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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Alpha-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on alpha-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across source

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
(+)-pin-2(3)-ene
EC Number:
232-087-8
EC Name:
(+)-pin-2(3)-ene
Cas Number:
7785-70-8
Molecular formula:
C10H16
IUPAC Name:
(1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
Constituent 2
Chemical structure
Reference substance name:
(-)-pin-2(3)-ene
EC Number:
232-077-3
EC Name:
(-)-pin-2(3)-ene
Cas Number:
7785-26-4
Molecular formula:
C10H16
IUPAC Name:
(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
impurity 1
Chemical structure
Reference substance name:
(1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
EC Number:
227-336-2
EC Name:
(1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
Cas Number:
5794-03-6
Molecular formula:
C10H16
IUPAC Name:
(1R,4S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
impurity 2
Chemical structure
Reference substance name:
(1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
EC Number:
227-337-8
EC Name:
(1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
Cas Number:
5794-04-7
Molecular formula:
C10H16
IUPAC Name:
(1S,4R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
impurity 3
Chemical structure
Reference substance name:
(-)-pin-2(10)-ene
EC Number:
242-060-2
EC Name:
(-)-pin-2(10)-ene
Cas Number:
18172-67-3
Molecular formula:
C10H16
IUPAC Name:
(1S,5S)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
impurity 4
Chemical structure
Reference substance name:
1,7,7-trimethyltricyclo[2.2.1.02,6]heptane
EC Number:
208-083-7
EC Name:
1,7,7-trimethyltricyclo[2.2.1.02,6]heptane
Cas Number:
508-32-7
Molecular formula:
C10H16
IUPAC Name:
1,7,7-trimethyltricyclo[2.2.1.0~2,6~]heptane
impurity 5
Chemical structure
Reference substance name:
7,7-dimethyl-2-methylene-(1R,4S)-bicyclo[2.2.1]heptane
Cas Number:
116724-26-6
Molecular formula:
C10H16
IUPAC Name:
7,7-dimethyl-2-methylene-(1R,4S)-bicyclo[2.2.1]heptane
impurity 6
Chemical structure
Reference substance name:
7,7-dimethyl-2-methylene-, (1S,4R)-bicyclo[2.2.1]heptane
Cas Number:
7378-37-2
Molecular formula:
C10H16
IUPAC Name:
7,7-dimethyl-2-methylene-, (1S,4R)-bicyclo[2.2.1]heptane
impurity 7
Chemical structure
Reference substance name:
(1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
Cas Number:
19902-08-0
Molecular formula:
C10H16
IUPAC Name:
(1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
Test material form:
liquid
Details on test material:
Batch No. : FAB-29062016
Purity : 96.2% (sum of the two main constituents)
Name of test material (as cited in study report): alpha-pinene multiconstituent
Physical state: colourless liquid
Storage Conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry Date: 28 June 2017

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
other: No systemic clinical signs related to the administration of the test item were observed. Cutaneous reactions (erythema and dryness) were noted in all animals (10/10) at 24 h post-dose and were totally reversible on day 13.
Gross pathology:
No macroscopic abnormalities were observed at necropsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of alpha-pinene multiconstituent is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) n° 1272/2008 and UN GHS.
Executive summary:

In an acute dermal toxicity study performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex/dose) was given a single dermal application of alpha-pinene multiconstituent at 2000 mg/kg bw. The test item was applied on dorsal area of the trunk representing approximately 10% of the total body surface area of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. Cutaneous reactions (erythema and dryness) were noted in all animals (10/10) at 24-hour post-dose and were totally reversible on day 13. Body weight gain of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment-related changes.

In conclusion, the LD50 of test item alpha-pinene multiconstituent is higher than 2000 mg/kg body weight by dermal route in the rat. Test item alpha-pinene multiconstituent does not have to be classified in accordance with Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures and UN GHS.