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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:
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 000 mg/kg bw
Mortality:
male: 0/5female 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:
The treatment had no influence on body weight gain.
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 to male and female Wistar rats was greater than 7000 mg/kg bodyweight.