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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
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
274-675-7
EC Name:
Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
70571-81-2
Molecular formula:
C22H17N3O6S.Na
IUPAC Name:
sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 9 week, females: 14 weeks
- Weight at study initiation: males: 151 to 167 g; females: 156 to 177 g
- Fasting period before study: yes - 16 hours before to 4 hours after dosing
- Housing: groups of 5 rats/sex
- Diet (e.g. ad libitum): Altromin R 1324 ad lib
- Water (e.g. ad libitum): tap water ad lib
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: July/August 1982

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: water soluble substance
- Lot/batch no. (if required): -
- Purity: -

Doses:
5000 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: observations on treatment day: multiple times, thereafter twice daily on week days, once daily on week-ends
weighing: Day 1, 7, 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no effect
Gross pathology:
no abnormalities

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No deaths or adverse effects were observed in male and female rats at a dose level of 5000 mg/kg bw. Hence the LD0 and Ld50 is above 5000 mg/kg bw.