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

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 4640 mg/kg bw
Acute inhalation toxicity: LD50 > 1.16 mg/L (maximum attainable dust concentration)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-12-15 to 1977-06-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable study report

Qualifier:

according to guideline

Guideline:

other: according to BASF-internal standard

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males 200 g, females 160 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

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

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

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Test concentration used: 10 % and 15 % (G/V)
- Amount of vehicle (if gavage): dose level 1000 mg/kg bw 1.13 mL; dose level 4640 mg/kg bw 5.26 mL

MAXIMUM DOSE VOLUME APPLIED: males: 30.9 mL/kg bw

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

Doses:

1000 and 4640 mg/kg (due to technical reasons, higher concentrations and thereby higher dose levels could not be administered)

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
- 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)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 640 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 4 640 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: no adverse effects reported

Gross pathology:

no abnormal observations

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

4 640 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1976-03-09 to 1977-06-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Inhalation hazard test with acceptable restrictions (limited documentation)

Qualifier:

according to guideline

Guideline:

other: according to H.F. Smyth and C.P. Carpenter, J. Ind. Hyg. Toxicol. 28, 1944

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

limited documentation

GLP compliance:

no

Test type:

other: inhalation hazard test

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: mean of three males 583 g; mean of three females 492 g
- Diet: The animals were offered a standardized animal laboratory diet Altromin R 1324 (Altromin GmbH, Lage, Germany)

IN-LIFE DATES: From: 1976-03-09 To: 1976-03-17

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

other: air was cleansed via passage through a washing flask

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exciccator, washing flask
- Source and rate of air: at room temperature air was saturated with test item via passage through a 5 cm thick layer of the test item at a rate of 200 L air per h.
- Method of conditioning air: see above
- System of generating particulates: substance with slight dustiness
- Temperature, humidity, pressure in air chamber: room temperature, ambient conditions

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

Mean concentration 1.16 mg/L.
No analytical determination of the atmosphere concentrations was performed. The nominal concentrations were calculated as quotient of the of the amount of test substance weight loss during exposure and the amount of air used during the exposure.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: on days 0, 1, 2, 7, and 8
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.16 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

8 h

Mortality:

None

Clinical signs:

other: None reported

Body weight:

Normal body weight development reported

Gross pathology:

Nothing abnormal detected

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

1 160 mg/m³ air

Additional information

Acute oral toxicity study with the rat (key study)

The study was performed to determine the acute toxicity following oral administration of the test item applied as a suspension in 0.5% aqueous CMC preparation with 2 - 3 drops Cremophor EL, in Wistar rats. The study procedure was based on BASF internal testing standards. To a group of 20 fasted animals (5 males, 5 females per dose) a single oral dose of the test material preparation at dose levels of 1000 and 4640 mg/kg bw was given. No mortalities or other signs of toxicity were noted. The expected body weight gain has been observed in the course of the study. No abnormalities were noted at necropsy of animals sacrificed at the end of this study. Under the conditions of this study the median lethal concentration of the test item after oral application was found to be greater than 4640 mg/kg bw for the male and female animals.

Acute inhalation toxicity (supporting information)

For determination of the acute inhalation toxicity (single 8-h-exposure) of the test item as a dust, a study with 3 male and 3 female Wistar rats was performed according to the method described in H.F. Smyth and C.P. Carpenter, J. Ind. Hyg. Toxicol. 28, 1944. The maximum attainable dust concentration of 1.16 mg/L (nominal) was tested. No mortality occurred at this concentration. The 8h-LC50 for male and female animals therefore is > 1.16 mg/L. No clinical signs or pathologic findings at necropsy were reported. Body weight development of the animals was not influenced. These data are only considered as orientating information about the inhalation hazard (no analytical verification of the test item concentration, 8 h exposure time, no GLP).

Justification for selection of acute toxicity – oral endpoint
Scientifically acceptable study report.

Justification for selection of acute toxicity – inhalation endpoint
Only orientating information about the inhalation hazard (no analytical verification of test item concentration, 8 h exposure time, no GLP)

Justification for classification or non-classification

Acute oral toxicity

 

Dangerous Substance Directive (67/548/EEC) 

The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is considered not to be classified for acute oral toxicity.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for acute oral toxicity.

 

  

Acute inhalation toxicity

 

Dangerous Substance Directive (67/548/EEC) 

The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is considered not to be classified for acute inhalation toxicity.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for acute inhalation toxicity.