p-mentha-1,4(8)-diene

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: Study performed similarly to OECD Guideline No 401 with deviations: no data about test substance purity; no data on source of animals and environmental conditions; bodyweights not recorded.

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No data about test substance purity; no data on source of animals and environmental conditions; bodyweights not recorded

Principles of method if other than guideline:

Method according to the typical testing for acute oral toxicity: 10 animals/dose by oral gavage.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-mentha-1,4(8)-diene

EC Number:

209-578-0

EC Name:

p-mentha-1,4(8)-diene

Cas Number:

586-62-9

Molecular formula:

C10H16

IUPAC Name:

4-isopropylidene-1-methylcyclohexene

Details on test material:

Name of the test item (as cited in the study report): terpinolene
Label: EOA # 75-132

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

none

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

none

Doses:

3, 3.5, 4 and 5 mL/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

Animals were observed for mortality and clinical signs of toxicity for 14 days.

Statistics:

no data

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4.39 mL/kg bw

Based on:

test mat.

Mortality:

see table 1

Clinical signs:

other: no

Gross pathology:

no data

Other findings:

none

Any other information on results incl. tables

Table 1: number of deaths/dose

Dose (mL/kg bw)	Deaths/number of animals
3.0	0/10
3.5	1/10
4.0	5/10
5.0	6/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for terpinolene monoconstituent is 4.39 mL/kg bw in rats, corresponding to about 3.74 g/kg bw, therefore it is not classified for acute oral toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.

Executive summary:

In an acute oral toxicity study (similar to OECD Guideline No 401), 10 rats/dose were given a single oral dose of terpinolene monoconstituent at 3.0, 3.5, 4.0 and 5.0 mL/kg bw. Animals were then observed for mortality and clinical signs of toxicity. No clinical signs were observed. Deaths occured at 3.5 mL/kg bw and above.

 

The oral LD₅₀ for terpinolene monoconstituent is 4.39 mL/kg bw in rats, corresponding to about 3.74 g/kg bw, therefore it is not classified for acute oral toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.