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

Endpoint summary

Description of key information

Acute Oral Toxicity: LD50 = >2,000 mg/kg; OECD 423; (Dreher D, 2017)

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:

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.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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

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

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

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

 

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.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

No mortality, no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals. This conclusion is based on a single key study with a Klimisch rating of 1.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

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

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The substance meets the Annex VIII, Section 8.5.2, Column 2 criteria as the vapour pressure is 2.08E-03 Pa. The use pattern for the substance will not present situations where exposure to aerosols, particles or droplets of an inhalable size is relevant.

Endpoint conclusion

Endpoint conclusion:

no study available

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 does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.5.3, Column 2 of REACH, testing by the dermal route does not need to be conducted  since the substance does not meet the criteria for classification as acutely toxic in oral toxicity study and no systemic effects have been observed in in vivo studies with dermal exposure (skin sensitisation OECD 429).

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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.

 

No mortality, no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals with reported oral LD50 estimated to be greater than 2000 mg/kg bw.  The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.

Justification for classification or non-classification

The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.