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Toxicological information

Toxicity to reproduction: other studies

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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:
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:
other: OECD TG 407
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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)