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Endpoint summary

Description of key information

The acute median lethal oral dose (LD50) to rats of Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine was demonstrated to be greater than 2000 mg/kg body weight.

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

Study period:

27 October 2020 - 25 February 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

30 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

Adopted 17 December 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau

Version / remarks:

November 24, 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

RccHan™:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Females nulliparous and non-pregnant: yes
Age at study initiation: approximately eight to twelve weeks of age prior to dosing (Day 1)
Weight at study initiation: 155 to 171 g
Fasting period before study: overnight prior to and approximately four hours after dosing
Housing: Animals were housed inside a limited access rodent. The facility was designed and operated to minimize the entry of external biological and chemical agents and to minimize the transference of such agents between rooms. The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food hoppers, water bottles and bedding were changed at appropriate intervals.
Diet: The animals were allowed free access to a standard rodent diet , except for overnight prior to and approximately four hours after dosing. This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
Water: Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes
Acclimation period: The animals were allowed to acclimatize for at least five days before treatment

ENVIRONMENTAL CONDITIONS
Temperature: The temperature was set to maintain the range of 20 to 24°C
Humidity: The relative humidity was set to maintain the range of 40 to 70%
Air changes: The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated. Periodic checks were made on the number of air changes in the animal rooms. Temperature and humidity were monitored daily.
Photoperiod: Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours

IN-LIFE DATES:
Experimental start date (initial animal arrival): 29 October 2020
Initial day of treatment: 03 November 2020 (day 1)
Final day of observations: 17 November 2020 (day 15)
Experimental completion date (final macroscopic examination): 24 November 2020

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
Concentration in vehicle: 200 mg/mL
Amount of vehicle: 10 mL/kg body weight
Justification for choice of vehicle: Not reported
Lot/batch no.: Not reported
Purity: Not reported

DOSAGE PREPARATION
The test item formulations were prepared on the day of dosing. The absorption of the test item was not determined.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 (female) animals at 2000 mg/kg

Control animals:

no

Details on study design:

Using available information on the toxicity of the test item, 2000 mg/kg was chosen as the starting dose.
One single animal was treated as follows:
Dose level (mg/kg): 2000
Concentration (mg/mL): 200
Dose volume (mL/kg): 10
Number of rats: 1 (female)

In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of
animals was treated as follows:
Dose level (mg/kg): 2000
Concentration (mg/mL): 200
Dose volume (mL/kg): 10
Number of rats: 1 (female)

Duration of observation period following administration: 14 days
Frequency of clinical observations: twice daily
Frequency of and weighing: weekly - the weight of each rat was recorded on Days -1 (not reported), 1 (prior to dosing), 8 and 15. Individual weekly body weight changes and group mean body weights were calculated.
Necropsy of survivors performed: yes
Method of Kill: All animals were humanely killed on Day 15 by carbon dioxide asphyxiation.

Other examinations performed:
All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of the brain, cecum, duodenum, heart, kidneys, small and large intestine, liver, lungs and bronchi, spleen, stomach, subcutaneous tissue and urinary bladder was recorded.

Statistics:

Evaluation of data included identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. If possible, the signs of evident toxicity were described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on body weight and abnormalities noted at necropsy were also identified.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

other: There were no clinical signs of reaction to treatment throughout the study.

Body weight:

other body weight observations

Remarks:

All animals were considered to have achieved satisfactory body weight gains throughout the study.

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15. (Full results in Appendix 3, appended to 'attached background material')

Interpretation of results:

other: Not classified according to EU criteria

Conclusions:

The acute median lethal oral dose (LD50) to rats of Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine was demonstrated to be greater than 2000 mg/kg body weight.

Executive summary:

The study was performed to assess the acute oral toxicity of Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine (a UVCB substance), to the rat. The study was conducted under GLP conditions and in accordance with EC method B.1, OECD 420, EPA OPPTS 870.1100, Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau.

 

Fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, at the following dose levels:

Sighting investigations: 2000 mg/kg body weight

Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight.

During the study, clinical condition, body weight and macropathology investigations were undertaken.

 

Results

There were no deaths during the study.

There were no clinical signs of reaction to treatment throughout the study.

All animals were considered to have achieved satisfactory body weight gains throughout the study.

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

 

Conclusion

The acute median lethal oral dose (LD₅₀) to rats of Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine was demonstrated to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

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

The study was performed to assess the acute oral toxicity of Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine (a UVCB substance), to the rat. The study was conducted under GLP conditions and in accordance with EC method B.1, OECD 420, EPA OPPTS 870.1100, Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau.

 

Fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, at the following dose levels:

Sighting investigations: 2000 mg/kg body weight

Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight.

During the study, clinical condition, body weight and macropathology investigations were undertaken.

 

Results

There were no deaths during the study.

There were no clinical signs of reaction to treatment throughout the study.

All animals were considered to have achieved satisfactory body weight gains throughout the study.

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

 

Conclusion

The acute median lethal oral dose (LD₅₀) to rats of Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine was demonstrated to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute oral toxicity.