Registration Dossier

Administrative data

Description of key information

The available data on the read-across substance C12-16 ADBAC indicates acute oral LD50 values ranging from 344 to 397.5 mg a,i./kg bw and a dermal LD50 value of 3,412 mg a.i./kg bw. Due to the substance’s corrosive effect, there is danger of irreversible damage to the skin upon exposure to the undiluted solution. Inhalation of aerosols of inhalatory size (≤ 5µm) is not considered plausible. Prolonged exposures to generated aerosol, with MMAD of 0.8 µm for 4 hours has shown to be lethal due pulmonary oedema caused by its local corrosive properties.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 07 November, 1987 to 03 December, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
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
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 of test substance is equivalent to 397.5 mg a.i./kg bw)

Surviving animals made expected body weight gains over the study period.

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.

LD50 = 795 mg/kg bw for male and females combined. (95% confidence levels 585 - 1081)

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the LD50 of the test substance was determined to be 795 mg/kg bw (i.e., equivalent to 397.5 mg a.i./kg bw) for male and females combined, with 95% confidence levels of 585 - 1081.
Executive summary:

A guideline study was conducted in rats to determine the acute oral toxicity of C12-16 ADBAC. Five males and five females per dose group were administered undiluted test substance (50% pure) 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 days. 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. Under the study conditions, the LD50 was determined to be 795 (i.e., equivalent to 397.5 mg a.i./kg bw) for male and females combined with 95% confidence levels of 585 - 1081 (Jones JR and Collier TA, 1986).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
397.5 mg/kg bw
Quality of whole database:
Reliable guideline compliant acute oral toxicity studies are available meeting the tonnage information requirements.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 21 February, 1990 to 30 April, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to the OECD guideline 403, EPA OPP 81-3 as well as in compliance with GLP. Tested substance was a mixture of two substances.
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd., Margate, UK
- Weight at study initiation: ca. 200 g on the d of exposure
- Housing: 5/sex in polypropylene cages with detachable wire mesh tops and floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 35-65

IN-LIFE DATES: From 21 February, 1990 to 30 April, 1990
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: perspex whole body chamber (square section with pyramidal top)
- Exposure chamber volume: ca. 120 L
- Method of holding animals in test chamber: wire mesh partitions to provide 10 separate animal compartments
- Source and rate of air: filtered and oil-free compressed air
- Method of conditioning air: dried
- System of generating particulates/aerosols: atomiser
- Method of particle size determination: cascade impaction (Andersen mini-sampler and Marple cascade impactor (model 296)
- Treatment of exhaust air: passage through a collection filter
- Temperature, humidity, pressure in air chamber: temperature measured at 30-min intervals (22-23°C), relative humidity not measured (reason: aqueous solution). However, as dried air was used and the test substance contained only 7.7% water, relative humidity could have been measured. Pressure in air chamber: not indicated. However, as the whole body chamber was placed in a hood, this is not as important.

TEST ATMOSPHERE
- Brief description of analytical method used:
Five air samples (5 L for groups 2 and 4 (0.34 and 0.24 mg/L), 10 L for group 3 (0.17 mg/L) were taken from the chamber during each exposure and the collected material was analysed to determine the concentration of the test substance in the chamber air. Each air sample was withdrawn, at 4 L per min, through a weighed glass fibre filter (Whatman GF/A) mounted in an open face filter holder. The volume of the air sample was measured with a wet-type gas meter. Two further air samples were taken using an Andersen mini-sampler or a series 290 Marple cascade impactor (Model 296), and the collected material was weighed to determine the particle size distribution of the test subtance. The samples were taken at approximately 1.5 and 3.5 h from the start of exposure. The filters from the open face sampler were transferred to extraction columns and compacted with a glass road. The test substance was eluted with five 2 mL portions of methanol into a 20 mL volumetric flask and diluted to volume with methanol.
The filters from the Andersen and Marple samplers were similarly treated t o give a final volume of 5 mL. The stages of the Andersenand Marple samplers were washed off with small amounts of methanol into 5 mL volurnentric flasks. The extracts were diluted with mobile phase to obtain solutions for HPLC-analysis with expected maximum concentrations of the test substance of 150 pg/mL.

