Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Study duration:
chronic
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

No studies were conducted on the target substance, Tetrakis [[2,2',2"-nitrilotris[ethanolato]](1-)-N,O]zirconium. As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance, triethanolamine (TEA).

 

There were no studies available on fertility although there were no abnormalities noted in the histopathological examination of reproductive organs (testes and ovaries) in the 90-day oral and dermal toxicity studies. There was no evidence of developmental toxicity in the offspring of pregnant rats and mice (exposed during the major period of organogenesis to up to 30 mg/kg/day, and to 1125 mg/kg/day respectively using the oral route). (OECD SIDS 1995)

Link to relevant study records

Referenceopen allclose all

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.
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
Species:
mouse
Strain:
CD-1
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
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
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
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
Key result
Abnormalities:
no effects observed
Remarks on result:
not measured/tested
Abnormalities:
not specified
Developmental effects observed:
not specified
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.

Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
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.
Reason / purpose:
read-across source
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
Species:
mouse
Strain:
CD-1
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
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
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
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
Key result
Abnormalities:
no effects observed
Remarks on result:
not measured/tested
Abnormalities:
not specified
Developmental effects observed:
not specified
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:

The study was conducted on triethanolamine, the strucural analogue and also the hydrolysis product of the target substance. As the target substance is hydrolytically unstable, its intrinsic property lies in the the hydrolysis products. The result is used as weight of evidence approach in hazard assessment.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 125 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the studies, there's no adverse effect on reproduction observed. Therefore, there is no need for classification as reproductive toxicity according to CLP Regulation.