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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles (non-GLP) For read-across justification refer to section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Principles of method if other than guideline:
BASF-TEST: In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Several groups of 10 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight was determined before the start of the study as well as after day 2, 5, 7 and 13.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium ethylenediaminetetraacetate
EC Number:
200-573-9
EC Name:
Tetrasodium ethylenediaminetetraacetate
Cas Number:
64-02-8
Molecular formula:
C10H16N2O8.4Na
IUPAC Name:
tetrasodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Details on test material:
- Lot/batch No.: 03370
- Purity: 75%
- Impurities (identity and concentrations): 8% Na3 Ethylenediaminetriacetic acid, 1.2% Na2 Ethylenediaminetriacetic acid, 3.6% Na3 Nitriloltriacetic acid, < 0.3% Na2 iminodiacetic acid, 2.6% Na-glycolic acid, urotropin
- Expiration date of the lot/batch: April 1984
- Physical state: solid powder
- Molecular formula (if other than submission substance): C10 H12 N2 O8 Na4
- Molecular weight (if other than submission substance): 380.17
- Smiles notation (if other than submission substance): [Na]OC(=O)CN(CCN(CC(O[Na])=O)CC(O[Na])=O)CC(O[Na])=O
- InChl (if other than submission substance): InChI=1S/C10H16N2O8.4Na/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19) 20;;;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;;;/q;4*+1/p-4
- Structural formula attached as image file (if other than submission substance): see Fig. 64-02-8 Structure.png

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GmbH, Biberach, Germany
- Weight at study initiation:
1210 mg/kg bw: 179 g males/178 g females
1780 mg/kg bw: 188 g males/180 g females
2000 mg/kg bw: 180 g males/182 g females
2610 mg/kg bw: 188 g males/187g females
- Housing: 5 animals per cage
- Diet: Ssniff R ad libitum):
- Water: ad libitum
- Acclimation period: at least one week
- Fasting period before study: 16 h

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
DOSAGE PREPARATION
- Stock solutions prepared:
12.1% for the 1210 mg/kg bw dose group
17.8% for the 1780 mg/kg bw dose group
20.0% for the 2000 mg/kg bw dose group
26.1% for the 2610 mg/kg bw dose group

DOSE VOLUME APPLIED:
10 ml/kg bw
Doses:
1210 mg/kg bw; 1780 mg/kg bw; 2000 mg/kg bw; 2610 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: prior to the start of the experiment and on day 2, 5, 7, 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 913 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
1 780 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 780 - < 2 000 mg/kg bw
Mortality:
No mortalities were observed in the lowest dose group. At 2000 mg/kg bw all females and 7/10 males died (see table 1). In the highest dose group still half of the males survived.
Clinical signs:
other: 1210 mg/kg bw: no effects 1780 mg/kg bw: males dyspnea, apathy, ataxia, shaggy fur, poor general state; fully reversible within 5 days /females dyspnea, apathy, ataxia, abnormal positions, spastic gait, exiccosis, diarrhea, shaggy fur, saliva, poor genera
Gross pathology:
Animals that died:
stomach: redness and/or bloody ulceration of the glandular part of the stomach, redness of the mucous membrane, general hyperemia
gut: atonic, redness of the mucous membrane, bloody mucous content, general hyperemia

Animals which were sacrificed:
nothing abnormal detected

Any other information on results incl. tables

Table 1: Mortalities of rats after oral application of Na4EDTA

1210 mg/kg bw 1780 mg/kg bw 2000 mg/kg bw  2610 mg/kg bw
1 h male  0/10 0/10 3/10 0/10
female 0/10 0/10 1/10 6/10
24 h male  0/10 2/10 7/10 5/10
female 0/10 4/10 10/10 10/10
48 h male  0/10 2/10 7/10 5/10
female 0/10 4/10 10/10 10/10
7 d male  0/10 2/10 7/10 5/10
female 0/10 4/10 10/10 10/10
14 d male  0/10 2/10 7/10 5/10
female 0/10 4/10 10/10 10/10

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The observed acute oral toxicity indicates that the substance should be classified with acute toxicity category 4 according to CLP/GHS criteria.
Executive summary:

The observed acute oral toxicity indicates that the substance should be classified with acute toxicity category 4 according to CLP/GHS criteria.