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Toxicological information

Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
29 May 1998 to 26 June 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, performed according to international guidelines, but reproductive toxicity data limited to examination of the testis only
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Deviations:
yes
Remarks:
(no functional observations; limited pathological examniation)
GLP compliance:
yes (incl. certificate)
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Referenced in historical documentation (ICCA/OECD HPV) as Alcohols, C10-16 / 67762-41-8, compositional Type B

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 5 weeks
- Weight at study initiation: males, 144.2-171.6 g (mean 159.3 g); females, 114.4-134.8 g (124.7 g)
- Fasting period before study: no data
- Housing: in groups of 5 in stainless steel cages with mesh floors
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-25.0
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29-May-1998 To: 26-Jun-1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: prepared in corn oil; concentration adjusted to give a constant dosing volume of 5 ml/kg bw. Twice per week the dose volumes were adjusted to the latest body weight of each individual animal. Fresh dosing solutions were prepared weekly.

VEHICLE
- Justification for use and choice of vehicle (if other than water): no data
- Concentration in vehicle: 0, 20, 60 or 200 mg/ml
- Amount of vehicle (if gavage): 5 ml/kg bw
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
The concentrations of the test material in corn oil were analysed using a Perkin Elmer 8700 gas chromatograph with flame ionisation detection on day of preparation and after 7 days storage in a refrigerator.
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily (7 days/week)
Duration of test:
28 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300 or 1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
5 males/dose
Control animals:
yes, concurrent vehicle
Details on study design:
Groups of 5 male rats were treated daily with the test material for 28 days. At study termination body weights and testis weights were recorded. The testes were examined macroscopically and microscopically for abnormalities.
Statistics:
Body weights: one -way analysis of covariance (covariate body wt day 0) followed by Dunnetts multiple comparision tests
Histopathology: Fishers exact probability test.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No changes in absolute or relative testis weights and no histopathological abnormalities at any dose tested

Observed effects

There were no differences in absolute or relative testis weights and no evidence of testicular abnormalities on macro- or microscopic examination. Body weights in the high-dose group were reduced compared to the control group.

Applicant's summary and conclusion

Conclusions:
In a reliable study performed to OECD guideline 407, Compound 33A (a mixture of C12-C13 alcohols) administered by gavage to male rats at up to 1000 mg/kg bw/day for 28 days, had no affect on the absolute or relative weight of the testis and no abnormalities were evident on microscopic examination of the testes. The study was performed to GLP.