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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 30 minutes. The hydrolysis products have been identified to be 2-propanol, triethanolamine and titanium dioxide. The discussion of toxicological properties is based on the hydrolysis/degradation products.
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
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
Additional information

No studies were conducted on the target substance. 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)

 

NOEL of TEA was estimated 1000 mg/kg/day (Disseminated dossier, Source: European Chemicals Agency,http://echa.europa.eu/, cited in Mark Selby, 2013)

 

Effects on developmental toxicity

Link to relevant study records

Referenceopen allclose all

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:
comparable to guideline study
Justification for type of information:
2-propanol is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
Concentration of dosing formulations were confirmed by gas chromatography (Hewlet Packard 5890A), with a 30mm x 0,32mm (i.d) capillary column. All formulations were within 97.1-106% of target concentration
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
artificial insemination
Duration of treatment / exposure:
From day 6 to 18 of gestation
Frequency of treatment:
Daily
Dose / conc.:
120 mg/kg bw/day (nominal)
Dose / conc.:
240 mg/kg bw/day (nominal)
Dose / conc.:
480 mg/kg bw/day (nominal)
No. of animals per sex per dose:
A total of 15 females per dose were treated; two females in the 120 mg/kg bw/day dose group were not pregnant at sacrifice.
Control animals:
yes, concurrent vehicle
Clinical signs:
effects observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Key result
Dose descriptor:
NOAEL
Effect level:
240 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
clinical signs
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
480 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: overall effects
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
480 mg/kg bw/day (actual dose received)
Treatment related:
no
Conclusions:
Based on study on 2-propanol, the target substance does not have developmental toxicity.
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
2-propanol is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
Concentration of dosing formulations were confirmed by gas chromatography (Hewlet Packard 5890A), with a 30mm x 0,32mm (i.d) capillary column. All formulations were within 97.1-106% of target concentration
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
artificial insemination
Duration of treatment / exposure:
From day 6 to 18 of gestation
Frequency of treatment:
Daily
Dose / conc.:
120 mg/kg bw/day (nominal)
Dose / conc.:
240 mg/kg bw/day (nominal)
Dose / conc.:
480 mg/kg bw/day (nominal)
No. of animals per sex per dose:
A total of 15 females per dose were treated; two females in the 120 mg/kg bw/day dose group were not pregnant at sacrifice.
Control animals:
yes, concurrent vehicle
Clinical signs:
effects observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Key result
Dose descriptor:
NOAEL
Effect level:
240 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
clinical signs
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
480 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: overall effects
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
480 mg/kg bw/day (actual dose received)
Treatment related:
no
Conclusions:
Propan-2-ol was not teratogenic when administered orally during GD6-18 to rabbits. By the publication, the NOAEL for maternal toxicity was 240 mg/kg/day and the NOAEL for developmental toxicity was 480 mg/kg/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Dose descriptor:
NOAEL
480 mg/kg bw/day
Study duration:
subchronic
Species:
rabbit
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