3,4-diaminobenzenesulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP-Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4-diaminobenzenesulphonic acid

EC Number:

231-274-1

EC Name:

3,4-diaminobenzenesulphonic acid

Cas Number:

7474-78-4

Molecular formula:

C6H8N2O3S

IUPAC Name:

3,4-diaminobenzene-1-sulfonic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Number of animals: 3 per step
Age at the beginning of the study: 10 - 11 weeks old
Body weight
on the day of administration: Step 1 / animals no. 1 - 3: 169 – 186 g
Step 2 / animals no. 4 - 6: 166 – 184 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
- Full barrier in an air-conditioned room
- Temperature: 22 3 °C
- Relative humidity: 55 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0815)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Aqua ad injectionem (sterile water, AlleMan Pharma, lot no. 110147, expiry date: 02/2014)
This vehicle was chosen due to its non-toxic characteristics
In order to get the test item in a solution or suspension, which is applicable to the animals, aqua ad injectionem (sterile water) was evaluated as vehicle and was considered to be adequate.
The test item was weighed out into a tared plastic vial on a precision balance.
Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before every dose administration.
For all animals of both steps, 1 g of the test item were suspended in the vehicle to gain a final volume of 25 mL and to achieve a dose of 400 mg/kg body weight at a dose volume of 10 mL/kg body weight. These dose formulations were applied five times to the animals to achieve a final dose of 2000 mg/kg body weight. The dose formulations were made shortly before each dosing occasion

Doses:

The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.

No. of animals per sex per dose:

3

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

The test item showed no acute oral toxicity characteristics after administration of 2000 mg/kg bw within eight hours.

Clinical signs:

other: No clinical signs were observed at any animal.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, a single oral application of the test item 3,4-Diaminobenzensulfonic acid to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of 3,4-Diaminobenzensulfonic acid after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC [7] the test item 3,4-Diaminobenzensulfonic acid has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 [8] the test item 3,4-Diaminobenzensulfonic acid has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) [9] the test item 3,4-Diaminobenzensulfonic acid has no obligatory labelling requirement for toxicity and is not classified.