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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
triethanolamine is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Chernoff-Kavlok teratogenicity screening test
Principles of method if other than guideline:
Post Natal Screening test - (Chernoff and Kavlock, 1982, 1983) The screen consisted of three experimental phases.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
CD-1

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
The daily dosing solutions were prepared and color coded by the chemistry staff at study initiation and were stored refrigerated in amber glass vials to prevent photodegradation. All dosing concentrations were verified as accurate by the chemistry staff. The animal technicians dosing the animals were not aware of the test article name and were blind to doses. Each test article was identified by the number assigned by the Radian Corp. and a corresponding color. This technique allowed for unbiased clinical observations.
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
not specified.
Duration of treatment / exposure:
on days 6-15 of gestation
Frequency of treatment:
daily
Duration of test:
until post partum day 3
Doses / concentrations
Dose / conc.:
1 125 mg/kg bw/day
Remarks:
Phase III
No. of animals per sex per dose:
3 virgin females (Phase I)
2-4 mated females (Phase II)
50 mated females (Phase III)
Control animals:
yes, concurrent vehicle
Details on study design:
Sex: female
Duration of test: up to 3 days post partum

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed

Effect levels (maternal animals)

open allclose all
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 1 125 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 1 125 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Maternal abnormalities

Key result
Abnormalities:
no effects observed

Results (fetuses)

Effect levels (fetuses)

Remarks on result:
not measured/tested

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Oral administration of 1125 mg/kg/day triethanolamine to pregnant mice did not affect maternal mortality, the number of viable litters, litter size, percent survival or pups, or birth weight or weight gained by the pups. No further details of study available.
Executive summary:

As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.