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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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:
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.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propan-2-ol
EC Number:
200-661-7
EC Name:
Propan-2-ol
Cas Number:
67-63-0
Molecular formula:
C3H8O
IUPAC Name:
propan-2-ol
Details on test material:
- Name of test material (as cited in study report): IPA, 2-propanol
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Administration / exposure

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
Doses / concentrationsopen allclose all
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

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

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

Effect levels (maternal animals)

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

Maternal abnormalities

Key result
Abnormalities:
no effects observed

Results (fetuses)

Effect levels (fetuses)

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

Fetal abnormalities

Key result
Abnormalities:
no effects observed

Overall developmental toxicity

Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
480 mg/kg bw/day (actual dose received)
Treatment related:
no

Applicant's summary and conclusion

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.