- Samples taken from breathing zone: taken from the whole body chamber.

VEHICLE: not used

TEST ATMOSPHERE (if not tabulated)
Concentrations:
0.34 mg/L (± 6%); nominal: 2.21 mg/L
0.17 mg/L (± 13%); nominal: 0.52 mg/L
0.24 mg/L (± 17%); nominal: 0.88 mg/L

- MMAD (mass median aerodynamic diameter) / GSD (geometric standard deviation):
0.34 mg/L : MMAD 1.9 µm, gsd 3.5
0.17 mg/L : MMAD 1.1 µm, gsd 2.7
0.24 mg/L : MMAD 0.8 µm, gsd 0.8

Analytical verification of test atmosphere concentrations:
yes
Remarks:
HPLC
Duration of exposure:
4 h
Concentrations:
0, 0.17, 0.24 and 0.34 mg/L
No. of animals per sex per dose:
5 per sex per concentration
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 21 d
- Frequency of observations and weighing: observations continuously duringe exposure and at least twice daily thereafter; BW daily
- Food and water intake: daily
- Necropsy of survivors performed: yes
- Other examinations performed: lung weight, histopathology of lungs, liver and kidneys
Statistics:
LC50 determination by log probit method of Miller LC and Tainter ML, Proc. Soc. Exp. Bio. Med., 57(2),1944:261-264.
Sex:
male
Dose descriptor:
LC50
Effect level:
0.22 mg/L air (analytical)
95% CL:
0.17 - 0.27
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
0.28 mg/L air (analytical)
95% CL:
0.21 - 0.35
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
0.25 mg/L air (analytical)
95% CL:
0.22 - 0.28
Exp. duration:
4 h
Mortality:
control group: 0/10
0.17 mg/L: 1 male (1/10)
0.24 mg/L: 3 males and 1 female (4/10)
0.34 mg/L: 5 males and 4 females (9/10)
Clinical signs:
other: During exposure The signs seen during exposure were considered to be consistent with inhalation of an irritant aerosol. Closing or partial closing of the eyes and exaggerated respiratory movement were seen in all rats exposed to the test subtance. Additio
Body weight:
There were moderate to marked decreases of body weight or reductions in the rate of body weight gain for up to 8 d in male rats and for up to 14 d in female rats following exposure at 0.17 mg/L or 0.24 mg/L. Subsequently weight gain for rats that survived exposure to ARMOBLEN 400 was similar to that of the control rats.
Gross pathology:
The findings for rats that died as a result of exposure to the test substance were typified by congestion of the lungs, fluid in the trachea and gas-filled stomach. Macroscopic abnormalities in a proportion of rats that survived exposure to the test substance were a swollen appearance of the lungs and gas-filled stomachs and intestines.
Other findings:
The food and water consumption for the rat that survived exposure at 0.34 mg/L was variable and reduced. Food consumption was reduced for up to 12 d following exposure to ARMOBLEN 400 at concentrations of 0.24 or 0.17 mg/L. The water consumption for these groups was reduced for up to 14 d following exposure.

The lung weight to body weight ratio was increased, due to a high lung weight, for most rats that died as a result of exposure to ARMOBLEN 400 for a few decedents and the majority of the surviving rats was increased because of low body weight.

Histopathology
Group 2 (0.34 mg/L test substance)
Decedents
Treatment-related changes were seen in the 5 male and 4 female decedents. The distribution of these lesions was as follows:
focal alveolar wall necrosis in 3 males; diffuse congestion in 3 males and 4 females; eosinophilic material in alveoli in 5 males and 4
females; alveolitis in 2 males and 4 females; focal alveolar oedema in 1 male; perivascular oedema in 4 males.
Survivors
Treatment-related changes were seen in the single female rat surviving to the end of the observation period. These were as
follows: focal alveolitis; focal bronchiolitis; prominent bronchiolar goblet cells.

