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Diss Factsheets

Administrative data

Description of key information

Based on the results of the read across studies and in line with its biocides assessment report, the oral and dermal LD50 values for the test substance is considered to be 350 and 2848 mg/kg bw respectively. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
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 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 (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:
ca. 398 mg/kg bw
Based on:
test mat.
95% CL:
>= 298 - <= 542
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 358 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 247 - <= 519
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 438 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 288 - <= 665
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.
Conclusions:
Under the study conditions, the rat LD50 of the read across substance was considered to be 358 mg a.i./kg bw in males, 438 mg a.i./kg bw in f emales and 398 img a.i./kg bw in males and females combined.
Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (50% active in water) according to OECD Guideline 401, in compliance with GLP. Based on the results of a range finding study, five male and five female rats per dose group weres administered the undiluted read across substance (50% active) by gavage at dose levels of 500, 794, 1260 and 2000 mg/kg bw (i.e., equivalent to 250, 397, 630 and 1000 mg a.i./kg bw). Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days. 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. One male treated with 1000 mg a.s./kg was found dead six h after dosing; all other deaths were noted one to two days after treatment. Surviving animals made expected bodyweight gains over the study period. Major signs of toxicity observed in both decedent and surviving animals were hunched posture, pilo-erection, decreased respiratory rate, diarrhoea, lethargy and ptosis. Ataxia was noted in animals treated with 397 mg a.s./kg bw and above. There were no survivors following treatment with 630 and 1000 mg a.s./kg. All surviving animals were normal three to four days after treatment.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. Under the study conditions, the LD50 of the read across substance was determined to be 358 mg a.i./kg bw (95% c.i: 247-519 mg a.s/kg bw) in males, 438 mg a.i./kg bw (95% c.i.: 288 – 665 mg a.s./kg bw) in females and 398 mg a.s./kg bw (95% c.i.: 298 – 542 mg a.s./kg bw) in male and females combined (Jones, 1986).

Based on the results of the read across study, similar or higher LD50 values can be expected for the test substance.

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
June, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, comparable to scientific principles/standards.
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
Principles of method if other than guideline:
Acute oral toxicity was determined by oral administration of the test substance to nine dose groups of male and female rats and subsequent observations of clinical signs and mortality for 14 days. The LD50 was calculated from the mortality data recorded in the study.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals:
- Age at study initiation: Young adult rats
- Weight at study initiation: 200-300 g
- Fasting period before study: 24h
- Diet: Ad libitum
- Water: Ad libitum

Route of administration:
oral: gavage
Vehicle:
other: Propylene glycol for 1 mL/kg bw and lower doses and undiluted test substance for doses 2 mL/kg bw and above dose levels.
Details on oral exposure:
Vehicle:
- Amount of vehicle: Propylene glycol for 1 mL/kg bw and all lower doses. Higher doses were administered undiluted.






Doses:
0.25, 0.32, 0.40, 0.50, 1.0, 2.0, 4.0, 8.0 and 16.0 mL/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14d
- Frequency of observations: Daily
- Necropsy of survivors performed: No
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.43 mL/kg bw
Based on:
test mat.
95% CL:
>= 0.39 - <= 0.47
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
344 mg/kg bw
Based on:
act. ingr.
Mortality:
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 groups (0.50 to 16.00 mL/kg bw) died during the study period.
Clinical signs:
other: All animals dosed at 0.25 to 0.50 mL/kg bw exhibited lethargy and slight to moderate diarrhea. The severity of the symptoms increased proportionately to the dose level received. Surviving animals returned to normal within 5 days of dosing. Animals dosed a
Interpretation of results:
other: Category 4 based on CLP criteria
Conclusions:
Under the conditions of the study, the LD50 of the read across substance was 0.43 mL/kg bw (95% c.i.-0.39 - 0.47 mL/kg bw). After correcting for 100% active test substance, the LD50 was determined to be 344 mg a.i./kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (80% active), in albino rats. The read across 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 d post-dosing. No post-mortem nor histopathological examinations were performed. All animals dosed with 0.25 to 0.50 mL/kg exhibited lethargy and slight to moderate diarrhea. The severity of the symptoms increased proportionately to the dose level received. Surviving animals returned to normal within 5 days. Animals dosed with 1.0 or 2.0 mL/kg were extremely lethargic. 0/5, 0/5 and 1/5 animals died at 0.25, 0.32 and 0.40 mL/kg bw, respectively. All animals in the higher dose levels died during the study period. Under the conditions of the study, the LD50 of the read across substance is considered to be 0.43 mL/kg bw (95% c.i.:0.39 - 0.47 mL/kg bw) in males and females combined. After correcting for 100% active read across substance, the LD50 is determined to be 344 mg a.i./kg bw (Wallace, 1975). Based on the results of the read across study, similar or higher LD50 values can be expected for the test substance.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
350 mg/kg bw
Quality of whole database:
The information requirement for this tonnage band is sufficiently met with the available data.

