Alcohols, C7-9

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Research publication, study well documented, meets generally accepted scientific principles, acceptable for assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Research study to determine the effects of the test material on testis weight as an indication of testicular atrophy, in which male rats were given 128 mg/kg bw/day by gavage for 14 days.

GLP compliance:

not specified

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C6-12

EC Number:

271-642-9

EC Name:

Alcohols, C6-12

Cas Number:

68603-15-6

IUPAC Name:

octan-1-ol

Details on test material:

- Name of test material (as cited in study report): Linevol 79, C6-12 alcohols Type C
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ICI
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: individually in steel, screen-bottomed cages

- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on exposure:

PREPARATION OF DOSING SOLUTIONS: test substance dissolved in polyethylene glycol 300

VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Concentration in vehicle: 12.8 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw/day

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

14 days

Frequency of treatment:

daily

Duration of test:

14 days

Doses / concentrations

Remarks:

Doses / Concentrations:
1 mmol/kg bw/day (128 mg/kg bw/day)
Basis:
actual ingested

No. of animals per sex per dose:

5 males in treatment group
10 males in control group

Control animals:

yes, concurrent vehicle

Details on study design:

Male rats given 128 mg/kg bw/day of the test material by oral gavage for 14 days. At study termination the testes were weighed and the testis weight:body weight ratio determined.

Statistics:

none

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

128 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male

Basis for effect level:

other: only one dose level tested; no effect on testis weight (relative to body weight)

Observed effects

No differences in testis weight (relative to body weight) were evident in the treated group compared to the control group. There were no deaths during the study and no clinical signs of toxicity were reported. However, it is usual to evaluate absolute testis weight (rather than relative to body weight) and no such data were presented.

Any other information on results incl. tables

Following repeated oral administration of equimolar dose levels of various alkanols to male rats for a period of 14 days there were no statistically significant differences in body weight gain, or relative liver or testes weights.

Applicant's summary and conclusion

Conclusions:

In a reliable study, conducted to determine the effects of Linevol 79 (C6-12 alcohols Type C) on the testis, 128 mg/kg bw/day did not change the testis weight:body weight ratio, measured as an indicator of testicular atrophy. For the endpoint evaluated, an NOAEL of 128 mg/kg bw/day was identified, but absolute testis weights were not presented.