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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
EC Number:
283-044-5
EC Name:
Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
Cas Number:
84539-55-9
Molecular formula:
non specified (UVCB substance)
IUPAC Name:
Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts
Details on test material:
- Lot/batch No.: FRH 5271 AG
- Storage condition of test material: room temperature in the dark
- Analytical purity: 100 % (UVCB)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Concentration in vehicle: 100 mg/ml
- Maximum dose volume applied: 2 ml/100g bodyweight
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
no signs of systemic toxicity
Body weight:
expected gain in bodyweight during the study except for one male which showed a reduced gain in bodyweight during the second week
Gross pathology:
no abnormalities were noted at necropsy

Applicant's summary and conclusion

Conclusions:
The acute oral median LD50 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.