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EC number: 220-290-4 | CAS number: 2702-72-9
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation, Human and Domestic Animals, Series 81, 82, and 83, US Department of Commerce, National Technical Information Service PB91-154617, 1991.
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- EC Number:
- 217-915-8
- EC Name:
- Dimethylammonium 2,4-dichlorophenoxyacetate
- Cas Number:
- 2008-39-1
- IUPAC Name:
- N-methylmethanaminium (2,4-dichlorophenoxy)acetate
- Details on test material:
- - Name of test material (as cited in study report): 2,4-D DMA
- Analytical purity: 66.2% active ingredient in aqueous based manufacturing concentrate
- Source of test material: Industrial Task Force on 2,4-D Research Data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA
- Age at study initiation: 5 - 7.5 months
- Housing: individually in cages with wire floors
- Diet: certified Laboratory rabbit chow No. 5322 (Purina Mills, Inc. St. Louis, MO)
- Water: municipal water ad libitum
- Acclimation period: at least two weeks
ENVIRONMENTAL CONDITIONS
The animal rooms of the facility were designed to maintain environmental conditions with respect to temperature, relative humidity, airflow
and lightning conditions, and were regulated for rabbits.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Not specified if vehicle is corn oil, sterile deionized water or aqueous methylcellulose
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1 - 10 mL/kg body weight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of the test substance in the dosing solution was confirmed by validated analytical methods (HPLC of GC)
- Details on mating procedure:
- - Impregnation procedure: artificial insemination, day of insemination is considered day 0 of gestation
- Any other deviations from standard protocol:
After insemination, rabbits were given an intravenous injection of 20 - 100 international units of human chorionic gonadotropin. - Duration of treatment / exposure:
- Gestation days 6 - 18
- Frequency of treatment:
- once daily
- Duration of test:
- 29 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
12, 36.1 and 108.4 mg/kg bw/day
Basis:
nominal conc.
active ingredient
- Remarks:
- Doses / Concentrations:
10, 30 and 90 mg/kg bw/day
Basis:
other: 2,4-D acid equivalent
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: all animals were observed twice daily for signs of treatment related effects
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded on GD 0, either daily or every third day during the dosing period, and on days 20, 24, 28 and/or 29 of gestation
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 28 or 29
- post-mortem examinations were also performed on all females who died spontaneously or were sacrificed in a moribund condition. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes (including their positions)
- Number of resorptions: Yes
Other:
- live and dead fetuses were counted
- Uteri with no visible implantations were stained with a 10% solution of ammonium sulphide, and examined for evidence of early resorptions. - Fetal examinations:
- - External examinations: Yes
- Skeletal examinations: Yes
- Each fetus was individually identified, weighed, sexed, and given a gross examination for external malformations/variations to include observation for palatal defects.
- All fetuses were euthanized and examined by dissection for evidence of visceral alterations. This also included a fresh examination of the brain.
All fetuses were then preserved in alcohol, eviscerated, cleared and stained with alizarin red-S and examined for skeletal alterations. - Statistics:
- Different statistical tests were used (e.g. Bartlett, Anova, Wilcoxon) to analyse maternal body weight, maternal body weight gain, gravid uterine weight, feed consumption, litter averages for percent male fetuses, fetal body weights, number of fetuses, litter size, number of corpora lutea, number of implantations, fetal ossification sites, and percent fetal alterations.
- Historical control data:
- Data was compared to historical control data, but these data were not explicitly given.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Dose-related clinical signs of toxicity were seen at or above a dose of 36.1 mg/kg bw/day (30 mg/kg bw/day acid equivalent). With higher acid equivalent doses (90 mg/kg/day), more severe maternal effects were noted. Clinical signs of toxicity (myotonia, ataxia, and impaired/lost righting reflex) became evident. The lack of effect on maternal body weight gain may be explained with the low increase observed with the control group. The body weight gain throughout the observation time was only half in comparison to the other controls of experiments conducted in parallel.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 36.1 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 108.44 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no effects on maternal reproductive parameters observed (litter size, resorption rates, etc.) or on fetal body weights. No evidence of teratogenicity was observed. Low incidences of malformations were seen scattered through the different dose groups, including control. The incidences of the individual malformations observed were consistent with historical control data.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: 2,4-D DMA Teratology: maternal, reproductive and fetal parameters in rabbits
|
DMA - Dose (mg/kg/day) |
|||
0 |
12 |
36.1 |
108.44 |
|
2,4-D equivalent (mg/kg/day) |
0 |
10 |
30 |
90 |
Maternal parameters |
|
|
|
|
No. bred |
20 |
20 |
20 |
20 |
No. deaths |
0 |
0 |
4 |
0 |
Sacrificed |
0 |
0 |
0 |
0 |
Aborted |
0 |
1 |
1 |
0 |
Maternal body weight gain (GD 6 – 19) (kg) |
0.10 |
0.10 |
0.12 |
0.14 |
Reproductive parameters |
|
|
|
|
No. Litter |
20 |
16 |
18 |
14 |
No. of implantations |
177 |
133 |
163 |
112 |
% implantations resorbed |
4.0 |
5.3 |
4.9 |
11.6 |
% Litters with resorptions |
30.0 |
43.8 |
33.3 |
57.1 |
Fetal body weight (g) |
43.6 ± 5.6 |
42.9 ± 7.1 |
40.9 ± 5.9 |
44.5 ± 7.0 |
Fetal parameters |
|
|
|
|
Fetuses examined* |
170 (20) |
126 (16) |
155 (18) |
99 (14) |
Visceral alterations |
|
|
|
|
- Lung lobe, agenesis* |
3 (3) |
2 (1) |
1 (1) |
0 |
Skeletal alterations |
|
|
|
|
- Ribs. 7th cervical |
0 |
0 |
0 |
0 |
Total external malformations |
0 |
0 |
1 (1) |
1 (1) |
Total visceral malformations |
3 (3) |
2 (1) |
1 (1) |
1 (1) |
Total skeletal malformations |
2 (2) |
2 (1) |
2 (2) |
5 (5) |
Study was performed at Argus Laboratories
* - No. of fetuses (No. of litters)
** - considered a malformation
Maternal toxicity was noted at or above a dose level of 36.1 mg/kg bw/day (30 mg/kg bw/day acid equivalent). At these dose levels, embryonal and fetal development was essentially unaffected, and there was no indication of any teratogenic effect. Therefore the test substance is not considered to be teratogenic under the conditions of this test.
Applicant's summary and conclusion
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.
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