
- Housing: The rats were kept conventionally in Makrolonkaefigen type III on dust-free wood granules in groups of 5 each animals.
- Diet (e.g. ad libitum): the feed : Altromin R 1324 was given ad libitum
- Water (e.g. ad libitum): water was provided ad libitum for approximately 16 hours and before until about 4 hours after application.
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5 degrees Celsius
- Humidity (%):approx. 60 +/- 5%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 2 hours of light / dark rhythm (artificial Lighting from 7 am to 7 pm CET)

IN-LIFE DATES: From: To: 25.8.1980 to 8.9.1980
Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
Details on exposure:
VEHICLE
- Concentration in vehicle:5000mg/kg bw
- Amount of vehicle (if gavage): 20 ml/kg bw

- Justification for choice of vehicle: test substance was soluble in water

DOSAGE PREPARATION (if unusual): The substance was formulated in water using a rigid metal stomach probe in koaslantem
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total : 10 animals
5000 mg/kg bw :5 males and 5 females
Control animals:
not specified
Details on study design:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: after 1 week and at the end of the
14 days animals were weighed individually.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs
Statistics:
No data available
Preliminary study:
No data available
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed in treated rats at 5000 mg/kg bw
Mortality:
No mortality was observed in treated rats at 5000 mg/kg bw
Clinical signs:
No poisoning symptoms were observed
Body weight:
No data available
Gross pathology:
The section of some animals killed at the end of the experiment showed no macroscopic findings.
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw ,when 5 male and 5 female Wistar (SPF cpB) rats were treated with Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9) orally.
Executive summary:

Acute oral toxicity study was done in 5 male and 5 female Wistar (SPF cpB)rats using test material Sodium 4-chloro-3-nitrobenzenesulphonate(17691-19-9) following 14 days of observation period.Rats were 14 weeks old.Initial weight of male animals was 161 g and the female rats had an average initial weight of 160 g. The rats were conventionally kept in Makrolonkaefigen type III on dust-free wood granules at a room temperature of 22 +/- 1.5 degrees Celsius and 2 hours of light / dark rhythm (artificial lighting from 7 am to 7 pm CET) and a relative humidity of approx. 60 +/- 5% in groups of 5 each animals.The feed,Altromin R 1324 was given ad libitum. Water was provided ad libitum for approximately 16 hours and before until about 4 hours after application.Water was used as vehicle.The substance was formulated in water using a rigid metal stomach probe in koaslantem. Application volume (20 ml / kg body weight) to each 5

males and 5 females were given once. After 1 week and at the end of the 14 days animals were weighed individually.No mortality was observed at dose 5000 mg/kg bw.No poisoning symptoms were observed in animals.The section of some animals killed at the end of the experiment showed no macroscopic findings.Hence,LD50 value was considered to be >5000 mg/kg bw,when rats were treated withSodium 4-chloro-3-nitrobenzenesulphonate(17691-19-9) orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimicsh 2 and data is from experimental report

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Oral Toxicity:

In different studies, Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9)has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9).

In an experimental study conducted by Sustainability Support Services (Europe) AB (Institute of Toxicology,wuppertal,1982-07-29,Report no. T8014021) for the target substance Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9). Acute oral toxicity study was done in 5 male and 5 female Wistar (SPF cpB)rats using test material Sodium 4-chloro-3-nitrobenzenesulphonate(17691-19-9) following 14 days of observation period.Rats were 14 weeks old.Initial weight of male animals was 161 g and the female rats had an average initial weight of 160 g. The rats were conventionally kept in Makrolonkaefigen type III on dust-free wood granules at a room temperature of 22 +/- 1.5 degrees Celsius and 2 hours of light / dark rhythm (artificial lighting from 7 am to 7 pm CET) and a relative humidity of approx. 60 +/- 5% in groups of 5 each animals.The feed,Altromin R 1324 was given ad libitum. Water was provided ad libitum for approximately 16 hours and before until about 4 hours after application.Water was used as vehicle.The substance was formulated in water using a rigid metal stomach probe in koaslantem. Application volume (20 ml / kg body weight) to each 5 males and 5 females were given once. After 1 week and at the end of the 14 days animals were weighed individually.No mortality was observed at dose 5000 mg/kg bw.No poisoning symptoms were observed in animals.The section of some animals killed at the end of the experiment showed no macroscopic findings.Hence,LD50 value was considered to be >5000 mg/kg bw,when rats were treated with Sodium 4-chloro-3-nitrobenzenesulphonate(17691-19-9) orally.

In another experimental study conducted by European Chemicals Bureau (ECB)( IUCLID DATASET, European Chemicals Bureau (ECB), 18–FEB–2000) for the target substance Sodium 4-Chloro-3-Nitrobenzenesulphonate (17691-19-9). Acute oral toxicity study was done in rats using test material Sodium 4-Chloro-3-Nitrobenzenesulphonate (17691-19-9).No mortality was observed at dose 5000 mg/kg bw. Hence,LD50 value was considered to be >5000 mg/kg bw,when rats were treated with Sodium 4-Chloro-3-Nitrobenzenesulphonate (17691-19-9)orally.

 Also these results are further supported by the experimental study conducted by U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine,2017) and IFA GESTIS (GESTIS SUBSTANCE Database ,2017) for the structurally similar read across substance Sodium 3-nitrobenzenesulphonate (127-68-4). Acute oral toxicity study was done in rats using test material Sodium 3-nitrobenzenesulphonate(127-68-4).50% mortality was observed at dose 11000 mg/kg bw. Hence,LD50 value was considered to be 11000 mg/kg bw,when rats were treated with Sodium 3-nitrobenzenesulphonate (127-68-4)orally.

Thus, based on the above studies and predictions on Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9) and its structurally similar read across substances, it can be concluded that LD50 value was >5000 mg/kg bw.Thus,comparing this value with the criteria of CLPregulation,Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9) can be “Not classified” for Acute Oral Toxicity.

Justification for classification or non-classification

Thus, comparing this value with the criteria of CLPregulation,Sodium 4-chloro-3-nitrobenzenesulphonate(17691-19-9) can be “Not classified” for Acute Oral Toxicity.