N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The potential for the test substance to produce acute toxicity after a single oral administration was determined.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

EC Number:

210-043-9

EC Name:

N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

Cas Number:

603-48-5

Molecular formula:

C25H31N3

IUPAC Name:

4-{bis[4-(dimethylamino)phenyl]methyl}-N,N-dimethylaniline

Test material form:

solid

Details on test material:

- Purity: not reported

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. Thomae GMBH, D-7950 Biberach, FRG
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: not reported
- Weight at study initiation: Males, 213 g and Females, 201 g
- Fasting period before study: The animals were given no feed about 16 hours before administration
- Housing: Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: ad libitum, except for approximately 16 hours before administration
- Water: Tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hrs dark (18:00 to 06:00) and 12 hrs light (06:00 to 18:00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% Aqueous carboxymethyl cellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 15 mL/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
- Lot/batch no. (if required): R 243/181
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

5000 mg/kg

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 observations and weighing: Recording of signs and symptoms several times on the day of administration. at least once each workday. Check for moribund and dead animals twice each workday and once on holidays. Animals were weighed at beginning of the test and at 7 and 13 days after dose administration.
- Necropsy of survivors performed: yes

Statistics:

No

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: No clinical signs were observed

Gross pathology:

No gross pathology was found

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg

Executive summary:

Groups of 5 male and 5 female rats were administered by gavage, 5000 mg/kg of the test substance as a suspension in 0.5% aqueous carboxymethyl cellulose. The animals were checked for signs and symptoms several times on the day of administration, and at least once each workday. A check was made for moribund and dead animals twice each workday and once on holidays. After the 14-day observation period, the animals were sacrificed and then necropsy with gross-pathological examination.

 

No deaths occurred and there were no clinical signs of toxicity nor were any pathological changes seen at necropsy. The LD50 of the test substance is >5000 mg/kg.