Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

This study was designed to determine the dermal LD50 of the test item (up to 2000 mg/kg) or to establish a non-lethal dose level of 2000 milligram of test item per kilogram of body weight.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride

EC Number:

248-595-8

EC Name:

Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride

Cas Number:

27668-52-6

Molecular formula:

C26H58NO3Si.Cl

IUPAC Name:

dimethyl(octadecyl)[3-(trimethoxysilyl)propyl]azanium chloride

Details on test material:

IUPAC name: 3-(trimethoxysily)propyl) octadecyl dimethyl ammonium chloride
Smile: [Si](CCC[N+](CCCCCCCCCCCCCCCCCC)(C)C)(OC)(OC)OC.[ClH-]
InChI: 1S/C26H58NO3Si.ClH/c1-7-8-9-10-11-12-13-14-15-16-17-18-19-20-21-22-24-27(2,3)25-23-26-31(28-4,29-5)30-6;/h7-26H2,1-6H3;1H/q+1;/p-1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: National Institute of Biosciences, Pune
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation:

Male Female
Mean : 244.22 g (= 100 %)
Minimum : 241.1 g (- 1.28 %)
Maximum : 246.8 g (+ 1.06 %)
Total No. of animals : 5

Mean : 220.38 g (= 100 %)
Minimum : 217.6 g (- 1.26 %)
Maximum : 222.4 g (+ 0.92 %)
Total No. of animals : 5

- Fasting period before study: 16 hrs
- Housing: polycarbonate cages with paddy husk as bedding
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum):Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 to 21.8 degree centigrade
- Humidity (%): 56.2% to 60.1%.
- Air changes (per hr): least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters.
- Photoperiod (hrs dark / hrs light): light and dark cycle of 12 hours

IN-LIFE DATES: From: To:19-05-2017 to 28-07-2017

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: 10% of the body surface area
- Type of wrap if used: porous gauze dressing and non irritating tape used.
Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2000 mg of the test item per kilogram of body weight
- Constant volume or concentration used: yes

Duration of exposure:

24 hrs

Doses:

A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).

No. of animals per sex per dose:

Ten rats (5 male and 5 female)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recordedThe observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction:
Dermal reaction was observed daily for study period of 14 days.

Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.

Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).


Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Sex : Male
Group I -
All animals survived through the study period of 14 days.

Sex : Female
Group I -
All animals survived through the study period of 14 days.

Clinical signs:

other: Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result

Gross pathology:

Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.

Other findings:

Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.

Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.

Any other information on results incl. tables

Table No. I

Summary of Clinical Signs of Toxicity and Mortality

Laboratory Test Item Code :TAS/122/032

Test System : Sprague Dawley Rat

Sex : Male

Group  No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No clinical signs observed	5	1 - 5	Day 0 - Day 14	0/5

 

 Sex : Female

 

Group  No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No clinical signs observed	5	6 - 10	Day 0 - Day 14	0/5

Table No. II

Summary of Evaluation of Dermal Reaction

Laboratory Test Item Code :TAS/122/032

Test System : Sprague Dawley Rat

Sex : Male 

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No dermal reaction observed	5	1 - 5	Day 0 - Day 14	0/5

 

 Sex : Female

 

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No dermal reaction observed	5	6 - 10	Day 0 - Day 14	0/5

Table No.III

Mean Body Weight and Percent Body Weight Gain (g)

Laboratory Test Item Code :TAS/122/032

Test System : Sprague Dawley Rat

Sex : Male

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	244.22	270.30	10.68	295.46	9.31	20.98
		± SD	2.11	3.66	0.93	5.23	1.17	2.02

 

 

 

Sex : Female

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	220.38	236.16	7.15	247.40	4.76	12.26
		± SD	1.92	4.77	1.38	5.11	1.22	1.79

Table No.IV

Summary of Gross Pathological Findings

Laboratory Test Item Code :TAS/122/032

Test System : Sprague Dawley Rat

 

Sex : Male

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	1 - 5	TS	No abnormality detected

 

 

 

 

Sex : Female

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	6 - 10	TS	No abnormality detected

                     TS = Terminal Sacrifice

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.
CLP Classification:Not classified

Executive summary:

The reported study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats.

The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.

Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.

It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.

CLP Classification: Not classified