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
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
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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:
equivalent or similar to guideline
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
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system 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 the test substance
- Washing (if done): After removal of the dressing, animals were washed with warm water and dried.
- Time after start of exposure: After 24h

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:
24h
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: 14d
- 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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3.56 mL/kg bw
Based on:
test mat.
95% CL:
>= 3.01 - <= 4.2
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 730 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

For details please refer to the attachment under 'Attached background material'
Clinical signs:
other: 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

Table 1:

Dose levels (ml/kg)

Mortality

Time to mortality

5 0

7/8

1, 2, 7 & 12 days

4.0

6/8

2, 3, 4 & 6 days

3.0

1/8

9 days

Table 2:

Dose levels (ml/kg)

Animal #

Bodyweight (kg)

Initial

Final

5

58

2.3

2.0

4

57A

2.8

2.7

61A

2.8

2.6

3

57B

3.0

2.6

58B

2.7

2.1

59B

3.2

3.1

60B

2.7

2.4

61B

2.6

2.4

63B

2.3

1.6

64B

2.6

2.0

Conclusions:
Based on the results of the read across study, 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). After correcting for 80%purity of the active substance, the LD50 was calculated to be 2730 mg/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the read across substance, C12-16 ADBAC (80% active in water), according to a method similar to EPA OPPTS 870.1200. The experiment was performed in rabbits. The read across 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. Decreases in bodyweight were observed in all surviving animals in all treatment groups.Severe erythema and oedema at site of application observed post dosing for all animals in all groups. In the 3 mL/kg dose group (i.e. surviving animals), the erythema was followed by thickening of the skin and eschar formation across the back. Under the conditions of the study, the acute dermal LD50 of the read across substance is considered to be 3.56 mL/kg bw (95% c.i.- 3.01 - 4.20 mL/kg bw). After correcting for 80% purity of the active substance, the LD50 is calculated to be 2730 mg a.i./kg bw (Levenstein, 1977). Based on the results of the read across study, a similar or higher LD50 value can be expected for the test substance.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 848 mg/kg bw
Quality of whole database:
The information requirement for this tonnage band is sufficiently met with the available data.

Additional information

Oral

Study 1: A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (50% active in water) according to OECD Guideline 401, in compliance with GLP. Based on the results of a range finding study, five male and five female rats per dose group weres administered the undiluted read across substance (50% active) by gavage at dose levels of 500, 794, 1260 and 2000 mg/kg bw (i.e., equivalent to 250, 397, 630 and 1000 mg a.i./kg bw). Animals were observed 1 and 4 h after dosing and subsequently once daily for 14 days. 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. One male treated with 1000 mg a.s./kg was found dead six h after dosing; all other deaths were noted one to two days after treatment. Surviving animals made expected bodyweight gains over the study period. Major signs of toxicity observed in both decedent and surviving animals were hunched posture, pilo-erection, decreased respiratory rate, diarrhoea, lethargy and ptosis. Ataxia was noted in animals treated with 397 mg a.s./kg bw and above. There were no survivors following treatment with 630 and 1000 mg a.s./kg. All surviving animals were normal three to four days after treatment.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. Under the study conditions, the LD50 of the read across substance was determined to be 358 mg a.i./kg bw (95% c.i: 247-519 mg a.s/kg bw) in males, 438 mg a.i./kg bw (95% c.i.: 288 – 665 mg a.s./kg bw) in females and 398 mg a.s./kg bw (95% c.i.: 298 – 542 mg a.s./kg bw) in male and females combined (Jones, 1986). Based on the results of the read across study, similar or higher LD50 values can be expected for the test substance.