Group 3 (0.17 mg/L test substance)
Decedents
Treatment-related changes were seen in the single decedent male. These were as follows: diffuse congestion; eosinophilic materialin alveoli; alveolitis; focal alveolar oedema.
Survivors
Treatment-related changes were seen in one of the 4 males and in one of the 5 females surviving to the end of the observation
period. The distribution of these lesions was as follows: focal bronchiolitis in 1male; prominent bronchiolar goblet cells in 1 male;
foreign body giant cells in 1 male; focal alveolar haemorrhage in 1 female. A focus of emphysema was also seen in one surviving
female. The significance of this finding in a single animal is unclear, but possibility that it is related to treatment cannot be excluded.
No abnormalities were detected in 3 males and 3 females surviving to the end of the observation period.

Group 4 (0.24 mg/L test substance)
Decedents
Treatment-related changes were seen in the 3 male decedents and 1 female decedent. The distribution of these lesions was as
follows: diffuse or focal congestion in 2 males and 1 female; eosinophilic material in alveoli in 2 males and 1 female; alveolitis in 1
male and 1 female; focal alveolar oedema in 1 male; focal alveolar haemorrhage in 1 female; perivascular oedema in 1 female.
Survivors
Treatment-related change was seen in one of the two males and one of the 4 females surviving to the end of the observation
period. This lesion was: foreign body giant cells. No abnormalities were detected in 1 male and 3 females surviving to the end of theobservation period.

Comment from the authors
Treatment-related changes were found in the survivors from all groups. It is not possible to predict with certainty the progression of these lesions, but the changes were minimal and of a focal nature and it is possible that they would be resolved in the course of time leaving no permanent lesions.
Interpretation of results:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 4 h LC50 of the mixture was calculated to be 0.25 mg/L (0.22 -0.28 mg/L), or based on 77.3% active material 0.32 mg Quaternary Ammonium Compounds/L.
Executive summary:

A guideline compliant study was performed to assess the acute toxicity of a mixture of C12-16 ADBAC and dicocodimethylammoniumchloride following inhalation exposure to the Sprague-Dawley rats. Four groups of ten rats each (five males and five females) were given a single, 4 -h whole body exposure at concentration levels of 0, 0.17, 0.24 and 0.34 mg/L. The animals were observed for 21 d after exposure and were then killed for gross and histopathological examination of the lungs. Body weight, food and water intake and lung weight were also determined. There were no deaths in the control group; one animal (male) died at 0.17 mg/L, four animals died at 0.24 mg/L (3 males, 1 female), and nine animals died at 0.34 mg/L (5 males, 4 females). Clinical signs of toxicity noted were (partial) closing of the eyes and exaggerated respiratory movement during exposure in all test groups, gasping and wetness around the mouth during exposure at 0.34 mg/L. Clinical signs were noted in survivors throughout the 21 d observation period. Decrease of body weight, reduced weight gain, and reduced food and water intake was generally seen up to 14 d.

Abnormalities noted at necropsy in survivors were increased relative lung weight, swollen appearance of the lungs and gas-filled stomach and intestines. Animals that died showed congestion of the lungs, fluid in the trachea, and gas-filled stomach. Histopathological lung changes in survivors generally consisted of focal alveolitis and bronchiolitis; changes in deceased animals generally consisted of focal alveolar wall necrosis, diffuse congestion, focal alveolar wall oedema and focal alveolar wallhaemorrhage.

