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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
OECD n° 423 (24 April 2002)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Test method B.1tris directive 2004/73/EC
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
powder
Details on test material:
- Name of test material (as cited in study report) : 1-(2-Hydroxy-3-sulfopropyl)-pyridinium-betain
- Physical state : white powder
- Storage condition of test material : room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source : Elevage JANVIER (53940 Le Genest St Isle –France)
- Age at study initiation : 8 weeks
- Weight at study initiation : 186g - 206g
- Fasting period before study : no
- Housing : Three rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet (e.g. ad libitum): M20-rat/mouse maintenance diet , ad libitum (Food was removed at D-1 and then redistributed 4 hours after the test item administration.)
- Water (e.g. ad libitum) : Drinking water, ad libitum (tap-water from public distribution system)
- Acclimation period : at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature : 20°C - 23°C
- Humidity : 32% - 60%
- Air changes (per hr) : not stated
- Photoperiod (hrs dark / hrs light) : 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
The animals of treated group, received an effective dose of 2000 mg/kg body weight of the test item, diluted in distilled water and administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing : on day D0 (just before administering the test item) then on D2, D7, and D14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopical examination

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The study was performed according to the OECD guideline No. 423 dated 17 December 2001 concerning acute oral toxicity and the test method B.1 tris of the Directive No. 2004/73/EC with no deviations and according to the good laboratory practice principles. It is considered to be of the highest quality (reliability Klimisch 1). The test item 1-(2-Hydroxy-3-sulfopropyl)-pyridinium-betain was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight.
The LD50 of the test item 1-(2-Hydroxy-3-sulfopropyl)-pyridinium-betain is higher than 5000 mg/kg body weight by oral route in the rat, in accordance with Annex 2d of the OECD guideline 423.
Executive summary:

The test item 1-(2-Hydroxy-3-sulfopropyl)-pyridinium-betain was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated December 17th, 2001 and the test method B.1tris of the Directive N° 2004/73/EC.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item 1-(2-Hydroxy-3-sulfopropyl)-pyridinium-betain is higher than 5000 mg/kg body weight by oral route in the rat, in accordance with Annex 2d of the OECD guideline n°423.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item 1-(2- Hydroxy-3-sulfopropyl)-pyridinium-betain must not be classified. No symbol and risk phrase are required.

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal work and hazard statement are required.