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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-08-03 to 1981-08-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Only a brief summary of the study is available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate
EC Number:
220-189-5
EC Name:
Sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate
Cas Number:
2657-00-3
Molecular formula:
C10H6N2O4S.Na
IUPAC Name:
sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate
Test material form:
solid
Specific details on test material used for the study:
not further specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Source: Hoechst AG, Frankfurt, Germany
-Females (if applicable) nulliparous and non-pregnant: yes
-Weight at study initiation: 180 - 198 g
-Fasting period before study: 16 hours before until up to 2 hours after treatment
-Housing: groupwise
-Diet: ad libitum
-Water: ad libitum

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
-Concentration in vehicle: 250 g/L
-Dosing volume: no data
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 f
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
-Frequency of observations: daily
-Frequency of weighing: weekly
-Necropsy of survivors performed: yes
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All rats survived the observation period
Clinical signs:
No signs of toxicity were seen in dosed rats
Body weight:
The body weight development of the rats was inconspicuous during the study
Gross pathology:
The gross pathological examination revealed no organ alterations

Any other information on results incl. tables

Study design

In this study performed equivalent to OECD GL 401 the test item was tested for acute toxicity in female rats after single oral administration of 5000 mg/kg body weight.

Results

No signs of toxicity and no deaths during the course of the study were seen in dosed rats. The body weight development of the rats was inconspicuous during the study and the gross pathological examination revealed no organ alterations.

Conclusion

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in female rats.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in female rats.
Executive summary:

Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in female rats.