Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 March 2017 - 20 November 2017

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

Report date:

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:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-14-branched alkyl, octylbenzenesulfonates (1:1)

Molecular formula:

Amines, C12-branched alkyl, octylbenzenesulfonates: C27H51NO3S Amines, C13-branched alkyl, octylbenzenesulfonates: C28H53NO3S Amines, C14-branched alkyl, octylbenzenesulfonates: C29H55NO3S

IUPAC Name:

Amines, C12-14-branched alkyl, octylbenzenesulfonates (1:1)

Constituent 2

Reference substance name:

Amines, C12-14-branched alkyl, nonylbenzenesulfonates (1:1)

Molecular formula:

Amines, C12-branched alkyl, nonylbenzenesulfonates: C28H53NO3S Amines, C13-branched alkyl, nonylbenzenesulfonates: C29H55NO3S Amines, C14-branched alkyl, nonylbenzenesulfonates: C30H57NO3S

IUPAC Name:

Amines, C12-14-branched alkyl, nonylbenzenesulfonates (1:1)

Constituent 3

Reference substance name:

Amines, C12-14-branched alkyl, decylbenzenesulfonates (1:1)

Molecular formula:

Amines, C12-branched alkyl, decylbenzenesulfonates: C29H55NO3S Amines, C13-branched alkyl, decylbenzenesulfonates: C30H57NO3S Amines, C14-branched alkyl, decylbenzenesulfonates: C31H59NO3S

IUPAC Name:

Amines, C12-14-branched alkyl, decylbenzenesulfonates (1:1)

Constituent 4

Reference substance name:

Amines, C12-C14-branched alkyl, benzenesulfonates C12-C15 (1:1)

Molecular formula:

Amines, C12-branched alkyl, benzenesulfonates C12 (1:1) C31H59NO3S Amines, C12-branched alkyl, benzenesulfonates C13 (1:1) C32H61NO3S Amines, C12-branched alkyl, benzenesulfonates C14 (1:1) C33H63NO3S Amines, C12-branched alkyl, benzenesulfonates C15 (1:1) C34H65NO3S Amines, C13-branched alkyl, benzenesulfonates C12 (1:1) C32H61NO3S Amines, C13-branched alkyl, benzenesulfonates C13 (1:1) C33H63NO3S Amines, C13-branched alkyl, benzenesulfonates C14 (1:1) C34H65NO3S Amines, C13-branched alkyl, benzenesulfonates C15 (1:1) C35H67NO3S Amines, C14-branched alkyl, benzenesulfonates C12 (1:1) C33H63NO3S Amines, C14-branched alkyl, benzenesulfonates C13 (1:1) C34H65NO3S Amines, C14-branched alkyl, benzenesulfonates C14 (1:1) C35H67NO3S Amines, C14-branched alkyl, benzenesulfonates C15 (1:1) C36H69NO3S

IUPAC Name:

Amines, C12-C14-branched alkyl, benzenesulfonates C12-C15 (1:1)

Constituent 5

Reference substance name:

Amines, C12-14-branched alkyl, hexadecylbenzenesulfonates (1:1)

Molecular formula:

Amines, C12-branched alkyl, hexadecylbenzenesulfonates (1:1): C35H67NO3S Amines, C13-branched alkyl, hexadecylbenzenesulfonates (1:1): C36H69NO3S Amines, C14-branched alkyl, hexadecylbenzenesulfonates (1:1): C37H71NO3S

IUPAC Name:

Amines, C12-14-branched alkyl, hexadecylbenzenesulfonates (1:1)

Constituent 6

Reference substance name:

Residual Amines, C12-14-tert-alkyl

IUPAC Name:

Residual Amines, C12-14-tert-alkyl

Test material form:

liquid: viscous

Details on test material:

Storage: Room Temperature

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: The weight variation did not exceed ± 20 %of the mean weight.
- Fasting period before study: Yes, evening before dosing (Day -1)
- Housing: The animals were housed in groups of up to five during the acclimatisation period in suspended, solid floor cages with wire lids. 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: The condition of the animals was assessed daily throughout the acclimatisation period of 8 to 10 days. A second inspection was performed prior to study commencement to ensure the animals were suitable for the study. Overtly healthy animals were arbitrarily allocated to the study groups at least one day prior to dosing.

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

IN-LIFE DATES: From: 14 March 2017 To: 07 April 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Test item not soluble in water. Corn oil is a guideline accepted alternative vehicle.
- Lot/batch no. (if required): Not reported
- Purity: Not reported

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION (if unusual): The test article was dispersed in corn oil. The test article did not dissolve / suspend in purified water, but a visibly clear, yellow coloured solution was achieved in corn oil. 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 maintained on a magnetic stirrer for at least 30 minutes prior to administration to ensure homogeneity.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: N/A

Doses:

2000 mg/kg (limit test)

No. of animals per sex per dose:

Females: 2 groups of 3 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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 body weights were recorded on Day-1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, necropsy (necropsy procedure included inspection of external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines).

Statistics:

Not required

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no deaths observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

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

Other findings:

N/A

Any other information on results incl. tables

Table 2       Number of animals dead (and with evident toxicity)

 

Dose (mg/kg bw)	Mortality (# dead / total)			Time range of deaths (hours)	Number with evident toxicity (# / total)
	Male	Female	Combined		Male	Female	Combined
2000	-	0 / 6	0 / 6	n/a	-	0 / 6	0 / 6

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test article, Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1), was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

OECD 423 (2017) - In an acute oral toxicity study, a group of fasted, 8-9 week old female, nulliparous Wistar rats were given a single oral dose of Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) at a single dose rate of 2000 mg/kg bw (limit test) and observed for 14 days.

 

In the absence of mortality during the observation period, the oral LD₅₀was estimated to be greater than 2000 mg/kg bw.

 

In addition, there were no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals.

 

Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.