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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
Beta-pinene
Adequacy of study:
key study
Study period:
The study was conducted in 1975.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The information is used for read across to Rosemarel
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information is based on read across
Justification for type of information:
The full read-across document can be found in the Endpoint Summary in text and in the attached file.
Reason / purpose:
read-across source
GLP compliance:
no
Test type:
other: read across information
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Criteria for classification are not met
Remarks:
according to EU CLP (EC 1272/2008 and its amendments)
Conclusions:
Rosemarel has an LD50 > 5000 mg/kg bw based on read across from Beta-pinene which was tested in a study similar to OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Beta-pinene was administered by gavage at one dose of 5000 mg/kg bw.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males/dose
Control animals:
no
Details on study design:
- Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One rat died on day 7.
Clinical signs:
No symptoms observed.
Body weight:
No information provided.
Gross pathology:
No information provided.
Other findings:
No other findings were noted.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
According to EU CLP 1272/2008 and its amendments.
Conclusions:
The acute oral LD50 for the substance in rats was determined to be greater than 5000 mg/kg bw.
Executive summary:

Acute oral toxicity was performed with Beta-pinene similar to the guideline OECD TG 401. Ten male rats were used and they were administered the substance at the dose of 5000 mg/kg bw. One rat of ten died during the study on day 7. No symptoms in rats were observed. The acute oral LD50 for the substance in rats was determined to be greater than 5000 mg/kg bw.