Benzyldimethyl(octadecyl)ammonium chloride

Endpoint summary

Description of key information

Based on the results the read across studies, the oral and dermal LD50 value of the test substance, C18 ADBAC is considered to be 397.5 mg/kg bw and 3412.5 mg/kg bw respectively.

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From November 07, 1987 to December 03, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

other: Acute oral toxicity

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: undiluted test substance

Doses:

500, 794, 1,260 and 2,000 mg/kg bw

No. of animals per sex per dose:

10

Details on study design:

Dose selection was based upon the results of a range-finding study. Animals, 5 males and 5 females per dose group, were administered the undiluted test substance in a single oral dose by gavage. Animals were observed 1 and 4h after dosing and subsequently once daily for 14 d. Deaths and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the d of treatment (Day 0), Days 7 and 14, and at death. All animals were subjected to gross necropsy examination for any macroscopic abnormalities.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

795 mg/kg bw

Based on:

test mat.

95% CL:

>= 585 - <= 1 081

Remarks on result:

other: (795 mg/kg bw equivalent to 397.5 mg a.i./kg bw

Gross pathology:

Necropsy of decedents revealed abnormally red lungs, dark livers, haemorrhage and ulceration of the gastric mucosa and congestion of the small intestines. Major abnormalities seen at necropsy of animals killed at termination were white thickened areas of the non-glandular region of the stomach. Scattered white raised areas were also noted.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based on the results from the study, the LD50 was determined to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females.

Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (active: 50%), according to OECD Guideline 401, in compliance with GLP. Five male and five female rats per dose group were administered the undiluted test substance (50% purity) in a single oral dose by gavage at the dose levels of 500, 794, 1260 and 2000 mg/kg bw. Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 d. Mortality and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the day of treatment (Day 0), Days 7 and 14, and at termination. All animals were subjected to gross necropsy examination for any macroscopic abnormalities. Under the study conditions, the LD50 of the read across substance was considered to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females combined, with 95% confidence levels of 585 - 1081 (Jones, 1986). Based on the results of the read across study, similar oral LD50 value can be considered for the test substance, C18 ADBAC, for acute oral toxicity in rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

397.5 mg/kg bw

Quality of whole database:

Guideline compliant 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:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

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:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Oral:

A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (active: 50%), according to OECD Guideline 401, in compliance with GLP. Five male and five female rats per dose group were administered the undiluted test substance (50% purity) in a single oral dose by gavage at the dose levels of 500, 794, 1260 and 2000 mg/kg bw. Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 d. Mortality and evidence of overt toxicity were recorded at each observation. Individual body weights were recorded on the day of treatment (Day 0), Days 7 and 14, and at termination. All animals were subjected to gross necropsy examination for any macroscopic abnormalities. Under the study conditions, the LD50 of the read across substance was considered to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females combined, with 95% confidence levels of 585 - 1081 (Jones, 1986). Based on the results of the read across study, similar oral LD50 value can be considered for the test substance, C18 ADBAC, for acute oral toxicity in rats.

Dermal:

A study was conducted to determine the acute dermal toxicity of the read across substance, C12-16 ADBAC (active: > 93%), according to a method similar to EPA OPPTS 870.1200. The experiment was performed in rabbits. The test substance was applied to twelve male and twelve female rabbits (4 animals/sex/test group) at dose levels of 3, 4 and 5 mL/kg bw (single application) on the abraded and intact skin of the back. The test sites were covered with gauze and each animal was wrapped in a sleeve after application for a 24 h period. After removal of the dressing, animals were washed with warm water and dried. The animals were observed for clinical signs and mortality for 14 d. Body weights were determined at the start of the experiment and at termination (Day 14). In the study, 1/8, 6/8 and 7/8 animals died at 3, 4 and 5 mL/kg bw, respectively. Based on the results of the study, the acute dermal LD50 of the test substance is considered to be 3.56 mL/kg bw (95% c.i.- 3.01 - 4.20 mL/kg bw). After correcting for purity of the active substance, the LD50 is calculated to be 3412.5 mg/kg bw (Levenstein, 1977). Based on the results of the read across study, similar dermal LD50 can be considered for the test substance, C18 ADBAC, for acute dermal toxicity to rabbits.

Inhalation:

The substance is a solid 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 humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for classification or non-classification

Based on the results of the read across studies, the test substance, C18 ADBAC is considered to warrant classification for the oral route as 'Acute tox. 4; H302: Harmful if swallowed classification' and no classification for the dermal route according to EU CLP criteria (Regulation 1272/2008/EC).​