Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 618-233-7 | CAS number: 890707-28-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 2020 to 30 May 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- October 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-amino-5-chloro-N,3-dimethylbenzamide
- Cas Number:
- 890707-28-5
- Molecular formula:
- C9H11ClN2O
- IUPAC Name:
- 2-amino-5-chloro-N,3-dimethylbenzamide
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan: WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat (Rattus norvegicus)
Strain: RccHan: WIST
Age/Weight at Dosing: 10 to 12 weeks, Weight (g) Minimum: 205.7, Maximum: 229.4
Source: Animal Breeding Facility, Jai Research Foundation
Total Number of Animals Used: Six females (nulliparous and non-pregnant)
Acclimatisation: 6 to 17 days
Animal Identification: Each rat was uniquely numbered on the tail using a tattoo machine on day 1 of acclimatisation. Appropriate labels were attached to the cages indicating the study number, test item code, group number, sex, dose, type of study, cage number and animal number.
Caging: Polypropylene rat cages covered with stainless-steel grid top were used. Autoclaved clean rice husk was used as the bedding material. Wooden blocks were provided as enrichment material.
Water Bottle: Each cage was supplied with a polypropylene water bottle with a stainless-steel nozzle.
Housing: Maximum of three rats per cage, Room No. BMR 28
Room Sanitation. daily:
1. Rack was cleaned with cloth,
2. Floor of experimental procedure room was swept,
3. All work tops and the floor were mopped with a disinfectant solution (Dettol 2.5%).
Feed and Water
The rats were provided with feed and water, ad libitum. The quality of feed and water is regularly monitored at Jai Research Foundation. There were no known contaminants in the feed and water at levels that would have interfered with the experimental results obtained.
Feed: Teklad certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
Water: UV sterilised water filtered through Reverse Osmosis water filtration system.
Environmental Conditions
Animal Room: BMR 28, Department of Toxicology
Temperature: 20 to 23°C
Relative Humidity: 56 to 66%
Air Changes: Minimum 15 air changes/hour
Photoperiod : The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h–18:00 h (photoperiod was maintained through automatic timer)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Individual dose volume was adjusted according to body weight and dose level (10 mL/kg body weight):
Dose: 175 mg/kg = Dose Volume administered: 2.06–2.25 mL; Dose: 550 mg/kg = Dose Volume administered: 2.17–2.29 mL
- Amount of vehicle: a constant volume of 10 mL/kg body weight
ORAL GAVAGE
- All rats were dosed by oral gavage (day 0) using a metal cannula attached to a BD 1 mL disposable syringe, which was graduated up to 1 mL. Rats were fasted overnight, prior to dosing, until three hours post-dosing. - Doses:
- Dose: 175 mg/kg = Dose Volume administered: 2.06–2.25 mL;
Dose: 550 mg/kg = Dose Volume administered: 2.17–2.29 mL - No. of animals per sex per dose:
- three animals/female/Dose: 175 mg/kg
three animals/female/Dose: 550 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At 0.5, 1, 2, 3, 4 and 5 h post-administration on the day of dosing.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: The clinical signs were recorded at least once a day. Individual body weight was recorded prior to dosing on day 0, and on days 7 and 14 and at death.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 310.2 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 175 - <= 550
- Mortality:
- Mortality was observed in rats treated at 550 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight (rat Nº 2, 4, and 6), while, no mortality was observed in rats treated at 175 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight (rat N˚ 1, 3, and 5).
- Clinical signs:
- other: Clinical sign (lethargy) was observed in rats treated at 550 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight (rat Nº 2, 4, and 6), while no clinical sign was observed in rats treated at 175 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight
- Gross pathology:
- External Examination:
An external examination of the found dead and terminally sacrificed rats did not reveal any abnormality.
Internal Examination:
An internal examination of the found dead and terminally sacrificed rats did not reveal any lesion.
