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Description of key information

Acute Toxicity: Oral

The acute oral toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study conducted according to theConsumer Product Safety Commission 16 CFR 1500.

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Under the conditions of the study the LD50 was determined to be 1710 mg/kg bw and, as a consequence, the substance is classified as a Category 4, harmful if swallowed according to the GHS criterial ( Regulation [EC] No 1272/2008 of the European Parliament and of the Council of 16 December 2008).

Acute Toxicity: Inhalation

Waiver

Acute toxicity: Dermal

The acute dermal toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study for which no guideline is available and details of the study design and results are noted to be inadequate.

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 3 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Under the conditions of the study the dermal LD50 was determined to be < 2500 mg/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:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Inadequate study details and results
Justification for type of information:
Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.
Qualifier:
according to guideline
Guideline:
other: Consumer Product Safety Commission 16 CFR 1500
Deviations:
yes
Remarks:
Only 5 animals per group
GLP compliance:
no
Test type:
standard acute method
Specific details on test material used for the study:
The product tested was a gold liquid which was stored in an airtight container at room temperature from receipt throughout the study period.

(Similar to C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) 75% a.i. with only water, no IPA [isopropanol])
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Five male SpragueDawley derived albino rats from Hilltop Lab Animals, Inc., weight ranging from 200 to 265 grams.

Food was witheld from the rats for approximately 18 hours prior to dosing. Following dosing, food consisting of PURINA LABORATORY CHOW and water were available ad libitum. The rats were housed in groups in stainless steel wire mesh cages suspended above the droppings. The animals were housed under a 12-hour light/12-hour dark cycle. The rats were acclimated to the laboratory at least seven days prior to dosing and were individually identified by numbered ear tags and tail marks with permanent ink.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test sample was administered by esophageal intubation to five groups, each composed of five male Sprague-Dawley derived albino rats from Hilltop Lab Animals, Inc., weight ranging from 200 to 265 grams. Four groups were treated on April 1, 1981, and the fifth group was treated on April 8, 1981. The sample was administered undiluted at dosage levels of 0.464, 1.00, 2.15, 4.64, and 10.0 grams per kilogram of body weight using an average density value of 1.036 g/ml for administration on a sample volume basis.
Doses:
0.464, 1.00, 2.15, 4.64, and 10.0 grams per kilogram of body weight
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
All animals were observed closely for gross signs of systemic toxicity and mortality at one and one-half to two hours, three and three-quarter to four and one-quarter hours, and give and one-half to six hours post administration during the day of dosing, and at least once daily thereafter for a total of 14 days. Gross necropsies were performed on the animals that died. At the end of the 14-day observation period the surviving rats were weighed, sacrificed by C02 inhalation and gross necropsies were performed. Statittical analysis of the mortality data was by the moving average method.
Statistics:
moving average method
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 710 mg/kg bw
95% CL:
> 1.26 - < 2.33
Clinical signs:
The results of the observations for gross signs of systemic toxicity noted throughout the study at the various dosage levels showed central nervous system depression, piloerection, and diarrhea were found in all animals and persisted up to four days in surviving animals. Sporadic occurrences of emaciation, anal exudate, and oily matted fur were observed in one rat each from the 0.464 and 2.15 g/kg dosage levels. A second rat from the 0.464 g/kg level exhibited a swollen right eye on day 4. Squinting of the eyelids was noted in the group which received 10.0 g/kg both before and after treatment. The most prevalent findings included nasal discharge and diarrhea staining externally and excessive gas with a green-yellow colored liquid in the gastrointestinal tract internally.
Body weight:
All animals which survived the observation period gained weight.
Gross pathology:
Gross necropsies performed at the termination of the study revealed no gross pathological alterations or lesions in any of the surviving animals.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on these results, the product tested (75 % C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) and 25% water) is classfied as harmful by oral ingestion as that term is defined in the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.

Based on the concentration of the product, the same classification is valid for the active ingredient C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2).
Executive summary:

The acute oral toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study conducted according to the Consumer Product Safety Commission 16 CFR 1500.

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Under the conditions of the study the LD50 was determined to be 1710 mg/kg bw and, as a consequence, the substance is classified as a Category 4, harmful if swallowed according to the GHS criterial ( Regulation [EC] No 1272/2008 of the European Parliament and of the Council of 16 December 2008).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 710 mg/kg bw

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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1958
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: non-interpretable for classification; Incomplete report; Inadequate details of study design and results; Composition uncertain
Justification for type of information:
Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.
Version / remarks:
No guideline available; inadequate details of study design and results
Principles of method if other than guideline:
No guideline available; inadequate details of study design and results
GLP compliance:
no
Test type:
other: Inadequate details of study design and results
Limit test:
no
Specific details on test material used for the study:
67.2% active
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Single dermal dose
Duration of exposure:
24 hours
Doses:
2.5 g/kg
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
No data
Statistics:
No data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
< 2 500 mg/kg bw
Mortality:
Two animals died within 36 hours and two succumbed within 48 to 56 hours after percutaneous application.
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No significant abnormalities were noted at autopsy other than local reactions. These local skin reactions were, however, quite severe. The skin became dry, wrinkled, and encrusted; necrosis had commenced prior to death.

The solvent (isopropanol) conceivably may have played an indirect role in promoting the absorption of the active ingredient through the skin, but it is unlikely that it directly affected the percutaneoas toxicity to any great extent. On the basis of active ingredient, the dose was 1. 68 g/kg. The dose of solvent (isopropanol) given was 0.82 g/kg. This latter value is considerably below the percutaneous LD50 for isopropanol (16. 4 ml/kg).

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 was less than 2.5 g/kg.
Executive summary:

The acute dermal toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study for which no guideline is available and details of the study design and results are noted to be inadequate.

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 3 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Under the conditions of the study the dermal LD50 was determined to be < 2500 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

Justification for classification or non-classification

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