Study 2: A study was conducted to determine the acute oral toxicity of the read across substance, C12-16 ADBAC (80% active), in albino rats. The read across 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 d post-dosing. No post-mortem nor histopathological examinations were performed. All animals dosed with 0.25 to 0.50 mL/kg exhibited lethargy and slight to moderate diarrhea. The severity of the symptoms increased proportionately to the dose level received. Surviving animals returned to normal within 5 days. Animals dosed with 1.0 or 2.0 mL/kg were extremely lethargic. 0/5, 0/5 and 1/5 animals died at 0.25, 0.32 and 0.40 mL/kg bw, respectively. All animals in the higher dose levels died during the study period. Under the conditions of the study, the LD50 of the read across substance is considered to be 0.43 mL/kg bw (95% c.i.:0.39 - 0.47 mL/kg bw) in males and females combined. After correcting for 100% active read across substance, the LD50 is determined to be 344 mg a.i./kg bw (Wallace, 1975). Based on the results of the read across study, similar or higher LD50 values can be expected for the test substance.

Based on the above studies, same effect levels and toxicity potential were concluded in the biocide assessment report available on C12-16 ADBAC by RMS Italy (ECHA biocides assessment report, 2015). The RMS further made a remark about the suitability of the test substance used in the Jones, 1986 study:Although the test item is different, this result can be considered valid for C12-16-BKC, based on the similar mechanism for oral toxicity shown by QUATS with this alkyl chain length”. Lastly, a mean value of ca. 350 mg/kg bw based on both the studies was taken forward as the key conclusion for the product authorization. Therefore, in line with the biocides assessment report (ECHA biocides assessment report, 2015) and given that the read across to C12-16 ADBAC can be justified for the test substance based on a category approach, the mean oral LD50 value of 350 mg/kg bw has been considered further for hazard/risk assessment.

Inhalation

In accordance with Annex VII, Section 8.5, Column 2, of the REACH regulation, the study does not need to be conducted because the substance is classified as corrosive to the skin. Further, the substance has a low vapour pressure (VP = 2.6E-4 Pa at 25°C), which is below the cut-off of 0.01 Pa set for defining low volatility substances, as per the ECHA Guidance R.7a (2017). Therefore, due to it solid physical state and low VP, 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. 

Dermal

A study was conducted to determine the acute dermal toxicity of the read across substance, C12-16 ADBAC (80% active in water), according to a method similar to EPA OPPTS 870.1200. The experiment was performed in rabbits. The read across 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. Decreases in bodyweight were observed in all surviving animals in all treatment groups.Severe erythema and oedema at site of application observed post dosing for all animals in all groups. In the 3 mL/kg dose group (i.e. surviving animals), the erythema was followed by thickening of the skin and eschar formation across the back. Under the conditions of the study, the acute dermal LD50 of the read across substance is considered to be 3.56 mL/kg bw (95% c.i.- 3.01 - 4.20 mL/kg bw). After correcting for 80% purity of the active substance, the LD50 is calculated to be 2730 mg a.i./kg bw (Levenstein, 1977).

The biocides assessment report available for C12-16 ADBAC (ECHA biocides assessment report, 2015), had reported the active ingredient corrected LD50 value as 2848 mg a.i./kg bw. Therefore, in line with the biocides assessment report and given that the read across to C12-16 ADBAC can be justified for the test substance based on a category approach, the dermal LD50 value of 2,848 mg/kg bw has been considered further for hazard/risk assessment.

Justification for classification or non-classification

Based on the oral and dermal LD50 values from the read across studies, the test substance C16-18 ADBAC warrants an ‘Acute Tox. 4; H302: harmful if swallowed’ classification for the oral route and 'no classification' for the dermal route according to EU CLP criteria (Regulation EC 1272/2008). In addition, for the inhalation route, although C16-18 ADBAC 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: C16-18 ADBAC or QAS substances are not narcotic.