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Toxicological information

Toxicity to reproduction

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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

Referenceopen allclose all

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 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

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)

open allclose all
Dose descriptor:
NOAEL
Effect level:
10 000 mg/L drinking water
Sex:
female
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)

open allclose all
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
10 000 mg/L drinking water
Sex:
male/female
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

Applicant's summary and conclusion