3-ethoxy-4-hydroxybenzaldehyde

Carcinogenicity

Description of key information

Available studies were poorly detailed, but gave negative results.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity: 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

Remarks:

Few details on the study were available, but body weight gain, haematology, gross patholgy and histopathology on the main organs were realized. The substance purity is unknown and the study was performed before GLP compliance.

Qualifier:

no guideline followed

Principles of method if other than guideline:

repeated chronic study by oral feed in rats and carcinogenicity study.

GLP compliance:

no

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: weanling rats
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: individually in wire cages
- Diet (e.g. ad libitum): free access, quality unspecified
- Water (e.g. ad libitum): free access, quality unspecified
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): fresh diets were made and distributed weekly
- Mixing appropriate amounts with (Type of food): no data
- Storage temperature of food: no data

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

2 years

Frequency of treatment:

daily

Post exposure period:

none

Remarks:

Doses / Concentrations:
5000, 10000 and 20000 ppm (250, 500 and 1000 mg/kg/day)
Basis:
nominal in diet

No. of animals per sex per dose:

12 males and 12 females

Control animals:

yes, plain diet

Details on study design:

- Dose selection rationale: no data
- Rationale for animal assignment (if not random): by weight of weanling rats

Positive control:

no

Observations and examinations performed and frequency:

The rat's weight, food intake and general condition were recorded every week.

CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): weekly

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: At termination, and at 3, 6, 12 and 22 months.
These examinations included white cell counts, red cell counts, haemoglobins and hematocrits.

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes: liver, kidneys, spleen, heart and testes
HISTOPATHOLOGY: Yes: on tissues described above, and one hind leg for bone, bone marrow and muscle.

Statistics:

no data

Clinical signs:

no effects observed

Mortality:

no mortality observed

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:

no effects observed

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

No more informations that no effects (neoplastic and non-neoplastic effects) at 5000, 10000 and 20000 ppm (respectively 250, 500 and 1000 mg/kg/day).
Based on this study, no carcinogenic effects were observed in rats after 2 years of exposure.

Relevance of carcinogenic effects / potential:

Negative.

Key result

Dose descriptor:

NOAEL

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: overall effects

Remarks on result:

not determinable

Remarks:

no NOAEL identified. Effect type: carcinogenicity

Conclusions:

Based on this study, no carcinogenic effects were observed in rats after 2 years of exposure.

Executive summary:

In the study of Hagan (1967), rats (12 males and 12 females per group) were exposed by feeding for 2 years to 5000,10000 and 20000 ppm (250, 500 and 1000 mg/kg/day). Only few results were reported with no details, it appears no effect (general and carcinogenic effects) for all the doses tested.

Despite the fact that only few results were reported, this study shows that ethylvanillin has low toxicity and carcinogenic effects were not expected.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Two studies were available, one performed by oral route with reliability 2 according to Klimisch (Hagan, 1967) and another one conducted by i.p. with reliability 4 (Stoner, 1973).

These studies were poorly described, but gave negative results.

Based on the first study with reliability 2 and performed by oral route (selected as key study), ethylvanillin appears to have low toxicity and carcinogenic effects were not expected even if all the organs were not examined.