N-acetylsulphanilyl chloride

Endpoint summary

Description of key information

Acute Oral Toxicity:

Based on all the available data on the test chemical and also from the observations and results, it was concluded that the test chemical did not cause any mortalities, at doses above 2000 mg/kg bw and therefore is not likely to classify as a toxicant as per the CLP criteria of classification and labelling.

Acute Dermal Toxicity:

An acute dermal toxicity study does not need to be conducted since the pH of the test chemical is 1.97, which indicates the test chemical is highly acidic in nature and is likely to be classified in 'Skin irritant Category 1' as per CLP criteria of classifcation and labeling. Therfore, this endpoint is considered as a 'Waiver'.

Acute Inhalation Toxicity:

An acute inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 3.34E-007 mmHg at 25°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver.

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:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Equivalent or similar to OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No Data Available

Route of administration:

oral: gavage

Vehicle:

other: 2 % NaCS

Details on oral exposure:

No Data Available

Doses:

50-3200 mg/kg bw

No. of animals per sex per dose:

3 rats per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No Data Available
- Necropsy of survivors performed: No Data Available
- Clinical signs including body weight : Yes
- Other examinations performed: clinical signs, body weight

Statistics:

No Data Available

Preliminary study:

No Data Available

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 3 200 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed after administration of the test chemical till 3200 mg/kg bw.

Clinical signs:

Clinical signs of normal to moderate weakness and vasodilation in one animals was observed. Ataxia was also observed.

Body weight:

Normal body weight gain was observed in all the animals.

Gross pathology:

No Data Available

Other findings:

No Data Available

Interpretation of results:

other: Not Classified as per the CLP criteria of classification and labeling.

Conclusions:

Based on all the observations and results, it was concluded that the test chemical did not cause any mortalities when test chemical was administered orally to three rats at 3200 mg/kg bw. Therefore, the test chemical is not likely to classify as a toxicant as per the CLP criteria of classification and labeling.

Executive summary:

An acute oral toxicity study using the test chemical was performed using 3 animals per dose. The test chemical was administered to the rats from dose ranging from 50-3200 mg/kg bw. The test chemical was dissolved in 2% NaCS in to prepare 10% solution of the suspension. The animals were observed for 14 days, for any mortalities, clinical signs and changes in body weights. It was observed that there were no mortalities during the observation period till 3200 mg/kg bw. A few clinical signs of normal to moderate weakness and vasodilation in one animals was observed. Ataxia was also observed. Normal body weight gain was observed in all the animals. Thus, based on all the observations and results, it was concluded that the test chemical did not cause any mortalities when test chemical was administered orally to three rats at 3200 mg/kg bw. Therefore, the test chemical is not likely to classify as a toxicant as per the CLP criteria of classification and labeling.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 200 mg/kg bw

Quality of whole database:

Data is from a Klimisch 4 database but provides a robust study summary for classification and labeling of the test chemical.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The study is considered as a waiver.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The study is considered to be a waiver.

Additional information

Acute Oral Toxicity:

The available data for the test chemical for acute oral toxicity study is as follows:

Study 1:

An acute oral toxicity study using the test chemical was performed using 3 animals per dose. The test chemical was administered to the rats from dose ranging from 50-3200 mg/kg bw. The test chemical was dissolved in 2% NaCS in to prepare 10% solution of the suspension. The animals were observed for 14 days, for any mortalities, clinical signs and changes in body weights. It was observed that there were no mortalities during the observation period till 3200 mg/kg bw. A few clinical signs of normal to moderate weakness and vasodilation in one animals was observed. Ataxia was also observed. Normal body weight gain was observed in all the animals. Thus, based on all the observations and results, it was concluded that the test chemical did not cause any mortalities when test chemical was administered orally to three rats at 3200 mg/kg bw. Therefore, the test chemical is not likely to classify as a toxicant as per the CLP criteria of classification and labeling.

Study 2:

The acute oral toxicity study according to OECD test guideline 423 of the test chemical in rats showed that this chemical did not cause any significant changes in terms of LD50 at 2,000 mg/kg b.w for 1st and 2nd steps, and 5,000 mg/kg bw for limit test. Based on all the observations and results, it was concluded that the test chemical did not cause any mortalites when tested at the doses of 2000 and 5000 mg/kg bw, therefore the LD50 of the test chemical is considered to be greater than 5000 mg/kg and the test chemical was not classified as per the CLP criteria of classification and labeling.

Study 3:

An acute oral toxicity study, equivalent or similar to OECD test guideline 401, was conducted to assess the toxicity potential of the test chemical after single administration to Sprague Dawley rats. The test chemical was suspended in the corn oil to prepare a 20% suspension-solution. 5 animals per sex per dose were allocated. The doses 3980, 5010, 6310 and 7940 mg/kg bw were selected for the study. No mortality was observed at 3980 mg/kg bw while mortalities due to administration of the test chemical was observed from 5010, 6310 and 7940 mg/kg bw. Clinical signs included reduced appetite and activity (one to three days in survivors), increasing weakness, slight tremors, and death. Lung and liver hyperplasia, and acute gastrointestinal inflammation was observed in animals that died. Viscera appeared normal for all surviving animals. No changes in the body weights were observed. Therefore, based on all the observations and results, it was concluded that the LD50 value of the test chemical was greater than 2000 mg/kg bw (> 5300 mg/kg bw), as observed in the study. Thus, the test chemical is not likely to classify as a toxicant as per the CLP criteria of classification and labeling.

Acute Dermal Toxicity:

An acute dermal toxicity study does not need to be conducted since the pH of the test chemical is 1.97, which indicates the test chemical is highly acidic in nature and is likely to be classified in 'Skin irritant Category 1' as per CLP criteria of classifcation and labeling. Therfore, this endpoint is considered as a 'Waiver'.

Acute Inhalation Toxicity:

An acute inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 3.34E-007 mmHg at 25°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver.

Justification for classification or non-classification

Based on all the available data on the test chemical, it was concluded that the test chemical was not likely to cause adverse effects via oral and dermal route, while the exposure of the test chemical via inhalation route was not possible. Therefore, the test chemical is not likely to classify as a toxicant via oral, dermal and inhalation route as per the CLP criteria of classification and labeling.