Benzyldimethylamine

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 407

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldimethylamine

EC Number:

203-149-1

EC Name:

Benzyldimethylamine

Cas Number:

103-83-3

Molecular formula:

C9H13N

IUPAC Name:

benzyldimethylamine

Details on test material:

N,N-Dimethylbenzylamine (Desmorapid DB) no further data

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males 158.5-184.5 g femalew:116.1-153.9 g
- Housing: 5
- Diet ad libitum
- Water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on exposure:

The test article was administered daily by gavage for 28 days

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

he achieved concentration was measured during week 1 and week 2 the analytical procedure HUK624/1-01F

Duration of treatment / exposure:

28 days

Frequency of treatment:

once daily

Duration of test:

28 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0. 6, 30 or 150 mg/kg bw/day
Basis:

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

according to the respective OECD TG 407
CAGE SIDE OBSERVATIONS:
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily , full examination weekly
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION weekly:
WATER CONSUMPTION by visual appraisal:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 4
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: week 4
GROSS PATHOLOGY: Yes
Organ weights
adrenals liver kidneys testes
left and right organs were weighed separately
HISTOPATHOLOGY: Yes
tissues from control and high dose animals initially
tissue preservation
adremals, aorta, brain (medullary and cerebellar and cortical sections),
colon (duodenum, caecum, jejunum rectum), kidneys, liver, lungs, lymph nodes (mandibular and nesenteric) ,
eyes and optic nerve, oesophageousm pancreasm prostatem salivary glands, seminal vesicles, spinal cord, stomach,
thymus, trachea, uterus including cervix, ovaries, pituitary gland, femur with bone marrow, mammary gland, sciatic nerve,
skin, spleen, testes with epididymides, thyroid with parathyroids urinary bladder

Statistics:

anlysis of variance, t-test, Kruskal-Wallis test, Wilcoxon test

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

ca. 150 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: There were no effects observed in female reproductive organs. In males at the highest dose groups the mean absolute and relative testis weight was slightly increaased when compared to the respective control.but without histopathological correlate

Observed effects

There were no effects observed in female reproductive organs.
In males at the highest dose groups the mean absolute and relative testis weight was slightly increaased when compared to the respective control. However there was no histopathological correlate and therefeore these effects werenot considered to be of toxicological relevance.

Applicant's summary and conclusion

Executive summary:

In an test according to OECD TG 407 and GLP groups of male and female Crl:CD(SD)BR rats received N,N-Dimethylbenzylamine in corn oil by daily oral gavage at nominal dose levels of 6, 30 or 150 mg/kg bw/day. A further group of the same size received corn oil alone and served as control.

There were no effects observed in female reproductive organs. In males at the highest dose groups the mean absolute and relative testis weight was slightly increaased when compared to the respective control. However there was no histopathological correlate and therefeore these effects were not considered to be of toxicological relevance. Thus , the NOAEL (reproductive organs) was determined to be 150 mg/kg bw/day for male and female rats (BG Chemie 1988)