Pine, Pinus mugo, 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

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

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:

Pine, Pinus mugo, ext.

EC Number:

290-163-6

EC Name:

Pine, Pinus mugo, ext.

Cas Number:

90082-72-7

Molecular formula:

UVCB substance - no molecular formula available.

IUPAC Name:

Pine, Pinus mugo, ext.

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Pinus Oil Pumilio

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:

unchanged (no vehicle)

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:

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: No mortality was observed.

Mortality:

- No mortality was observed.

Clinical signs:

- No clinical signs were observed.

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, oral LD50 of Pinus Oil Pumilio 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 Pinus Oil Pumilio at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.

No mortality and clinical signs were observed. In this study, the oral LD50 of Pinus Oil Pumilio was higher than 5000 mg/kg bw in rats.

Under the test conditions, oral LD50 of Pinus Oil Pumilio 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.