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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
August to November 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octyldodecan-1-ol
EC Number:
226-242-9
EC Name:
2-octyldodecan-1-ol
Cas Number:
5333-42-6
Molecular formula:
C20H42O
IUPAC Name:
2-Octyldodecan-1-ol

Test animals

Species:
rat
Strain:
CD-1
Details on test animals or test system and environmental conditions:
According to guidelineTEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean weight 196 g
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 38-58
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: September 30 to November 4, 1992

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on exposure:
Test substance was administered orally by gavage once daily in the morning from day 6 up tp day 15 post coitum inclusive. All groups received a dose volume of 5ml/kg body weight, adjusted to the body weight of day 6 post coitum. Control animals were similarly dosed with the vehicle alone.
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
According to guideline.
Duration of treatment / exposure:
day 6 to day 15 of gestation.
Frequency of treatment:
daily
Duration of test:
until day 20 of gestation.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Remarks:
Group 1 (Control group)
Dose / conc.:
100 mg/kg bw/day
Remarks:
Group 2 (Low dose, actual ingested)
Dose / conc.:
300 mg/kg bw/day
Remarks:
Group 3 (Mid dose, actual ingested)
Dose / conc.:
1 000 mg/kg bw/day
Remarks:
Group 4 (High dose, actual ingested)
No. of animals per sex per dose:
24
Control animals:
yes
Details on study design:
none

Examinations

Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
POST-MORTEM EXAMINATIONS: Yes
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes :
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
Fetal examinations:
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter
Statistics:
yes
Historical control data:
no

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
no effects observed
Changes in number of pregnant:
no effects observed
Other effects:
no effects observed
Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Remarks on result:
other: No maternal toxicity was observed at all tested doses.

Maternal abnormalities

Key result
Abnormalities:
not specified

Results (fetuses)

Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
no effects observed
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
Group 1: no variations
Group 2: ribs rudimentary unilateral/bilateral, significant decrease at level 1%, thoracic vertebrae, dumbbell shape, significant increase at level 5%
Group 3: no variations
Group 4: thoratic vertebrae, dumbell shape, significant increase at level 1%

The statistical significant differences were considered to be incidental. The findings in the ribs rudimentare are due to the increase of the control group. The other variation effects to the thoratic vertebrae, dumbell shape are also incidental and not dose-related. The incidental character of these variations is emphasized by the fact that the values were within the normal range of variations for this strain.
Visceral malformations:
no effects observed
Other effects:
no effects observed
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

open allclose all
Key result
Dose descriptor:
NOEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: embryotoxicity
Remarks on result:
other: No effects were observed at all tested doses.
Key result
Dose descriptor:
NOEL
Effect level:
> 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: fetotoxicity
Remarks on result:
other: No effects were observed at all tested doses.

Fetal abnormalities

Key result
Abnormalities:
not specified

Overall developmental toxicity

Key result
Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the NOAEL for maternal systemic toxicity and developmental toxicity was up to 1000 mg /kg bw/day, as no effects were observed at all tested doses.
Executive summary:

In a developmental toxicity study conducted according to the OECD guideline No. 414 and in compliance with GLP, 2 -octyl-1 -dodecanol diluted in arachis oil was administered to 24 females rats/dose by gavage at dose levels of 0, 100, 300 or 1000 mg/kg bw/day from days 6 through 15 of gestation.

 

All animals were observed twice daily for appearance and behavior. The uteri and ovaries were examined, and the number of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Gravid uterine weights were recorded, and net body weights and net body weight changes were calculated. The fetuses were weighted, sexed and examined for external, visceral and skeletal malformations and developmental variation.

 

All animals survived to the scheduled necropsy. No maternal effects were observed in all tested doses.

There were no test article-related internal findings at the scheduled necropsy. For the effect on fetuses, no significant changes were observed in the number of live fetuses, embryo/fetal mortality, sex ratio, body weight of live fetuses, or in the external, visceral, or skeletal examination of fetuses, at all tested animals. No test article-related fetal malformations or developmental variations were noted at any dose level in this study. No other signs of developmental toxicity were noted.

Based on the results of this study, the dose level up to 1000 mg/kg bw/day was considered to be the NOAEL(systemic effects) for maternal toxicity and the NOAEL for developmental toxicity.

Under the test conditions, the test substanceis not classified according to Regulation (EC) No.1272/2008 (CLP) criteria.

This study is acceptable and satisfies the requirement for developmental toxicity endpoint.