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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:
2014-09-12 to 2014-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study under GLP without relevant deviations on the registered substance itself.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
valid from 2014-07-11
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
3-(Cyclohexylamino)-propane sulfonic acid
IUPAC Name:
3-(Cyclohexylamino)-propane sulfonic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 3-(Cyclohexylamino)-propane sulfonic acid
- Substance type: Pure compound
- Purity test date: 2014-09-03
- Batch No.: 08140015/107
- Expiration date of the lot/batch: 2017-08-15
- Storage condition of test material: in a container made of plastic, at temp. 15-25°C
- Other: Date of production: 2014-08-13

Test animals

Species:
rat
Strain:
other: Wistar (Crl: WI(Han); outbred)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Experimental Medicine Centre at the Medical University in Białystok
- Age at study initiation: 9 weeks (sighting study) / 10 weeks (main study)
- Weight at study initiation: 207-228 g
- Fasting period before study: yes, approx. 19h
- Housing: The animals were kept in plastic cages covered with wire bar lids. The dimensions of cages were 58 x 37 x 21 cm (length x width x height). In the sighting study, the animal was caged individually. In the main study, there were four animals in one cage. UV-sterilized wood shavings were used as bedding
- Diet (e.g. ad libitum): “Murigran” standard granulated laboratory fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz (Batch No 3/14 and 4/14) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24 °C
- Humidity (%): 40 – 85%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 60 mg/mL or 400 mg/mL
- Amount of vehicle (if gavage): 0.5 mL / 100 g bw

MAXIMUM DOSE VOLUME APPLIED: 0.5 mL / 100 g bw
Doses:
300 mg/mL or 2000 mg/mL
No. of animals per sex per dose:
1 animal (each for gavage of 300 or 2000 mg/kg bw in sighting study)
4 animals (main study)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of all animals for morbidity and mortality was conducted twice a day or once a day (on days off). The detailed clinical observations were performed on the day of test item administration (day 0), i.e. 10, 30, and 60 minutes after the administration and then at hourly intervals up to the 5th hour after the administration. From the 1st to the 14th day of the experiment, the detailed clinical observations were performed once a day.
- Necropsy of survivors performed: gross examination comprised an observation of the external body surface, all natural apertures, and the cranial, thoracic, and abdominal cavities with their contents
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
Following single administration of test item at a dose of 300 mg/kg b.w. to the first animal used in the sighting study, no changes were found in the animal during the entire period of observation. The animal survived the experiment.
Following single administration of test item at a dose of 2000 mg/kg b.w. to the second animal used in the sighting study, no changes were found in the animal during the entire period of observation. The animal survived the experiment.
Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Remarks on result:
other: All 5 animals given 2000 mg/kg survived the experiment
Mortality:
Following single administration of test item at a dose of 2000 mg/kg b.w. to all five animals, no changes were found in the animals during the entire period of observation. All animals survived the experiment.
Clinical signs:
Following single administration of test item at a dose of 2000 mg/kg b.w. to all five animals, no changes were found in the animals during the entire period of observation.
Body weight:
During the 14-day experiment, body weight gain was found in all animals.
Gross pathology:
No lesions were found at gross necropsy of all animals.

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The study was conducted under GLP according to OECD guideline 420 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation. Hence, the results can be considered as reliable to assess the acute oral toxicity in rats.
Following single administration of 3-(Cyclohexylamino)-propane sulfonic acid at a dose of 2000 mg/kg b.w. to five female rats no signs of toxicity were found. All animals survived the period of experiment. After the experiment, body weight gain was found in all animals. Gross examination did not reveal any lesions in animals, which leads in summary to the following results: LD0(oral) ≥ 2000 mg/kg bw; LD50(oral) > 2000 mg/kg bw.
On the grounds of the obtained results, 3-(Cyclohexylamino)-propane sulfonic acid, can be classified to the following categories:
- category 5 / unclassified – according to the Globally Harmonized System (GHS),
- agents which are beyond categorization – according to the Regulation (EC) No. 1272/2008
Executive summary:

In an acute oral toxicity study (OECD 420), fasted, 9-10 week old female Wistar (Crl: WI(Han); outbred) rats were given a single oral dose of 3-(Cyclohexylamino)-propane sulfonic acid in water at doses of 300 mg/kg bw (1 female, sighting study) or 2000 mg/kg bw (1 female, sighting study, 4 females, main study) and observed for 14 days.

 

Following single administration of the test item at a dose of 2000 mg/kg b.w. to all animals used in the main study no signs of toxicity were found. All animals survived the period of experiment. After the experiment, body weight gain was found in all animals. Gross examination did not reveal any lesions in animals. Hence, the following results could be gained:

 

LD0(oral) ≥ 2000 mg/kg bw

LD50(oral) > 2000 mg/kg bw

 

3-(Cyclohexylamino)-propane sulfonic acid is of low Toxicity based on the LD50 determined. 3-(Cyclohexylamino)-propane sulfonic acid, can be classified to the following categories:

- category 5 / unclassified – according to the Globally Harmonized System (GHS),

- agents which are beyond categorization – according to the Regulation (EC) No. 1272/2008