Pentan-3-one

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented study; SIDS approved

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

SIDS Dossier ond Butan-2-ol CAS 78-92-2

Author:

US/ICCA

Year:

2002

Bibliographic source:

UNEP Publication of SIAM 14, 26-28 March 2002

Reference 2

Reference Type:

publication

Title:

Studies on the long-term toxicity of 2-butanol.

Author:

Gallo, M.A., Oser, B.L., Cox, G.E., and Bailey, D.E.

Year:

1977

Bibliographic source:

Toxicology and Applied Pharmacology, 41:135 (Abstract).

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)

Deviations:

not specified

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butan-2-ol

EC Number:

201-158-5

EC Name:

Butan-2-ol

Cas Number:

78-92-2

IUPAC Name:

butan-2-ol

Details on test material:

Purity: > or = 99 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

no details

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Details on exposure:

no details

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

8 weeks; 2 generations

Frequency of treatment:

continuously

Details on study schedule:

The F1 generation animals (30/sex/group) were reared to maturity (up to week 12), mated to produce a F2 generation.

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 0.3, 1.0, 3 % (2%)
Basis:
nominal in water

No. of animals per sex per dose:

30

Control animals:

yes, concurrent no treatment

Positive control:

no

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

1

Dose descriptor:

NOAEL

Effect level:

10 000 mg/L drinking water

Sex:

female

2

Dose descriptor:

NOAEL

Effect level:

1 500 mg/kg bw/day

Sex:

female

Basis for effect level:

other: calculated

Results: F1 generation

Details on results (F1)

A series of mild changes in the kidney (non-reactive tubular degeneration, tubular casts, foci of tubular regeneration, microcysts) were observed animals treated at 2.0% butan-2-ol (F2). The authors concluded that these findings were not a result of direct toxicity and did not have clear pathologic significance. Rather they were non-specific effects due to increased renal work load, possibly from increased urine volume and pressure at the high dose of butan-2-ol. No other findings of note were seen.

Effect levels (F1)

1

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

10 000 mg/L drinking water

Sex:

male/female

2

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

1 500 mg/kg bw/day

Sex:

male/female

Basis for effect level:

other: calculated

Overall reproductive toxicity

Reproductive effects observed:

not specified