Benzenesulfonic acid, 4-C10-13-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:

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

Molecular formula:

N/A

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

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: No signs of toxicity

Gross pathology:

No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in female rats conducted according to OECD 420, no mortality and sign of toxicity occurred at 300 and 2000 mg/kg bw. Based on the results and in accordance with OECD guideline 420 the LD50 was determined to be higher than 2000 mg/kg bw. Thus, the classification of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.

Executive summary:

In an acute oral toxicity study (fixed-dose procedure, OECD 420), one female Wistar rat and then five female Wistar rats were treated with a single dose of 300 mg/kg bw and 2000 mg/kg bw of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs, compd. with 2-propanamine (1:1) (97% purity), by oral gavage respectively, and were observed for 14 days.

All animals survived until the end of the study. The sighting study at 300 mg/kg bw did not show any toxic effects. Therefore, the main study was performed with the higher dose of 2000 mg/kg bw. There were no treatment related clinical signs, necropsy findings or changes in body weight. Based on the results and in accordance with OECD guideline 420 the LD50 value was determined to be higher than 2000 mg/kg bw. Therefore, classification for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.

This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study (OECD 420) in rats.