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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Referenceopen allclose all

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 5 minutes. The hydrolysis products have been identified to be 1-propanol and titanium dioxide. The discussion of toxicokinetics is based on the hydrolysis/degradation products.
Endpoint:
screening for reproductive / 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
Qualifier:
according to guideline
Guideline:
other: other
Principles of method if other than guideline:
Male animals were treated for 42 days, then mated with untreated virgin females . Resulting pregnant females were sham exposed on gestation days 1-19 (experiment 1). Another group of untreated males and females were mated. Resulting pregnant females were then exposed to the test substance on gestation days 1-19 (experiment 2).
GLP compliance:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure (if applicable):
whole body
Vehicle:
air
Duration of treatment / exposure:
Experiment 1
- Males : 6 weeks premating
- Females: sham exposed


Experiment 2
- Males: sham exposed
- Females: day 1-19 of gestation
Frequency of treatment:
7 h/day. 7 days/week.
Dose / conc.:
0 mg/m³ air (nominal)
Dose / conc.:
8 730 mg/m³ air (nominal)
Dose / conc.:
17 460 mg/m³ air (nominal)
Dose / conc.:
24 940 mg/m³ air (nominal)
No. of animals per sex per dose:
female 15; male 18
Reproductive function: oestrous cycle:
no effects observed
Key result
Dose descriptor:
NOAEC
Effect level:
ca. 8 730 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Based on the reversible fertility effects
Key result
Dose descriptor:
NOAEC
Generation:
F1
Effect level:
ca. 3 500 ppm (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
8 730 mg/m³ air
Treatment related:
no
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
8 730 mg/m³
Study duration:
subchronic
Species:
rat
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No studies were conducted on the target substance, titanium tetrapropanolate. As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance, 1 -propanol.

 

In inhalatory studies on rats, Nelson et al (1985, 1989) observed no maternal or fetal effects at 3500 ppm (8730 mg/m3) 1-propanol. Based on the finding the NOAEC fertility was established at 3500 ppm (8730 mg/m3)

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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.

Additional information