Sodium 3-chloro-2-hydroxypropanesulphonate

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

Analytical confirmation of the concentration, homogeneity, and stability of the dosing formulations was not performed. Due to the short duration of the study, this exception would not have an impact on the interpretation of the study results.

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-chloro-2-hydroxypropanesulphonate

EC Number:

204-807-0

EC Name:

Sodium 3-chloro-2-hydroxypropanesulphonate

Cas Number:

126-83-0

Molecular formula:

C3H7ClO4S.Na

IUPAC Name:

sodium 3-chloro-2-hydroxypropanesulphonate

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9-11 weeks
- Weight at study initiation: 182.4 to 228.8 g
- Fasting period before study: yes, overnight
- Housing: all animals were housed individually in clean, stainless steel, wire-mesh cages containing bedding material, and enrichment devices were provided to all animals
- Diet: ad libitum except during fasting
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22.4 to 22.6°C
- Humidity: 36.1 to 58.3%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% methylcellulose in deionized water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: The rats were observed twice daily, once in the morning and once in the afternoon, for mortality and moribundity. The rats were observed at time of dosing, at approximately 15 ± 5 minutes and 1, 2, and 4 hours post-dosing on study Day 0, and once daily thereafter for 14 days.
- Frequency of observations and weighing: Body weights were obtained and recorded on study days 0 (initiation), 7, and 14 (termination)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived to the scheduled necropsy

Clinical signs:

There were no test substance-related clinical observations at 300 mg/kg. Test substance-related clinical findings of soft feces, rectal mucous exudate, and/or wet yellow material around the anogenital area were noted in 4/5 animals dosed at 2000 mg/kg at 1, 2 and/or 4 hours following dose administration on Study Day 0. No clinical observations were noted during the 14-day observation period.

Body weight:

There were no remarkable body weight changes noted during the study. All animals surpassed their initial body weight by Study Day 14.

Gross pathology:

There were no test substance-related macroscopic findings at the scheduled necropsy. Macroscopic findings were limited to a small thyroid gland in a single 2000 mg/kg group animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female): >2000 mg/kg

Executive summary:

The objectives of this study were to determine the estimated acute oral median lethal dose range and evaluate potential systemic toxicity of the test substance when administered as a single dose to albino rats according to OECD Guideline 420. The acute oral toxicity of the test substance was evaluated in this single-dose study in rats. The test substance was administered once orally via gavage to 1 fasted female albino rat at a dose level of 300 mg/kg. No mortality was observed, and another female rat was dosed at 2000 mg/kg (limit dose). No mortality was observed, and 4 additional female animals were dosed at 2000 mg/kg. Mortality, clinical observations, and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy.

There were no deaths, remarkable body weight changes, or test substance-related gross necropsy findings. There were no test substance-related clinical observations at 300 mg/kg. Test substance-related clinical findings of soft feces, rectal mucous exudate, and/or wet yellow material around the anogenital area were noted in 4/5 animals dosed at 2000 mg/kg at 1, 2 and/or 4 hours following dose administration on Study Day 0. No clinical observations were noted during the 14-day observation period. Based on the results of this study, the estimated LD50 of the test substance was greater than 2000 mg/kg when administered once orally via gavage to fasted female albino rats.