Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The Absence Of Testicular Atrophy And In Vivo And In Vitro Effects On Hepatocyte Morphology And Peroxisomal Enzyme Activities In Male Rats Following The Administration Of Several Alkanols
Author:
C. Rhodes et.al.
Year:
1984
Bibliographic source:
Toxicology Letters, (1984)
Reference Type:
secondary source
Title:
IUCLID Data Set
Author:
OECD
Year:
2006
Bibliographic source:
OECD SIDS, 2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the toxic potential of test chemical in male Wistar rats by subacute study.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation (if other than submission substance): C(CCCCCCO)CCCCCC
- InChl (if other than submission substance): 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-TRIDECANOL
- Common name : tridecan-1-ol
- Molecular formula : C13H28O
- Molecular weight : 200.37 g/mol
- Smiles notation : C(CCCCCCO)CCCCCC
- InChl : 1S/C13H28O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h14H,2-13H2,1H3
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Alderley Park
- Age at study initiation: Not specified
- Fasting period before study: Not specified
- Housing: Animals were housed singly in steel, screen-bottomed cages.
- Diet (e.g. ad libitum): Food , ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
300
Details on oral exposure:
Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: Tridecan-1-ol were administered at a dose level equivalent to 1 mmol/kg/day dissolved in polyethylene glycol300 (10 ml/kg/day).

VEHICLE
- Justification for use and choice of vehicle (if other than water): Polyethylene glycol 300
- Concentration in vehicle: 0 and 184 mg/kg bw
- Amount of vehicle (if gavage): 10 ml/kg/day
- Lot/batch no. (if required):
- Purity:
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
Every morning for 14 days
Doses / concentrations
Remarks:
0 and 184 mg/kg bw/day
No. of animals per sex per dose:
Total:
0 mg/kg bw: 10 male
184 mg/kg bw: 5 male
Control animals:
yes, concurrent vehicle
Details on study design:
Not specified
Positive control:
Not specified

Examinations

Observations and examinations performed and frequency:
Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes


CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: After necropsy blood was withdrawn by cardiac puncture.

- Animals fasted: Yes / No / No data
- How many animals: 5 animals
- Parameters checked in table [No.?] were examined. Animals were assayed for plasma Cholesterol (Gilford 3500 analyser, BCL test kit 237574) and plasma triglyceride.


Other;
Organ weight; Liver and testes weight were observed in all five animals.
Sacrifice and pathology:
Sacrifice and pathology
GROSS PATHOLOGY: Yes, Animals were killed by halothane overdose. Liver and testes were observed.
HISTOPATHOLOGY: Yes , The liver was removed,
weighed and samples taken for light and electron microscopy using standard histopathological procedures. Morphometric analysis of electron micrographs was
made by the method of Weibel et al.
Other examinations:
IN VITRO culture with rat Hepatocytes was performed to analyze hepatic enzyme.
Statistics:
Mean ± Standard deviation was observed.

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No statistically significant effect were observed at dose level 184 mg/kg/day of treated group compare to control.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
No statistically significant effect were observed at dose level 184 mg/kg/day of treated group compare to control.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
No statistically significant effect were observed at dose level 184 mg/kg/day of treated group compare to control.
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No statistically significant effect were observed at dose level 184 mg/kg/day of treated group compare to control.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
184 other: mg/kg/day
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No effect on body weight, Clinical chemistry, organ weight and histopathology
Remarks on result:
other: No toxic effect observed

Target system / organ toxicity

Critical effects observed:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Any other information on results incl. tables

LIVER HISTOLOGY (INCIDENCE OF HISTOLOGICAL ABNORMALITY)

Compound(1 .O mM/kg)

Slight centrilobular hypertrophy

Slight/moderate glycogen vacuolation

Slight/moderate centrilobular

‘fat’ vacuolation

PEG300a

4

9

6

Tridecanol

 

2

4

2

 

a10 rats per control group (10 ml/kg/day).

b5 rats used per test group.

 

The effect of plasticizer alcohols on body weight gain and liver and testis weight to bodyweight ratio in male rats following oral administration

AT 1 mmol/kg/DAY FOR 14 DAYS

(Mean ±SD; Control n= 10; tests n= 5.)

Sample

Mg/kg/day

Body weight gain

Liver:b.w.t. ratio x 100

Testis:b.w.t.

ratio x 100

 

PEG300a

 

118(8)

5.21 (0..26)

1.00(0.004)

Tridecanol

 

184

110 (14)

5.73 (0.26)

 1.05 (0.05)

 

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 184 mg/kg bw/day for Wistar (Alderley Park derived)) male rats, when they were treated with test chemical orally by gavage for 14 days.
Executive summary:

Repeated dose oral study for the given test chemical was assessed for its possible toxic potential. For this purpose Sub acute study for 14 days was conducted on Wistar (Alderley Park derived)) male rats. The test material was exposed at the concentration of 0, and 184 mg/kg bw by oral gavage . Animals received the test substance by oral gavage every morning for 14 days. The animal’s body weight, were recorded. days. Animals were killed by halothane overdose and blood was withdrawn by cardiac puncture, and assayed for plasma cholesterol and plasma triglyceride. The liver was removed,weighed and samples taken for light and electron microscopy using standardhistopathological procedures. Morphometric analysis of electron micrographs was made by the method of Weibel et al. No effect on bodyweight gain and clinical chemistry were observed in treated male rats compared to control. In addition, No effect on liver and Testis weight and histopathology were also observed in treated male rats as compared to control. Therefore, NOAEL was considered to be 184 mg/kg bw /day for (Wistar Alderley Park derived) male rats when they were treated with test chemical orally by gavage for 14 days.