Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 - 29 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Adopted: 17th December 2001
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Slovenska Narodna Akreditacna Sluzba (SNAS), Bratislava, Slovenska republika
Test type:
acute toxic class method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
Disodium 4,5-dihydroxybenzene-1,3-disulphonate
EC Number:
205-741-5
EC Name:
Disodium 4,5-dihydroxybenzene-1,3-disulphonate
Cas Number:
149-45-1
Molecular formula:
C6H6O8S2.2Na
IUPAC Name:
disodium 4,5-dihydroxybenzene-1,3-disulphonate

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Slovak Academy of Sciences Dobrá Voda, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 185 - 197 g
- Fasting period before study: overnight
- Housing: 3 animals per cage in plastic cages suspended on stainless steel racks
- Diet: Ssniff, ad libitum
- Water: tap water, ad libitum (3-4 h after administration)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.61 ± 0.57
- Humidity (%): 54.39 ± 2.72
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: a standard vehicle according to OECD TG 423
- Lot/batch no.: 0219M17, Imuna Pharm a.s., Slovakia


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Step 1: 3
Step 2: 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 h later. Each animal was inspected daily for the next 14 days. Individual weights of animals were measured immediately prior to administration of the test item and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Animals sacrificed at the end of the post-treatment observation period showed no evidence of test-substance related grossly visible organ lesions.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.