4-amino-N-(2-ethylhexyl)benzenesulphonamide

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1975-12-15 to 1977-06-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable study report, study however disregarded as intraperitoneal application is no appropriate route of test item exposure.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: according to BASF internal standard

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-N-(2-ethylhexyl)benzenesulphonamide

EC Number:

258-799-9

EC Name:

4-amino-N-(2-ethylhexyl)benzenesulphonamide

Cas Number:

53817-09-7

Molecular formula:

C14H24N2O2S

IUPAC Name:

4-amino-N-(2-ethylhexyl)benzene-1-sulfonamide

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males 20 g, females 26 g
- Diet: The animals were offered a standardized animal laboratory diet Altromin R 1324 (Altromin GmbH, Lage, Germany)

IN-LIFE DATES: From: 1977-06-29 To: 1977-07-13

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Details on exposure:

VEHICLE
- Concentration in vehicle: Test concentration used: 15 %, 14.7 %, and 10 % (G/V)
- Amount of vehicle (if gavage): males 0.29 mL, females 0.37 mL

MAXIMUM DOSE VOLUME APPLIED: males: 14.32 mL/kg bw

DOSAGE PREPARATION: Suspension in 0.5% aqueous CMC preparation with 2 - 3 drops Cremophor EL

Doses:

1000, 1470, 2150 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Other examinations performed: clinical signs, body weight
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: normal weight development reported, however no further details are given
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (dyspnoe, apathy, dorsal or lateral position, tumbling, atony, narcotic-like state, spasmodic behaviour, tonic spasms, lacrimation, poor general condition, skin/fur, tremor, feces, urine)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 200 mg/kg bw

Based on:

test mat.

Mortality:

1000 mg/kg: 2/10 after 14 days; 1470 mg/kg: 8/10 after 14 days; 2150 mg/kg: 10/10 after 14 days

Clinical signs:

Dyspnea, apathy, abdominal and lateral position, staggering, atony, partly narcotic-like state, missing pain and cornea reflexes, spastic gait, tonic spasms, lachrymation, poor general state.

Body weight:

Normal body weight growth

Gross pathology:

Intra-abdominal substance residues and adherences, liver with slightly rounded edges

Any other information on results incl. tables

Table: Number of dead animals after respective exposure duration

 

Dose (mg/kg bw)	Test item conc. (%)	No. of animals	1 h	24 h	48 h	7 d	14 d
2150	15	5 M	0	5	5	5	5
2150	15	5 F	0	5	5	5	5
1470	14.7	5 M	0	2	3	3	3
1470	14.7	5 F	0	5	5	5	5
1000	10	5 M	0	0	1	1	1
1000	10	5 F	0	0	1	1	1

 

Applicant's summary and conclusion

Executive summary:

The study was performed to determine the acute toxicity following intraperitoneal administration of the test item, applied as a suspension in CMC, in NMRI mice. The study procedure was based on the BASF internal testing standards. To a group of 30 fasted animals (5 males, 5 females per dose level) a single oral dose of the test material preparation at dose level of 1000, 1470, and 2150 mg/kg bw was given. Mortalities occurred. Other signs of toxicity were dyspnea, apathy, abdominal and lateral position, staggering, atony, partly narcotic-like state, missing pain and cornea reflexes, spastic gait, tonic spasms, lachrymation, poor general state. The expected body weight gain has been observed in the course of the study. Effects noted at necropsy were intra-abdominal substance residues and adherences, and liver with slightly rounded edges. Under the conditions of this study the median lethal concentration of the test item after intraperitoneal application was found to be ca. 1200 mg/kg bw. for the male and female animals. The study however was disregarded, as an oral acute toxicity study with the rat is available, which is considered to be the key study as it delivers the more appropriate data for the use in classification and labelling and chemical safety assessment.