The acute 4 h LC50 value of the test substance was found to be 0.25 mg/L (0.22 -0.28 mg/L), i.e. based on 77.3% of active material, 0.32 mg/L. (Jackson CG et.al., 1990).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
0.32 mg/m³
Quality of whole database:
4h-LC50 of 0.32 mg of QAC mixture/L. The identified inhalation hazard for aerosols with MMAD ≤ 1µm does not exists in practice. The substance is a sticky solid with a low vapour pressure. Due to its physical state and physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study, followed methods comparable to guideline EPA OPPTS 870.1200
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
1. In the study, 4 animals/sex/test group were used; however, the guideline recommends 5 animals of one sex in each test group. 2. Abraded and non abraded skin sites were used; however, guideline recommends unabraded skin. 3. Gross necropsy was not perfor
GLP compliance:
no
Remarks:
(Pre-GLP)
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 2.2 – 3.4 kg

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back of animal (10% of body surface)
- Type of wrap if used: The test sites were covered with gauze and each animal was wrapped in a sleeve after application of the test substance
- Type of test site: Intact and abraded (half of the test animals in each sex, i.e., 2 animals/sex/group had their skin abraded on one side )

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the dressing, animals were washed with warm water and dried.
- Time after start of exposure: After 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3,4 and 5 mL/kg bw
- Concentration (if solution): Undiluted (as received)
- Constant volume or concentration used: yes

Duration of exposure:
24 h
Doses:
3,4 and 5 mL/kg bw
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: The animals were observed for clinical signs, mortality and body weight (at the start of the experiment and at termination (Day 14)).
- Necropsy of survivors performed: No
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3.56 mL/kg bw
Based on:
test mat.
95% CL:
3.01 - 4.2
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 412.5 mg/kg bw
Based on:
act. ingr.
Mortality:
Mortality observed at each dose levels:
3 mL/kg bw: 1/8
4 mL/kg bw: 6/8
5 mL/kg bw: 7/8
Clinical signs:
Severe erythema and oedema was observed post dosing at the sites of application for all animals in all groups. In the 3 mL/kg bw dose group (i.e., surviving animals), the erythema was followed by thickening of the skin and eschar formation across the back.
Body weight:
A decrease in bodyweight was observed in all surviving animals in all the treatment groups.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the acute dermal LD50 of the test substance was found to be 3.56 mL/kg bw (95% c.i.- 3.01 - 4.20 mL/kg bw) and after correcting for purity of the active substance, the LD50 was calculated to be 3,412.5 mg/kg bw in rabbits.
Executive summary:

A guideline equivalent study was conducted to determine the acute dermal toxicity of C12-16 ADBAC 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) to 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 of the test substance for a 24-hour 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 days. 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. Under the test conditions, the LD50 of C12-C16 ADBAC was found to be 3.56 mL/kg bw (95% c. i. - 3.01 - 4.20 mL/kg bw) and, after correcting for purity of the active substance, the LD50 was 3,412.5 mg a.i./kg bw (Levenstein I, 1977).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 412 mg/kg bw
Quality of whole database:
Due to the corrosive effect, there is a danger of irreversible damage to the skin upon exposure to the undiluted solution. Toxicity is secondary to the local tissue damage, rather than the result of percutaneously absorbed material.

Additional information

Oral

A guideline study was conducted in rats to determine the acute oral toxicity of the read-across substance C12-16 ADBAC.Five males and five females per dose group were administered undiluted test substance (50% pure) in a single oral dose by gavage at the dose levels of 500, 794, 1,260 and 2,000 mg/kg bw. Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths 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 was determined to be 795 mg/kg bw (equivalent to 397.5 mg a.i./kg bw) for male and females combined (Jones JR and Collier TA, 1986).

The acute oral toxicity of the read-across substance C12-16 ADBAC in albino rats was assessed in another study.The test substance was administered to groups of five fasted male and female albino rats at 0.25, 0.32, 0.40, 0.50, 1.0, 2.0, 4.0, 8.0 or 16.0 mL/kg bw. Propylene glycol was used as vehicle for 1 mL/kg and all lower doses. Doses of 2 mL/kg bw and above were administered as received. Animals were observed for 14 days post-dosing. No postmortem or histopathological examinations were performed.0/5, 0/5 and 1/5 animals died at 0.25, 0.32 and 0.40 mL/kg bw dose levels respectively. All animals in the higher dose levels died during the study period. Under the test conditions, the LD50 of C12-16 ADBAC in albino rats was found to be 0.43 mL/kg bw (equivalent to 344 mg a.i./kg bw) (Wallace JM, 1975).

