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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 402 with deviations: no data about test substance purity; no data on source of animals and environmental conditions; bodyweights not recorded.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 402 (Acute Dermal 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 dermal toxicity in a limit test: topical application of substance on rabbits at one dose.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
no data
Doses:
5 mL/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
not needed

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 300 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of terpinolene monoconstituent is higher than 2000 mg/kg bw in rabbits and therefore it is not classified for acute dermal toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
Executive summary:

In an acute dermal toxicity study (similar to OECD Guideline No 402), four rabbits were administered a single dose of terpinolene monoconstituent at 5 mL/kg bw. All animals were observed for mortality and clinical signs of toxicity.

No mortality occurred at the tested dose level. The acute dermal LD50 of terpinolene monoconstituent was considered to be higher than 5 mL/kg bw. As the density of the test item is 0.860 g/cm3, then the LD50 is higher than 4.3 g/kg bw.

The acute dermal LD50 of terpinolene monocostituent is greater than 2000 mg/kg bw in rabbits and therefore it is not classified for acute dermal toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.