Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with isopropanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 September to 09 October 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

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.-, compd. with 1-aminopropane-2-ol

EC Number:

939-479-4

Cas Number:

1471311-60-0

Molecular formula:

not applicable, UVCB

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1)
- Name of product (as cited on Certificate of Analysis): MARLON AMI 80
- Substance type: technical product
- Physical state: yellow-brown viscous liquid
- Analytical purity: 78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol (communication with sponsor)
- Lot No.: 126
- Expiration date of the lot: 01 June 2013
- Storage condition of test material: room temperature in the dark
- Other: data not verified by the laboratory; identity details were supplied by the Sponsor

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.
- Age at study initiation: 8-12 weeks
- Weight at study initiation:
- Fasting period before study: yes
- Housing: in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: d libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 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:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL (dose 300 mg/kg bw preliminary test), 200 mg/ml (dose 200 mg/kg bw), 300 mg/ml (dose 300 mg/kg bw main study)
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: the product did not dissolve/suspend in distilled water

MAXIMUM DOSE VOLUME APPLIED: 300 mg/ml

Doses:

sighting study: product doses 300 and 2000 mg/kg bw; active substance doses 234 and 1560 mg/kg bw
main study: product dose 300 mg/kg bw, active substance dose 234 mg/kg bw

No. of animals per sex per dose:

4 + 1 (main study), 1 (preliminary study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were performed 0.5, 1, 2, and 4 h after dosing and thereafter daily for up to 14 days. Weighing was performed on Day 0, Day 7 and Day 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

Not used

Results and discussion

Preliminary study:

The animal treated with the highest dose (2000 mg/kg bw) was found dead 4 h post-treatment. At this dose level ataxia, hunched posture, lethargy and ptosis were observed, while at the necropsy the findings reveal dark liver and kidneys, liquid and gas accumulated in the stomach and haemorrhagic gastric mucosa. The main study was continued with the dose of 300 mg/kg bw.

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 234 - < 1 560 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality.

Clinical signs:

other: Hunched posture in all animals, ataxia in one animal during the first day. The signs disappeared one day post-treatment.

Gross pathology:

No abnormalities detected.

Other findings:

No other findings.

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1)is of slight toxicitybased on the LD50range infemales. The substance shall be labelled as Acute Tox. 3.

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 MARLON AMI 80 (78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol)at doses of   300 or 2000  mg/kg bw (product dose). The animal treated with the highest dose was found dead and therefore the main study was performed with the lower dose of 300 mg/kg bw (active substance: 234 mg/kg bw).

234 mg/kg bw>Oral LD50 females mg/kg bw < 1560 mg/kg bw

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1)is of slight toxicity based on the LD50 range in females. The substance shall be labelled as Acute Tox. 3.