Cypress, Cupressus sempervirens, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1975

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Principles of method if other than guideline:

Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.

GLP compliance:

no

Remarks:

(pre-GLP)

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

Duration of treatment / exposure:

Single treatment (24 h exposure)

Observation period:

14 days

Number of animals:

Total: 10 animals

Details on study design:

No data

Irritation parameter:

other:

Remarks on result:

not determinable because of methodological limitations

Irritant / corrosive response data:

- Mortality was observed in 2/10 animals (first animal died on Day 4 and second animal died on Day 13).
- Slight and moderate redness were observed in 2/10 and 7/10 animals, respectively.
- Moderate oedema was observed in 9/10 animals.

Other effects:

- No other clinical signs were observed

Acute dermal LD50 of test material was higher than 5000 mg/kg bw

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the test conditions, Cypress oil induced slight to moderate skin irritation in rabbits.

Executive summary:

In an acute dermal toxicity study (limit test), ten rabbits were given a single dermal application of Cypress oil at 5000 mg/kg bw. Animals were observed for mortality, clinical signs and local reactions for 14 days.

Mortality was observed in 2/10 animals. Slight and moderate redness were observed in 2/10 and 7/10 animals respectively. Moderate oedema was observed in 9/10 animals. No other clinical signs were observed.

Under the test conditions, Cypress oil induced slight to moderate skin irritation in rabbits.

This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study.

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

- Standard acute method (limit test)

GLP compliance:

no

Remarks:

(pre-GLP)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cypress, Cupressus sempervirens, ext.

EC Number:

283-626-9

EC Name:

Cypress, Cupressus sempervirens, ext.

Cas Number:

84696-07-1

IUPAC Name:

Essential oil of Cupressus Sempervirens (Cupressaceae) obtained from leaves, twigs and fruits by steam distillation

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Cypress oil

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total: 10 animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observation: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1/10 animal was died on Day 1

Mortality:

1/10 animal was died on Day 1.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, oral LD50 of Cypress oil is higher than 5000 mg/kg bw in rats, therefore it is not classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).

Executive summary:

In an acute oral toxicity study (limit test), ten rats were given a single oral dose of Cypress oil at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

1/10 animal was died on Day 1. No clinical signs were observed. In this study, the oral LD50 of Cypress oil was higher than 5000 mg/kg bw in rats.

Under the test conditions, oral LD50 of Cypress oil is higher than 5000 mg/kg bw in rats, therefore it must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (GHS).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.