Dermal

A guideline equivalent study was conducted to determine the acute dermal toxicity of the read-across substance C12-16 ADBAC 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) to 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 of the test substance for a 24 hour 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 days. 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. Under the test conditions, the LD50 of C12-16 ADBAC was found to be 3.56 mL/kg bw (i.e. 3,412.5 mg a.i./kg bw) (Levenstein I, 1977).

Inhalation

A guideline compliant study was performed to assess the acute toxicity of a mixture of C12-16 ADBAC and dicocodimethylammoniumchloride (MMAD ≤ 1µm) following inhalation exposure to the Sprague-Dawley rats. Four groups of ten rats each (five males and five females) were given a single, 4 hour whole body exposure at concentration levels of 0, 0.17, 0.24 and 0.34 mg/L. The animals were observed for 21 days after exposure and were then culled for gross and histopathological examination of the lungs. Body weight, food and water intake and lung weight were also determined. There were no deaths in the control group; one animal (male) died at 0.17 mg/L, four animals died at 0.24 mg/L (3 males, 1 female), and nine animals died at 0.34 mg/L (5 males, 4 females). Clinical signs of toxicity noted were (partial) closing of the eyes and exaggerated respiratory movement during exposure in all test groups, gasping and wetness around the mouth during exposure at 0.34 mg/L. Clinical signs were noted in survivors throughout the 21 day observation period. Decrease of body weight, reduced weight gain, and reduced food and water intake was generally seen up to Day 14. Abnormalities noted at necropsy in survivors were increased relative lung weight, swollen appearance of the lungs and gas-filled stomach and intestines. Animals that died showed congestion of the lungs, fluid in the trachea, and gas-filled stomach. Histopathological lung changes in survivors generally consisted of focal alveolitis and bronchiolitis; changes in deceased animals generally consisted of focal alveolar wall necrosis, diffuse congestion, focal alveolar wall oedema and focal alveolar wall haemorrhage. The acute 4 h LC50 value of the test substance was found to be 0.25 mg/L, i.e. based on 77.3% of total active substance, 0.32 mg/L. (Jackson CG et.al., 1990).

The substance is a solid with a low vapour pressure. Due to it physical state and physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) 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 selection of acute toxicity – oral endpoint
Most recent and robust study (composition of test substance is given which is lacking in most of other acute studies), OECD guideline and GLP compliant study.

Justification for selection of acute toxicity – inhalation endpoint
Although not on the substance itself, it is the only study available providing information on inhalation toxicity for QAC in aerosols at MMAD ≤ 1µm.

Justification for selection of acute toxicity – dermal endpoint
Appropriate study of the highest quality and validity.

Justification for classification or non-classification

Oral

Based on the oral LD50value of 397.5 mg a.i./kg bw for the read-across substance C12-16 ADBAC, Xn; R22 (harmful if swallowed) classification is warranted according to DSD criteria (67/548/EEC). The corresponding classification according to CLP criteria (EC 1272/2008) is Acute Tox. 4; H302: Harmful if swallowed.

Dermal

Based on the dermal LD50 value of 3,412 mg a.i./kg bw for the read-across substance C12-16 ADBAC, no classification is warranted for this endpoint according to DSD (67/548/EEC) and CLP (EC 1272/2008) criteria.

Inhalation

The identified inhalation hazard for aerosols of a quaternary ammonium compound mixture with MMAD ≤ 1µm does not exists in practice. No classification is warranted according to DSD (67/548/EEC) and CLP (EC 1272/2008) criteria.