Registration Dossier

Administrative data

Description of key information

RA OECD 401: LD50 (rat,oral) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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
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
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
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
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.
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

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.

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.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 401. A detailed read across justification is provided in chapter 13 of this dossier.
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
other: common degradation product
Remarks on result:
other: Read Across
Interpretation of results:
GHS criteria not met
Conclusions:
For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 401. The oral LD50 in rats was larger than 2000 mg/kg bw. See chapter 13 report for a more detailed justification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
According to OECD Guideline and GLP conform.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.