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EC number: 947-349-3 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27/06/2016-19/07/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[dimethyl({3-[(10E,13E)-nonadeca-10,13-dienamido]propyl})azaniumyl]acetate
- Molecular formula:
- C25H47N2O3 (if R= C18:2)
- IUPAC Name:
- 2-[dimethyl({3-[(10E,13E)-nonadeca-10,13-dienamido]propyl})azaniumyl]acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The test material corresponded to the approximately 45% of the registration substance. The given dose refers to the amount of the registration substance.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sainath Agencies, Bapujinagar, Musheerabad, Hyderabad 500 020
- Age at study initiation: 8 - 9 Weeks
- Weight at study initiation: Females: 211.6 to 229.2 g & Males: 235.8 to 266.8 g
- Housing:Animals were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage at least once a week. Bedding: steam sterilized corn cob was used and changed once a week along with the cage.
- Diet (ad libitum):Hypro Rat & Mice Pellet Feed, manufactured by Pranav Agro Industries Ltd., Pune 411 030, Maharashtra, India, was provided to animals.
- Water (ad libitum):Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India was provided to animals in polycarbonate bottles with stainless steel sipper tubes.
- Acclimation period: After physical examination, the animals were acclimatized for five days for females and seven days for males before treatment. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%):65 to 67%
- Air changes (per hr):12.9 to 13.1 air changes/hour
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours dark cycle
IN-LIFE DATES: From: 27 May 2016 To: 17 June 2016
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The applied dose level refers to the active ingredient, the registration substance.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10 x 8 cm
- % coverage: 10%
- Type of wrap if used: Adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: after 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Refer Table 1.
Based on the individual body weight, the undiluted test item at the dose of 2000 mg/kg body weight and dose volume was 4.52 mL/kg body weight
[1.90 mL/kg (dose volume as per density) x 2.38 (correction factor)] was calculated based on the density of the test item i.e., 1.05 g/cm3 (as per TIDS provided by the sponsor). For example, for rat Rm4741, the body weight was 222.4 g, the dose volume administered was 0.87 mL [i.e., body weight of rat 222.4 g x dose volume 4.52 mL/kg / 1000 = 222.4 x 4.52 / 1000 = 1.005 mL rounded off to 1.01 mL]
- Concentration (if solution): Undiluted test item - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs and pre-terminal deaths (mortality) four times (at hourly intervals after application) during day 1 and twice daily on day 2 and 3 and once daily during days 4 to 15. Individual body weights of animals were recorded on test days 1 (Pre-application), 8 (7 days post application), and 15 (14 days post application).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.
Results and discussion
- Preliminary study:
- Body weights, body weight changes and pre-terminal deaths are presented in Tables 1.
Individual clinical signs of toxicity and necropsy findings are presented in Table 2.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No Mortality
- Clinical signs:
- other: Refer Table 2. There were no clinical signs observed during the study. However, in females, the skin reactions of erythema, edema, scale formation, peeling/desquamation were observed during days 3 to 10 post dose application. The rat numbers Rm4741 and Rm
- Gross pathology:
- No abnormalities detected.
Any other information on results incl. tables
Table 1. Individual Body Weight, Body Weight Changes and Pre-Terminal Deaths
Group and Dose (mg/kg body weight) |
Rat No. |
S e x |
Body weight (g) |
No. dead / No. tested |
Pre- terminal deaths (%) |
||||
Day 1 Initial (at treatment) |
8th day |
Weight change (day 8 – Initial) |
15th day |
Weight change (day 15 – Initial) |
|||||
G1 2000 (4.52 mL/kg)*
|
Rm4741 |
F |
222.4 |
231.6 |
9.2 |
239.8 |
17.4 |
0/10 |
0 |
Rm4742 |
F |
229.2 |
242.3 |
13.1 |
247.6 |
18.4 |
|||
Rm4743 |
F |
224.6 |
230.3 |
5.7 |
236.9 |
12.3 |
|||
Rm4744 |
F |
211.6 |
218.9 |
7.3 |
222.7 |
11.1 |
|||
Rm4745 |
F |
218.2 |
229.5 |
11.3 |
238.5 |
20.3 |
|||
Rm4746 |
M |
235.8 |
247.2 |
11.4 |
259.4 |
23.6 |
|||
Rm4747 |
M |
240.3 |
251.9 |
11.6 |
263.1 |
22.8 |
|||
Rm4748 |
M |
266.8 |
276.9 |
10.1 |
287.5 |
20.7 |
|||
Rm4749 |
M |
262.2 |
277.1 |
14.9 |
286.5 |
24.3 |
|||
Rm4750 |
M |
255.8 |
272.7 |
16.9 |
281.8 |
26.0 |
|||
F : Female M: Male
*: Calculated based on the density of the test item: 1.05 g/cm3(as per TIDS provided by the sponsor), i.e., 1.90 mL/kg (dose volume as per density) x 2.38 (correction factor).
