Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., ammonium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 April 2017 - 18 January 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-sec-decyl, ammonium salts

Molecular formula:

C16H29NO3S

IUPAC Name:

Benzenesulfonic acid, 4-sec-decyl, ammonium salts

Constituent 2

Reference substance name:

Benzenesulfonic acid, 4-sec-undecyl, ammonium salts

Molecular formula:

C17H31NO3S

IUPAC Name:

Benzenesulfonic acid, 4-sec-undecyl, ammonium salts

Constituent 3

Reference substance name:

Benzenesulfonic acid, 4-sec-dodecyl, ammonium salts

Molecular formula:

C18H33NO3S

IUPAC Name:

Benzenesulfonic acid, 4-sec-dodecyl, ammonium salts

Constituent 4

Reference substance name:

Benzenesulfonic acid, 4-sec-tridecyl, ammonium salts

Molecular formula:

C19H35NO3S

IUPAC Name:

Benzenesulfonic acid, 4-sec-tridecyl, ammonium salts

Test material form:

other: Highly viscous light yellow liquid

Details on test material:

Storage Conditions: Highly viscous light yellow liquid

Specific details on test material used for the study:

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:

Test animals

Species:

rat

Strain:

other: Crl:WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Margate, UK
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: All within ±20 % of the mean value
- Fasting period before study: Yes, on the evening prior to dosing.
- Housing: The animals were housed in groups of up to five during the acclimatisation period in cages that conform to the 'Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’ (Home Office, London, 2014). From the day prior to dosing (Day-1), the rats were housed in groups of three in similar cages. Bedding was provided on a weekly basis to each cage by use of clean European soft wood bedding (Datesand Ltd., Manchester, UK). Each batch of bedding was analysed for specific constituents and contaminants. No contaminants were present in bedding at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Diet (e.g. ad libitum): Throughout the study the animals had access to 5LF2 EU Rodent Diet 14%, which was freely available to the animals at all times, except for a period of fasting from the evening of the day prior to dosing (Day-1) until approximately 3 hours after dosing. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer. No contaminants were present in diet at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Water (e.g. ad libitum): Mains water was provided ad libitum via cage mounted water bottles. The water was periodically analysed for specific contaminants. No contaminants were present in water at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Acclimation period: 7 to 10 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 ºC
- Humidity (%): 45-65 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: 25 April 2017 To: 01 June 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30, 103 and 200 mg/mL for the 300. 1031 and 2000 mg/kg bw groups, respectively.
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: n/a
- Lot/batch no. (if required): n/a
- Purity: n/a

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw (applied from a 200 mg/mL formulation).

DOSAGE PREPARATION (if unusual): The test article was dispersed in purified water. The formulated concentrations were calculated from the selected dose level and the dose volume of 10 mL/kg. All formulations were used within two hours of preparation.
The formulations were either maintained on a magnetic stirrer or the dose containers repeatedly inverted prior to administration, to ensure homogeneity.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Maximum concentration as stipulated in OECD 423.

Doses:

2000, 1031 and 300 mg/kg bw

No. of animals per sex per dose:

6 animals receievd the 300 mg/kg bw dose, groups of 3 animals each received 1031 and 2000 mg/kg bw. Dosing of the group at 1031 mg/kg bw was conducted in error, but does not impact the validity of the study.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual records of clinical signs and times of death were maintained for each treated rat. Individual body weights were recorded on Day-1 (day before dosing) and on Days 1, 4, 8 and 15. Decedent carcass weights were also recorded prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Three animals treated at 2000 mg/kg and one animal treated at 1031 mg/kg were found dead one day after dosing. There were no deaths amongst animals treated at 300 mg/kg.

Clinical signs:

other: No clinical signs were seen in animals treated at 300 mg/kg. Common clinical signs seen in animals treated at 1031 or 2000 mg/kg were piloerection, hunched posture and decreased activity. The clinical signs developed from 30 minutes after dosing and last

Gross pathology:

No abnormalities were noted at necropsy of animals that died or were killed at the end of the study.

Any other information on results incl. tables

Table 2      Mortality Data

Does Level (mg/kg)	Mortality Ratio	Time of Death after Dosing
300	0/6
1031	1/3	Day 2
2000	3/3	Day 2

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the conditions of this study, the test article was classified as Category 4 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

OECD 423 (2017) - In an acute oral toxicity study (OECD 423), groups of fasted, 8-9 week old, female Crl:WI(Han) rats were given a single oral dose of Benzenesulfonicacid, 4 -C10 -13 -sec-alkyl derivs., ammonium salts at doses 2000, 1031 and 300 mg/kg bw and observed for 14 days.

 

Oral LD₅₀ Females = >300 - 2000 mg/kg bw.

 

According to the UN GHS classification, the test item can be classified as Category 4 in respect of its acute oral toxicity.