Registration Dossier

Diss Factsheets

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: Only short summary available. Procedure follows OECD testing guideline as far as can be derived from results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
limited reporting details on results
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
EC Number:
227-877-4
EC Name:
Disodium 4,4'-diamino-9,9',10,10'-tetrahydro-9,9',10,10'-tetraoxo[1,1'-bianthracene]-3,3'-disulphonate
Cas Number:
6022-22-6
Molecular formula:
C28H16N2O10S2.2Na
IUPAC Name:
disodium 4,4'-diamino-9,9',10,10'-tetraoxo-9,9',10,10'-tetrahydro-1,1'-bianthracene-3,3'-disulfonate
Details on test material:
- Purity: 82.9 %
- Lot/batch No.: EN 901700.99

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
young adult albino rats were used. No further details available.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None given
Doses:
200 and 2000 mg/kg
No. of animals per sex per dose:
- 200 mg/kg: 3 female animals;
- 2000 mg/kg: 3 female animals; 3 male animals;
Control animals:
no
Details on study design:
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute toxicity testing. The animals recovered within 3 to 5 days.
Mortality:
No mortality observed.
Clinical signs:
other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute toxicity testing. The animals recovered within 3 to 5 days.
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information