Tridecan-1-ol

Endpoint summary

Description of key information

Repeated dose toxicity: via oral route

In a subacute Toxicity study Wistar (Alderley Park derived)) male rats were treated with the given test chemical at the concentration of 0 and 184 mg/kg bw/day orally by gavage for14 days.No effect on body weight 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 for14 days. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

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.

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

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

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

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

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

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.

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

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

Critical effects observed:

not specified

Treatment related:

not specified

Dose response relationship:

not specified

Relevant for humans:

not specified

LIVER HISTOLOGY (INCIDENCE OF HISTOLOGICAL ABNORMALITY)

Compound(1 .O mM/kg)	Slight centrilobular hypertrophy	Slight/moderate glycogen vacuolation	Slight/moderate centrilobular ‘fat’ vacuolation
PEG300^a	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
PEG300^a		118(8)	5.21 (0..26)	1.00(0.004)
Tridecanol	184	110 (14)	5.73 (0.26)	1.05 (0.05)

 

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. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

184 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

K2 reliability experimental data

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated dose toxicity: via oral route

Experimental study was reviewed to determine the toxic nature of the test chemical upon repeated exposure by oral route. The study is as mentioned below:

The study was conducted to evaluate the toxic nature of the given test chemical. Repeated dose oral study for 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 oralgavage . 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 standard histopathological 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 for14 days. 

 

Repeated inhalation study:

According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical, which is reported as 0.0099 kPa at temperature 101 Deg C & 101.324 kPa at temperature 280.45 Deg C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron to 53micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

Repeated dermal study:

The acute toxicity value for the given test chemical (as provided in section 7.2.3) is >2600 mg/kg body weight. The OECD study result for acute toxicity by the dermal indicates the LD50 value to be greater than 2000 mg/kg body weight. In addition, the skin sensitization also indicates negative skin sensitization potential by the chemical. Also considering the use of the chemical as a fragrance chemical and considering the volatility absorption by the dermal route is not considered to be significant. Thus, given the above considerations, it is assumed that Tridecanol shall not exhibit repeated dose toxicity by the dermal route.. Therefore this study is considered for waiver.

 

 

Based on the data available for the test chemical and above annotation, the given test chemical does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Thus based on the above annotation for the test chemical and CLP criteria, the given test chemical does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.