Table 2. Individual Clinical / Toxic Signs and Necropsy Findings
Rat No. |
Sex |
Body weight initial (g) |
Volume applied (mL)
|
Day of Observations |
|||||||||||
Day 1 |
2 |
3 |
4 |
5 |
6 |
7 |
|||||||||
1 hour |
2 hours |
3 hours |
4 hours |
|
|
|
|
|
|
||||||
AM |
PM |
AM |
PM |
||||||||||||
Rm4741 |
F |
222.4 |
1.01 |
N |
N |
N |
N |
N |
N |
124(4) |
124(4) |
124(1) |
124(2) |
124(2) |
N |
Rm4742 |
F |
229.2 |
1.04 |
N |
N |
N |
N |
N |
N |
124(4) |
124(4) |
124(1) |
124(1) |
124(2) |
124(2) |
Rm4743 |
F |
224.6 |
1.02 |
N |
N |
N |
N |
N |
N |
124(4) 124(5) |
124(4) 124(5) |
124(4) |
124(1) |
124(1) |
124(2) |
Rm4744 |
F |
211.6 |
0.96 |
N |
N |
N |
N |
N |
N |
124(4) 124(5) |
124(4) 124(5) |
124(4) |
124(1) |
124(1) |
124(2) |
Rm4745 |
F |
218.2 |
0.99 |
N |
N |
N |
N |
N |
N |
124(4) |
124(4) |
124(1) |
124(2) |
124(2) |
N |
Rm4746 |
M |
235.8 |
1.07 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Rm4747 |
M |
240.3 |
1.09 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Rm4748 |
M |
266.8 |
1.21 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Rm4749 |
M |
262.2 |
1.19 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Rm4750 |
M |
255.8 |
1.16 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
F: Female M: Male NAD: No Abnormality Detected N: AM: Ante Meridian PM: Post
124(1): Scale formation 124(2): peeling / desquamation 124(4): Erythema 124(5): Edema
*: Calculated based on the density of the test item: 1.05 g/cm3(as per TIDS provided by the sponsor), i.e., 1.90 mL/kg (dose volume as per density) x 2.38 (correction factor).
Table 2 contd. Individual Clinical / Toxic Signs and Necropsy Findings
Group: G1 Dose: 2000 mg/kg body weight (4.52 mL/kg *)
Rat No. |
Sex |
Body weight initial (g) |
Volume applied (mL)
|
Days of observation | Necropsy Findings |
|
|||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|
|||||
|
|
|
|
|
|
|
|
||||||
Rm4741 |
F |
222.4 |
1.01 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4742 |
F |
229.2 |
1.04 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4743 |
F |
224.6 |
1.02 |
124(2) |
124(2) |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4744 |
F |
211.6 |
0.96 |
124(2) |
124(2) |
124(2) |
N |
N |
N |
N |
N |
NAD |
|
Rm4745 |
F |
218.2 |
0.99 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4746 |
M |
235.8 |
1.07 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4747 |
M |
240.3 |
1.09 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4748 |
M |
266.8 |
1.21 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4749 |
M |
262.2 |
1.19 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm4750 |
M |
255.8 |
1.16 |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
F: Female M: Male NAD: No Abnormality Detected N: AM: Ante
PM: Post Meridian 124(1): Scale formation 124(2): peeling/desquamation 124(4): Erythema 124(5): Edema
*: Calculated based on the density of the test item: 1.05 g/cm3(as per TIDS provided by the sponsor), i.e., 1.90 mL/kg (dose volume as per density) x
2.38 (correction factor).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, the LD50 of the registration substance is determined to be higher than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the registration substance was investigated according to the OECD Gudieline 402. Five female and five male rats were treated once with the registration substance at dose of 2000 mg/kg bw. No effect was observed. The LD50 of the registration substance was determined to be higher than 2000 mg/kg bw. No classification is warranted.
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