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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: Read across from another member of the category

Adequacy of study:

key study

Study period:

1982-08-25 to 1982-09-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium p-cumenesulphonate

EC Number:

239-854-6

EC Name:

Sodium p-cumenesulphonate

Cas Number:

15763-76-5

Molecular formula:

C9H12O3S.Na

IUPAC Name:

sodium 4-isopropylbenzenesulfonate

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 daysENVIRONMENTAL 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

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 720 mg/kg bw

Based on:

act. ingr.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Based on:

test mat.

Mortality:

male: 0/5female 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 bw corresponding to > 6720 mg/kg bw based on active ingredient.

Executive summary:

The acute Oral Toxicity of Sodium p-cumenesulhonate was assessed following official method OECD 423, Acute Toxic Class Method. The limit test was performed with a single dose of 7000 mg/kg bw based on test material administered to both males and females Wistar rats.

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.

Post mortem reddening of the gastric mucosa was observed, the surviving animals showed no pathological changes in organs at necropsy. The test results are considered applicable for potassium p-cumenesulphonate based on the chemical similarity.