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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-10-02 to 1990-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[ethylenebis(oxy)]bisacetic acid
EC Number:
245-516-9
EC Name:
2,2'-[ethylenebis(oxy)]bisacetic acid
Cas Number:
23243-68-7
Molecular formula:
C6H10O6
IUPAC Name:
2-[2-(carboxymethoxy)ethoxy]acetic acid
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: D 271
- Expiration date of the lot/batch: 16.07.1991

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 20 °C in fume cupboard
- Stability under test conditions: stable


Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 163 - 175 g (males); 177 - 185 g (females)
- Age at study initiation: males appr: 7 weeks, females appr. 8 weeks
- Fasting period before study: 16 hours before application
- Housing: in groups of 5 in macrolon cages
- Diet: ad libitum (Altromin 1324)
- Water: ad libitum (tap water)
- Acclimation period: not necessary as breeding under identical conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test item was diluted in water (with a magnetic stirrer) to a concentration of 20 % (w/v).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopically examinations
Statistics:
not necessary

Results and discussion

Preliminary study:
No details on preliminary study.
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One male animal died during the 14 days-observation period.
Clinical signs:
Reduced sponataneous activity, hunched posture, ruffled fur, tumbling gait, irregular breathing and respiratory sounds were noticed after administration.
Body weight:
One female animal exhibited a reduced body weight gain. The other animals exhibited a normal weight gain.
Gross pathology:
No macroscopically visible changes were found in the animals sacrificed at termination. The male animal that died during the observation period exhibited darkened liver, autolysis and its intestinal tract was filled with blood.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of the test item was determined to be > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1. Five wistar rats of each sex were exposed to the test item by oral gavage at a limit dose of 2000 mg/kg bw. The animals were observed for 14 days. One male animal died during the observation period. The body weights were not affected except for one female rat exhibiting reduced body weight gain. No macroscopic changes were noticed at necropsy, the animal that had died during the observation period exhibited a darkened liver together with auolysis and a blood-filled intestinal tract. The LD50 of the test item was determined to be >2000 mg/kg bw.