Benzenesulfonic acid, 4-(1-methylethyl)-, ammonium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: Read across from category (Hydrotropes)

Adequacy of study:

key study

Study period:

1982-08-25 to 1982-09-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium cumenesulphonate

EC Number:

248-983-7

EC Name:

Sodium cumenesulphonate

Cas Number:

28348-53-0

Molecular formula:

C9H12O3S.Na

IUPAC Name:

sodium 2-phenylpropane-2-sulfonate

Details on test material:

- Name of test material (as cited in study report): Na-Cumolsulfonat- Physical state: solid (powder)- Analytical purity: 96.0 %- Impurities (identity and concentrations): not mentioned- Purity test date: not mentioned- Lot/batch No.: 10- Expiration date of the lot/batch: not mentioned- Stability under test conditions: not mentioned- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 141 g (males); 117 g (females), mean weights
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 4 - 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

7000 mg/kg bw (highest technically feasable concentration)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes, 3 male and 3 female animals
- Other examinations performed: no

Statistics:

The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Mortality:

male: 0/5
female 2/5

Clinical signs:

other: One hour after application piloerection, slight ataxia, lateral position and increased water intake was noted. After 24 hours the surviving animals were free of symptoms.

Gross pathology:

Post mortem reddening of the gastric mucosa was observed, the surviving animals showed no pathological changes in organs at necropsy.

Any other information on results incl. tables

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
7000	0/5	2/5	2/10	1 1/2	5/5	5/5	10/10

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 to male and female Wistar rats was greater than 7000 mg/kg bodyweight.