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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
EC Number:
284-664-9
EC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
Cas Number:
84961-74-0
IUPAC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine (1:1)
- Substance type: technical product (BIO-SOFT 411-E)
- Physical state: viscous liquid
- Analytical purity: 97%
- Lot/batch No.: 50148
- Expiration date of the lot/batch: 30 June 2013
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratoties UK Ltd.
- Age at study initiation: 8 -12 weeks
- Housing: up to 4 animals/group, suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): AT LEAST 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no vehicle used
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

In the absence of toxicity data of the test material a dose of 300 mg/kg bw was applied initially to one animal. Since no mortality was observed 1 more animal was used to test the higher dose of 2000 mg/kg bw. No mortality was detected; four aditional animals were treated with a single gavage dose of 2000 mg/kg bw.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
One animal tested at 300 mg/kg bw, five animals treated with 2000 mg/kg bw.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 h post-treatment and daily for 14 days. Morbity/mortality checks twice per day. Weighing on Day 0, Day 7 and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy.
Statistics:
not required

Results and discussion

Preliminary study:
No toxic effects were seen in the sighting study at 300 mg/kg bw.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks:
97% LAS IPA
Mortality:
No mortality observed
Clinical signs:
No signs of toxicity
Body weight:
No significant changes seen in body weights
Gross pathology:
No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine has an oral LD50 higher than 2000 mg/kg bw.

Executive summary:

In the preliminary phase of an acute oral toxicity study (fixed dose) fasted young adult female Wistar rats (one per dose) were given a single oral dose of  benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) (97%) at doses of   300 or 2000  mg/kg bw. No effects on the animals were seen at both dose levels, and therefore, the main study was performed with the higher dose of 2000 mg/kg bw, as a solution in arachis oil BP.

 

 Oral LD50females> 2000 mg/kg bw

No adverse effects were detected.   

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) is of low toxicity based on an LD50 higher than the classification criterion. The substance shall not be labelled for acute oral toxicity.