Carvacrol

Endpoint summary

Description of key information

Acute Oral Toxicity: LD50 (male/female) is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw. (Similar to OECD 401)

Acute Inhalational Toxicity: This endpoint is waived as the substance is classified as Skin corrosive Category 1B/C.

Acute Dermal Toxicity: This endpoint is waived as the substance is classified as Skin corrosive Category 1B/C.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Fasting period before study: 18 hr prior to treatment
- Diet: Food was replaced in cages as soon as animals received their respective doses
- Water: ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

No data

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks.

Statistics:

The LD50's, slope function, and their confidence limits were recorded. LD50'S were computed by the method of Litchfield & Wilcoxon.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

810 mg/kg bw

95% CL:

> 710 - < 920

Mortality:

Death within 1 hour to 3 days

Clinical signs:

other: Depression within 10 min, coma within 1 hour.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 for acute oral toxicity of Carvacrol in Osborne-Mendel rats is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw.

Executive summary:

In an acute oral toxicity study similar to OECD 401 (Jenner, 1964), Osborne Mendel rats (5/dose/sex) were given Carvacrol and observed for 14 days.

Deaths occurred between 1 hr and 3 days. Depression was evident within 10 mins and coma within 1 hour.

The LD50 (male/female) is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

810 mg/kg bw

Quality of whole database:

The key study was the only study available and was assigned a Klimisch score of 2. The overall quality of the database is high

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is one acute oral toxicity study available in rats. Acute inhalation and dermal toxicity are wavied as the substance is classified as skin corrosive Category 1B/C.

In an acute oral toxicity study similar to OECD 401, Osborne Mendel rats (5/dose/sex) were given Carvacrol and observed for 14 days. Deaths occurred between 1 hr and 3 days. Depression was evident within 10 mins and coma within 1 hour. The LD50 (male/female) is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw.

The results from this study are acceptable to use in the human health risk assessment.

 

Justification for classification or non-classification

Based on the available information in the dossier, the substance Carvacrol (CAS No. 499-75-2) should be classified for Acute Oral Toxicity Category 4 when the criteria outlined in Annex I of 1272/2008/EC are applied.