Any other information on results incl. tables
Dose, Mortality/Rats Treated:
Dose (mg/kg body weight) |
Female rats (mortality/total) |
175 |
0/3 |
550 |
3/3 |
Test Sequence and Mortalities:
Rat N° |
Dose (mg/kg body weight) |
Mortality after Dosing |
|||||
½ - 5 h |
24 h |
48 h |
72 h |
4 – 7 Day |
8 – 14 Day |
||
1 |
175 |
O |
O |
O |
O |
O |
O |
2 |
550 |
O |
O |
X |
- |
- |
- |
3 |
175 |
O |
O |
O |
O |
O |
O |
4 |
550 |
O |
X |
- |
- |
- |
- |
5 |
175 |
O |
O |
O |
O |
O |
O |
6 |
550 |
O |
O |
O |
X |
- |
- |
Note: O = Survived, X = Dead, - = Not applicable.
Individual Clinical Observations:
Rat N° |
Dose (mg/kg body weight) |
Clinical Signs Observed after Dosing |
|||||||||||||||||||
At Hour (Day 0) |
On Day |
||||||||||||||||||||
0.5 |
1 |
2 |
3 |
4 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
175 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
550 |
1 |
1 |
1 |
1 |
11 |
11 |
11 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3 |
175 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
4 |
550 |
1 |
1 |
1 |
1 |
11 |
11 |
11, 2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5 |
175 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
6 |
550 |
1 |
1 |
11 |
11 |
11 |
11 |
11 |
11 |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Note: Day 0 = Day of dosing, - = Not applicable.
Clinical Sign: 1 = Normal, 2 = Dead, 11= Lethargy.
Individual Necropsy Findings:
Rat N° |
Dose (mg/kg body weight) |
Mode of Death |
External |
Internal |
1 |
175 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
2 |
550 |
Found dead |
No abnormality detected |
No abnormality detected |
3 |
175 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
4 |
550 |
Found dead |
No abnormality detected |
No abnormality detected |
5 |
175 |
Terminal sacrifice |
No abnormality detected |
No abnormality detected |
6 |
550 |
Found dead |
No abnormality detected |
No abnormality detected |
Interpretation of Results
The LD50 was calculated as per the Dixon’s maximum likelihood method using software (AOT 425 StatPgm) and found to be 310.2 mg/kg body weight in female Wistar rats with 95% confidence interval is 175 to 550 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on results of this study, the acute oral median lethal dose for 2-amino-5-chloro-N,3-dimethylbenzamide in Wistar rats was found to be 310.2 mg/kg body weight in female Wistar rats with 95% confidence interval is 175 to 550 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study in female Wistar rats (10 to 12 weeks old), the toxicological profile of 2-amino-5-chloro-N,3-dimethylbenzamide was assessed and the median lethal dose determined. A single oral dose of 2-amino-5-chloro-N,3-dimethylbenzamide was administered orally to fasted rats (formulated using corn oil as a vehicle and at a constant dose volume of 10 mL/kg) through gavage. Initially rat N° 1 was tested with a starting dose-level of 175 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight. The tested rat survived at this dose level, subsequently five additional female Wistar rats received dose of 550 mg (rat N˚ 2, 4 and 6) and 175 mg (rat N˚ 3 and 5) 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight, according to the Up and Down Procedure. All surviving rats were observed for 14 days.
Mortality was observed in rats treated at 550 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight while no mortality was observed in rats treated at 175 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight.
Clinical sign (lethargy) was observed in rats treated at 550 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight, while no clinical sign was observed in rats treated at 175 mg 2-amino-5-chloro-N,3-dimethylbenzamide/kg body weight.
A normal gain in the body weight was observed in surviving rat.
The number of animals which died or showed evident toxicity is shown below:
Dose
(mg/kg bw)Mortality
(# dead/total)Time range of deaths (h)
Evident toxicity
(#/total)175
0/3
-
0/3
550
3/3
24 to 72
3/3
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)