4-(cyclohexylamino)butane-1-sulfonic acid

Endpoint summary

Description of key information

In an acute oral toxicity study with the substance performed in accordance with OECD 423, an LD50 of >2000 mg/kg bw was determined. As no mortality occurred, the LD50 cut-off value was considered to be 5000 mg/kg body weight according to the OECD 423 test guideline.

Based on the expert statement and as the criteria in Column 2 of Section 8.5.2 of REACH are not fulfilled testing by the inhalation route is not performed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Aug 2019 - 16 Oct 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

December 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines, including the most recent revisions.

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at the initiation of dosing: Young adult animals (approx. 8-9 weeks old)
- Weight at the initiating of dosing: 150 to 198 g
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item.
- Housing: Group housing of 3 animals of the same dosing group in polycarbonate cages (Makrolon MIV type), containing sterilized sawdust as bedding material equipped with water bottles.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18 – 24 (actual daily mean: 21)
- Humidity (%): 40 - 70 (actual daily mean: 33 - 68)
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

GAVAGE METHOD: syringe with a plastic gavage cannula attached

Frequency: single dosage, on Day 1.

VEHICLE
The vehicle was selected based on trial preparations.

DOSAGE PREPARATION
Test item dosing formulations (w/w) were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements. The dosing formulations were kept at room temperature until dosing (and used within 4 hours after preparation). The dosing formulations were stirred until and during dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 groups of 3 females in a stepwise manner

Control animals:

no

Details on study design:

The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. The first group was treated at a dose level of 2000 mg/kg. Based on the results, one additional group was dosed at 2000 mg/kg.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Moribundity checks: Twice daily, in the morning and at the end of the working day.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (at least 3 times) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
- Other examinations performed: none.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and/or piloerection were noted for all animals between Days 1 and 6.

Body weight:

lower than 10% body weight loss

Remarks:

The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study with the substance in 6 female rats, performed in a stepwise manner according to OECD/EC test guidelines, an LD50 of >2000 mg/kg bw was determined. As no mortality occurred, the LD50 cut-off value was considered to be 5000 mg/kg body weight according to the OECD 423 test guideline.

Executive summary:

The acute oral toxicity of 4-(cyclohexylamino)butane-1-sulfonic acid was determined in accordance with OECD guideline 423 (2001) and according to GLP principles. The substance was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. No mortality occurred. Hunched posture and/or piloerection were noted for all animals between Days 1 and 6. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The acute oral toxicity (LD50) was determined to be > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

The acute oral toxicity of the substance was determined in accordance with OECD 423 (2001) and according to GLP principles. The substance was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. No mortality occurred. Hunched posture and/or piloerection were noted for all animals between Days 1 and 6. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The acute oral toxicity (LD50) was determined to be > 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 5000 mg/kg body weight. 

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, the substance does not need to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).