Fir, Abies sibirica, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

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:

1976

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 details

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

- Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively.
- Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.

Other effects:

- No mortality was observed.

None

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the test conditions, Abies Sibirica Oil induced slight to moderate skin irritation in rabbits.

Executive summary:

In an acute dermal toxicity study, ten rabbits were topically applied with a single dose of Abies Sibirica Oil at 5000 mg/kg bw. All animals were observed for mortality, clinical signs and local reactions.

No mortality occurred at the tested dose level. Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively. Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.

Under the test conditions, Abies Sibirica 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 of 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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

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:

Fir, Abies sibirica, ext.

EC Number:

294-351-9

EC Name:

Fir, Abies sibirica, ext.

Cas Number:

91697-89-1

Molecular formula:

not applicable

IUPAC Name:

Essential oil of Abies sibirica Ledeb. (Pinaceae) obtained from needles and branches by distillation.

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Abies Sibirica 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 details

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total: 10 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 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:

None

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: No mortality was observed

Mortality:

- No mortality was observed.

Clinical signs:

- Slightly flaccid muscle tone was observed on Day 1
- Diarrhea and ptosis were observed in some animals from Days 1-3.

Body weight:

No data

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, the oral LD50 for test item 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).

Executive summary:

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

No mortality was observed. Slightly flaccid muscle tone was observed on Day 1. Diarrhea and ptosis were observed in some animals from Days 1-3. In this study, the oral LD50 of Abies Sibirica Oil was higher than 5000 mg/kg bw in rats.

Under the test conditions, oral LD50 of Abies Sibirica Oil is higher than 5000 mg/kg bw in rats therefore it is not classified according 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.