2-methoxybenzyl alcohol

Repeated dose toxicity: oral

Administrative data

Endpoint:

chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from collection of data.

Data source

Reference

Reference Type:

secondary source

Title:

Comparison of estimated daily intakes of flavouring substances with no-observed-effect levels

Author:

I.C. Munro, B. Danielewska-Nikiel

Year:

2006

Bibliographic source:

Food and Chemical Toxicology 44 (2006) 758–809

Materials and methods

Principles of method if other than guideline:

Benzyl alcohol is the parent compound and p-anisyl acetate is its alkoxy derivate and a metabolite. Based on this correlation, benzyl alcohol has been used as a read across.
Two years toxicity study was conducted to evaluate the chronic toxic nature of the test compound Benzyl alcohol.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl alcohol

EC Number:

202-859-9

EC Name:

Benzyl alcohol

Cas Number:

100-51-6

Molecular formula:

C7H8O

IUPAC Name:

Benzenemethanol

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Benzyl alcohol
- Molecular formula (if other than submission substance): C7-H8-O
- Molecular weight (if other than submission substance): 108.139 g/mol
- Substance type: Organic
- Physical state: No data available

Specific details on test material used for the study:

- Name of test material (as cited in study report): Benzyl alcohol
- Molecular formula (if other than submission substance): C7-H8-O
- Molecular weight (if other than submission substance): 108.139 g/mol
- Substance type: Organic

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No data available

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data available

Duration of treatment / exposure:

2 years

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

0, 200 or 400 mg/Kg bw/day

No. of animals per sex per dose:

No data available

Control animals:

yes, concurrent vehicle

Details on study design:

No data available

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations checked in table [No.?] were included. Mortality was noted

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:

BODY WEIGHT: No data
- Time schedule for examinations:

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

FOOD EFFICIENCY: No data
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data - Time schedule for examinations:

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER: No data

Sacrifice and pathology:

No data available

Other examinations:

No data available

Statistics:

No data available

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

mortality observed, non-treatment-related

Description (incidence):

Mortality: In comparison to controls, a 50% reduction was observed in the survival of female rats at both dose levels; deaths were attributed to gavage error rather than to compound- related toxicity.

Body weight and weight changes:

not specified

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:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Effect levels

Dose descriptor:

NOEL

Effect level:

400 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No adverse effects noted

Remarks on result:

other: No toxic effect observed.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The No Observed Effect Level (NOEL) for the test compound Benzyl alcohol (100-51-6)is considered to be 400 mg/Kg bw/day in rats by oral gavage.

Executive summary:

Two years chronic toxicity study was conducted on rats to evaluate the toxic nature of the test compound Benzyl alcohol. The test substance was exposed to male and female rats at the concentration of 0, 200 or 400 mg/Kg bw/day by oral gavage. The animals were observed for mortality and clinical signs. No significant mortality or clinical sign observed. The No Observed Effect Level (NOEL) for the test compound Benzyl alcohol is considered to be 400 mg/Kg bw/day. Based on the results of the rat study a NOEL of 400 mg/kg body weight/day was selected for the calculation of the margin of safety of Benzyl alcohol