Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4.11.-18.11.1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP (performed 1982), comparable to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene

EC Number:

270-128-1

EC Name:

Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene

Cas Number:

68411-46-1

Molecular formula:

C16H19N - C28H43N (main constituents)

IUPAC Name:

Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Measured for Batch: Density 0.976 g/ml; refraction index (20°C) = 1.571; nitrogen content 4.6%; further components quantified by gas chromatography

Specific details on test material used for the study:

- Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tiertarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 170-221 g
- Fasting period before study: overnight prior to dosing
- Housing: 5 animals per Macrolon cage type 3 with standardized soft wood bedding (Societe Parisienne dessciures, Pantin)
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observation: Mortality: daily, a.m. and p.m. on working days. Clinical signs: daily. Body weight: on days 1, 7, 14, and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: sedation, dyspnea, exophtalmus, ruffled fur, and curved body position; body weight

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: The animals recovered within 13 days.

Gross pathology:

No compound related gross organ changes were observed.

Any other information on results incl. tables

SIGNS AND SYMPTOMS

Observations

Exposure day: hours

Days of post-exposure period

1

2

3

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

5000mg/kg

sedation

xx

xx

xx

xx

dyspnoea

x

x

x

x

x

x

x

x

x

x

x

x

x

x

exophtalmus

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

ruffled fur

xx

xx

xx

xx

xx

x

x

x

x

x

x

x

x

x

x

body position-curved

x

x

x

xx

x

x

x

x

x

x

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CAS 68411-46-1 did not cause mortality when administered orally at a single dose of 5000 mg/kg bw to the albino rat.