Registration Dossier
Registration Dossier
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EC number: 947-349-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity of the registration substance was investigated according to the OECD Gudieline 423. Six female 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.
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.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24/05/2016 - 18/07/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- 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.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- 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: 189.4 to 209.2 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 to seven days 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 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The dose level of 2000 mg/kg refers to the active ingredient, the registration substance
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:2000 mg/kg
DOSAGE PREPARATION : The undiluted test item as supplied by the sponsor was administered based on the density of the test item i.e., 1.05 g/cm3 at 20 ºC (as per TIDS provided by the sponsor) and the dose volume was 4.52 mL/kg body weight, i.e., [1.90 (dose volume as per density) x 2.38 (correction factor)] to attain the dose of 2000 mg/kg body weight (G1-FTS) as oral gavage to overnight fasted (16 to 18 hours) 3 female rats.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As per the Material Safety Data Sheet provided by the Sponsor, the acute oral LD50 rat is > 2000 mg/kg body weight. Hence the test was started as per Annex 2d of the OECD 423 test guideline. The starting dose was 2000 mg/kg body weight (G1-FTS). No test item-related mortality was observed; hence test was continued with same dose with three additional female rats second step (G1-STS). The subsequent dosing was done at approximately 48 hours after the first dosing- Doses:
- Doses: 2000 mg/kg body weight (first treatment step and second treatment step)
- No. of animals per sex per dose:
- 3 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration. The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology. - Preliminary study:
- Body weights, body weight changes and pre-terminal deaths are presented in Table 1.
Individual clinical signs and necropsy findings are presented in Table 2. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- No abnormality detected at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of the registration substance was investigated according to the OECD Gudieline 423. Six female 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.
- Executive summary:
The acute oral toxicity of the registration substance was investigated according to the OECD Gudieline 423. Six female 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One valid recently performed study available.
Acute toxicity: via dermal route
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- 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.
- 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- 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. - 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. - 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.
- 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.
Reference
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).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One valid recently performed study available.
Additional information
Justification for classification or non-classification
No classification is warranted for the endpoints acute toxicity based on the results obtained in the oral acute toxicity study (OECD 423) and dermal acute toxicity study (OECD 402).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
