Benzenesulfonic acid, 4-C10-12-sec-alkyl derivs.-, compds. with 2-propanamine

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Test guideline 2

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

Test material information

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:

other: No signs of toxicity

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.