Sodium 3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulphonate

Endpoint summary

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

Reference

Reference 1

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

02-1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 or test system 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.

Reference 2

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 for cross-reference:

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

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.