Sodium cumenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

publication

Title:

Acute oral toxicity of Na cumene sulfonate 0019

Author:

Huels AG,

Year:

1982

Bibliographic source:

Huels AG, Marl, Germany.

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:

no

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 cumenesulphonate

Test material form:

solid

Specific details on test material used for the study:

CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%
Remarks: Substance tested is a granular solid

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:

feeding ad libitum (food was withheld 16 hours prior to dosing).

Doses:

Single oral administration of 7000 mg/kg bw (vehicle water); no controls;
feeding ad libitum (food was withheld 16 hours prior to dosing).

No. of animals per sex per dose:

5/sex/dose group

Control animals:

no

Details on study design:

Observations:
• Mortality/clinical signs continuously for 6 hours on day 1 and daily until day 14.
• Body weights on day 1, 7 and 14.
• Necropsy on day 14 (3/sex/dose group).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Based on:

test mat.

Mortality:

male: 0/5
female 2/5

Clinical signs:

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.

Body weight:

No effects.

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

Value: Oral LD50 >7000 mg/kg bw

 

Dose [mg/kg bw] effect		7000			DR
Sex	Day	M	F	M		F
Mortality	1-14	0/5	2/5
Clinical signs(A)	1-14	+	+
Body weight	1-14	No treatment related effects
Necropsy(B)	14		+

(A)Clinical observations included increased piloerection, ataxia, lateral recumbency and

increased water intake (lasting 24 hours after dosing).

(B)In the animals that died redness of the stomach mucosa was observed.

DR is dose related. (delete this column and line; it’s not dose related since there was only

one dose.)

 

Applicant's summary and conclusion

Interpretation of results:

other: practically nontoxic

Conclusions:

The acute oral LD50 in male/female rats is > 7000 mg/kg bw. No significant gross abnormalities were seen at autopsy.