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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.