Product obtained by rectification during the manufacturing process of Dihydromyrcenol

Endpoint summary

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

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:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 452 (Chronic Toxicity Studies)

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

16 weeks

Frequency of treatment:

animals had unlimited access to food

Remarks:

Doses / Concentrations:
10000 ppm
Basis:
actual ingested

No. of animals per sex per dose:

10

Control animals:

yes

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes. food at all times

FOOD EFFICIENCY: no data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes, water at all times

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes, white cell counts, red cell counts, haemoglobins and haemotocrits were measured at the end of the experiment

CLINICAL CHEMISTRY: No data

URINALYSIS: No data

NEUROBEHAVIOURAL EXAMINATION: No data

ORGAN WEIGHTS: yes: lives, kidneys, spleen heart, and testes

GROSS PATHOLOGY: no data

HISTOPATHOLOGY: non-neoplastic: Liver

HISTOPATHOLOGY: neoplastic: no effects

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

Liver: microscopic- slight hydropic changes of hepatic cells in males only

Mortality:

mortality observed, treatment-related

Description (incidence):

Liver: microscopic- slight hydropic changes of hepatic cells in males only

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

no effects observed

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:

not specified

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Description (incidence and severity):

Liver: microscopic- slight hydropic changes of hepatic cells in males only

Histopathological findings: neoplastic:

no effects observed

Dose descriptor:

NOAEL

Effect level:

ca. 10 000 ppm

Based on:

act. ingr.

Sex:

male/female

Basis for effect level:

other: Liver: microscopic- slight hydropic changes of hepatic cells in males only

Critical effects observed:

not specified

Conclusions:

The substance is not considered as toxic by repeated doses as only slight hydropic changes of hepatic cells in males only are produced by its action.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

10 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the criteria outlined in Regulation (EC) No. 1272/2008 and taking into account the source information of E-(anethole), Terpene does not have to be classified with regard to repeated toxicity.