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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-07-15 to 2015-08-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bioassay, Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of Disodium (sulphonatothio)acetate and sodium chloride
EC Number:
947-115-0
Molecular formula:
C2H2Na2O5S2.NaCl
IUPAC Name:
Reaction mass of Disodium (sulphonatothio)acetate and sodium chloride
Test material form:
liquid
Details on test material:
Purity of Test material:
60.9 % Disodium (sulphonatothio)acetate
20.3 % NaCl
4.3 % Na2S2O3
0.6 % NasSO4
5.0 % H2O
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Sample 14/078 from Mollescal HW, charge 10924344R0
- Expiration date of the lot/batch: April 28, 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany<
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation:
- Fasting period before study: at least 16 hours
- Housing: Single housing (Makrolon cage, type III)
- Diet: ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 and 3 g/100mL
- Amount of vehicle: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 300 mg/kg bw was chosen in the first step with 3 female animals.
Doses:
50, 300 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: shortly before administration (day 0), weekly thereafter and on the day of death or sacrifice moribund starting with study day 1.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Mortality:
In the 300 mg/kg bw test group all animals were found dead on study day 1 after administration. No mortality occurred in both 50 mg/kg bw test groups.
Clinical signs:
Impaired general state and piloerection was noted at hour 5 in all animals of the high dose group. Cowering position was additionally observed in two of these animals at the same time point.
Impaired general state and piloerection was also noted in all animals of the first 50 mg/kg bw group from hour 2 to 4 after administration.
The animals of the second 50 mg/kg bw group did not show any clinical signs at examination.
Body weight:
The body weights of the surviving animals increased within the normal range throughout the study period with two exceptions. In two females of the first 50 mg/kg bw test group the body weight increased in a normal range during the first observation week. In the second week, the body weight stagnated in one animal while in the other animal marginal body weight loss was noted.
All three animals of the 300mg/kg bw. test group, which were found dead on study day 1, revealed a loss of body weight.
Gross pathology:
The following macroscopic pathologic findings were observed in all animals of the 300 mg/kg bw test group which were found dead on study day 1:
Dark red, spotted discoloration of all lung lobes, red discoloration of the small intestine contents and light spotted discoloration of the liver.
There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (50 mg/kg bw, 6 females).

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria