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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
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:
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

Administration / exposure

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)

Results and discussion

Effect levelsopen allclose all
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

Applicant's summary and conclusion