Hexadecyltrimethylammonium methyl sulphate

Endpoint summary

Description of key information

Based on the results of the read across study, the acute LD50 of the test substance in male/female rats for the test substance is considered to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

July 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

KL2 due to RA

Justification for type of information:

Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, 69210 L'arbresle, France
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 178 +/- 7 g for males, 159 +/- 8 g for females
- Fasting period before study: 1 day
- Housing: housed in groups by sex
- Diet (e.g. ad libitum): "Rats et Souris entretien référence A04C" (U.A.R., 9160 Villemoisson-sur-Orge, Fance)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Males:
- 600 mg/kg (10 mL/kg)

Females:
- 200 mg/kg (10 ml/kg)
- 500 mg/kg (10 ml/kg)
- 750 mg/kg (15 ml/kg)
- 1,000 mg/kg (20 ml/kg)

No. of animals per sex per dose:

5 animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 d for females and 21 d for males
- Frequency of observations and weighing: Animals observed for clinical signs and mortality at frequent intervals on Day 1 and twice daily thereafter; body weight measured on Day 1, 8, 15 and 22.
- Necropsy of survivors performed: yes, animals were sacrificed by CO2.
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 600 mg/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 570 mg a.i./kg bw

Mortality:

Females: No mortality observed at 200 mg/kg. 20, 80 and 100% mortality observed at 500, 750 and 1,000 mg/kg bw, respectively.
Males: 20% mortality observed at 600 mg/kg bw.

Clinical signs:

other: Females: - 200 and 500 mg/kg: hypoactivity on 4/5 animals on the day of administration. - 750 mg/kg: sedation, hypoactivity, lateral decubitus, dyspnoea, piloerection - 1,000 mg/kg: sedation, hypoactivity, piloerection, contaminated uro-vaginal area Mal

For details, kindly refer to the attached background material section of the IUCLID.

Interpretation of results:

other: Acute Tox. 4 based on CLP criteria

Conclusions:

Based on the results of the read across study, the acute LD50 of the test substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw).

Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, C12-14 ADMAES (> 95% active), in Sprague-Dawley rats according to OECD 401 Guideline. Groups of five Sprague-Dawley rats (5/dose) received a single oral (gavage) dose of 600 mg/kg bw of the read across substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 or 21 day observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg in females and 600 mg/kg in males. Under the study conditions, the acute oral median lethal dose (LD50) of the read across substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw) (Molinier, 1995). Based on the results of the read across study, similar LD50 value is expected for the test substance.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

570 mg/kg bw

Quality of whole database:

A reliable good quality study.

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 the substance is classified as corrosive to the skin

other:

Reason / purpose for cross-reference:

data waiving: supporting information

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 is classified as corrosive to the skin

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

 

A study was conducted to determine the acute oral toxicity of the read across substance, C12-14 ADMAES (> 95% active), in Sprague-Dawley rats according to OECD 401 Guideline. Groups of five Sprague-Dawley rats (5/dose) received a single oral (gavage) dose of 600 mg/kg bw of the read across substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 or 21 day observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg in females and 600 mg/kg in males. Under the study conditions, the acute oral median lethal dose (LD50) of the read across substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw) (Molinier, 1995). Based on the results of the read across study, similar LD50 value is expected for the test substance.

Inhalation:

In accordance with Annex VII, Section 8.5, Column 2, additional acute toxicity study for inhalation route does not need to be conducted because the substance is classified as corrosive to the skin. Further, the substance is a solid (flakes) with a low vapour pressure at room temperature. Due to its physical state and physical chemical properties it is unlikely that this substance will form inhalable dust, mist or fumes during normal processing and use conditions. In case inhalable forms of the substance are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humansfollowing inhalation exposurecan be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation. 

Dermal:

In accordance with Annex VII, Section 8.5, Column 2, additional acute toxicity study for dermal route does not need to be conducted because the substance is classified as corrosive to the skin.

Justification for classification or non-classification

Based on the results of the read across studies, the test substance,C16 TMA-MS, is considered to be classified as 'Acute Tox.4, H302: harmful if swallowed' for oral route and 'Acute Tox.3, H311: toxic in contact with skin' for dermal route, according to the EU CLP criteria (Regulation EC 1272/2008). In addition, for the inhalation route, although C16 TMA MS is classified to be corrosive (see section 5.3) and this drives its mechanism of action of toxicity, its inherent low vapour pressure prohibits the occurrence of respiratory irritation or corrosion by vapour. Therefore, it does not warrant an additional labelling as: EUH071 — ‘Corrosive to the respiratory tract’ according to EU CLP criteria (Regulation EC 1272/2008).

Further, the available data does not show indication that classification for STOT-SE cat 1 or 2 is indicated. For STOT-SE Cat 3: C16 TMA MS or QAS substances are not narcotic.