p-tert-butylaniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study conducted prior to GLP, no guideline followed as none was available in 1982 (OECD 401: 1987). However, the available information is documented sufficiently and allows the conclusion that the study was properly conducted with a scientifically acceptable method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-tert-butylaniline

EC Number:

212-215-9

EC Name:

p-tert-butylaniline

Cas Number:

769-92-6

Molecular formula:

C10H15N

IUPAC Name:

4-tert-butylaniline

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Winkelmann, Borchen
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: 173 g (average)
- Housing: In groups of five in Makrolon cages type III on low-dusting wood pellets
- Diet (e.g. ad libitum): Altromin R 1324 (Altromin GmbH und Co KG, Lage) ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5 °C
- Humidity (%): 60 ± 5%
- Photoperiod (hrs dark / hrs light): 12 / 12 (artificial light from 7 am to 7 pm)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0.5 mL/kg (=472 mg/kg)
0.6 mL/kg (=566.4 mg/kg)
0.65 mL/kg (=613.6 mg/kg)
0.8 mL/kg (=755.2 mg/kg)
1.0 mL/kg (=944 mg/kg)
1.2 mL/kg (=1132.8 mg/kg)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on application day, otherwise twice a day for clinical symptoms, weighing on day 0 and 14
- Examinations performed: clinical signs, body weight, autopsy (randomly)

Statistics:

The LD50 (confidence interval for p ≤ 0.05) value was calculated by programmed probit analysis according to Fink & Hund (Arzneim.-Forsch. 15, 1965, 624).

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

0.68 mL/kg bw

Based on:

test mat.

Remarks on result:

other: =642 mg/kg bw

Mortality:

Animals died in all dose groups except for the lowest dose group.

Clinical signs:

other: Poor general conditions, cyanosis, prone/lateral position, narcosis, slight reflexes, ruffled fur, bloody and watery eyes.

Gross pathology:

All animals killed after 14 days and animals that died during the test were without pathological findings.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The study was conducted similar to OECD guideline 401 on the registered substance itself [1981 prior to GLP, no guideline followed as none was available (OECD 401: 1987)]. The available information is documented sufficiently and allows the conclusion that the study was properly conducted with a scientifically acceptable method. Hence, the results can be considered as sufficiently reliable to assess the acute oral toxicity in rats. The determined LD50 value is 0.68 mL/kg bw (=642 mg/kg bw). The result is suitable to determine the classification of the substance; according to Regulation (EC) No. 1272/2008, the substance has to be classified as acute toxic cat. IV.

Executive summary:

In an acute oral toxicity study (no GLP) from 1981 similar to the later OECD Guideline 401, groups of 9 weeks old, male Wistar rats (10/dose) were given oral doses (0.5 mL/kg =472 mg/kg; 0.6 mL/kg =566.4 mg/kg; 0.65 mL/kg =613.6 mg/kg; 0.8 mL/kg =755.2 mg/kg; 1.0 mL/kg =944 mg/kg; 1.2 mL/kg =1132.8 mg/kg; via gavage) of the test substance and observed for 14 days.

 

Oral LD50 = 0.68 mL/kg bw = 642 mg/kg bw; the test substance has to be classified as acute toxic cat. IV according to CLP.