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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:
1988-04-12 to 1988-04-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
02-1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Designation: Farbstoff-F-chlorid stab.
Product Code: RWGAAA05
Chemical name: 3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulfonyl chloride
Specification: yellow powder
Purity: 67 %
Batch: Op. 4/88 dated 1988-01-19

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Hoechst AG, Kastengrund, Germany
-Females (if applicable) nulliparous and non-pregnant: yes
-Age at study initiation: 7 - 8 weeks
-Weight at study initiation: 173 - 203 g
-Fasting period before study: 16 hours before until up to 4 hours after treatment
-Housing: groupwise in Makrolon cages
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 3
-Humidity (%): 50 +/- 20
-Photoperiod (hrs dark / hrs light): 12 / 12

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: 20 % (w/v)
-Dosing volume: 10 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 m / 5 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:
Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 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:
High position, retracted flanks, irregular breathing, rough fur
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 GLP study performed according to the OECD GL 401, the test item was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight.

Results

Apart from high position, retracted flanks, irregular breathing, and rough fur after dosing no further signs of toxicity were seen and no deaths during the course of the study. 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 2000 mg/kg after single oral administration in 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 2000 mg/kg after single oral administration in rats.
Executive summary:

This study was performed according to GLP and is fully compliant OECD GL 401. 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 2000 mg/kg after single oral administration in rats.