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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 720 mg/kg bw
Based on:
act. ingr.
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.