Terpene

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

6 to 7 weeks old

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

single dose at 2000mg/kg

Control animals:

yes

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Clinical signs:

other: No abnormalities observed

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Food availability: Ad libitum
Drinking water: Tap water
Watering: Bottles
Quality control: Certificate of analysis will be included in the final report
Water availability: Ad libitum

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

Oxygen concentration in the exposure chamber will be at least 19% and carbon dioxide will not exceed 1%.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gravimetric determination of the aerosol concentration

Duration of exposure:

ca. 4 h

No. of animals per sex per dose:

6 animals for the first step (3 males and 3 females) and 2 spare animals. Each additional step will contain 3 males and 3 females.

Control animals:

yes

Details on study design:

- Observation period of at least 14 days
- Frequency of observations and weighing: No diet or drinking water will be available during exposure.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

ca. 10 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Clinical signs:

other:

Interpretation of results:

Category 3 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

10 000 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available