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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Beta-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on beta-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(10)-ene
EC Number:
204-872-5
EC Name:
Pin-2(10)-ene
Cas Number:
127-91-3
Molecular formula:
C10H16
IUPAC Name:
6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
impurity 1
Chemical structure
Reference substance name:
p-mentha-1(7),2-diene
EC Number:
209-081-9
EC Name:
p-mentha-1(7),2-diene
Cas Number:
555-10-2
Molecular formula:
C10H16
IUPAC Name:
3-isopropyl-6-methylenecyclohexene
impurity 2
Chemical structure
Reference substance name:
7-methyl-3-methyleneocta-1,6-diene
EC Number:
204-622-5
EC Name:
7-methyl-3-methyleneocta-1,6-diene
Cas Number:
123-35-3
Molecular formula:
C10H16
IUPAC Name:
7-methyl-3-methyleneocta-1,6-diene
impurity 3
Chemical structure
Reference substance name:
Pin-2(3)-ene
EC Number:
201-291-9
EC Name:
Pin-2(3)-ene
Cas Number:
80-56-8
Molecular formula:
C10H16
IUPAC Name:
2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
impurity 4
Chemical structure
Reference substance name:
Dipentene
EC Number:
205-341-0
EC Name:
Dipentene
Cas Number:
138-86-3
Molecular formula:
C10H16
IUPAC Name:
4-isopropenyl-1-methylcyclohexene
impurity 5
Chemical structure
Reference substance name:
Camphene
EC Number:
201-234-8
EC Name:
Camphene
Cas Number:
79-92-5
Molecular formula:
C10H16
IUPAC Name:
2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
impurity 6
Chemical structure
Reference substance name:
3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
EC Number:
236-719-3
EC Name:
3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
Cas Number:
13466-78-9
Molecular formula:
C10H16
IUPAC Name:
3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
Test material form:
liquid
Details on test material:
Batch No.: EG12R
Purity: 95.8%
Name of test material (as cited in study report): BETA-PINENE
NOTE: Due to an industry habit inherited from the past, the test material was referenced as beta pinene whereas it was actually (-)-beta pinene.
Physical state: Colorless-slightly amber liquid
Storage condition of test material: 6 ± 3 °C, protected from light; kept under nitrogen
Expiration date: April 21, 2011

Test system

Vehicle:
unchanged (no vehicle)

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: viability % (MTT assay)
Value:
38.5
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 min. Reversibility: no data. Remarks: ± 3.5. (migrated information)

Any other information on results incl. tables

Negative control (PBS+): mean OD = 0.821

Positive control (5% SDS): % viability (MTT assay) = 18.7 ± 3.0

Test item: % viability (MTT assay) = 38.5 ± 3.5

Table 1: MTT conversion assay in living epidermis

 

 

O.D. 1

O.D. 2

Mean

Standard deviation

Viability %

Mean Viability %

Standard deviation

Negative control

Epidermis 1

0.768

0.808

0.788

0.028

96.0

100

0.044

Epidermis 2

0.855

0.864

0.860

0.006

104.7

Epidermis 3

0.819

0.811

0.815

0.006

99.3

Positive control

Epidermis 1

0.124

0.145

0.135

0.015

16.4

18.7

0.030

Epidermis 2

0.158

0.131

0.145

0.019

17.6

Epidermis 3

0.191

0.172

0.182

0.013

22.1

Test item

Epidermis 1

0.359

0.293

0.326

0.047

39.7

38.5

0.035

Epidermis 2

0.301

0.267

0.284

0.024

34.6

Epidermis 3

0.358

0.318

0.338

0.028

41.2

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The percentage of viability is ≤ 50% and (-)-beta-pinene is classified as irritating to skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
Executive summary:

An in vitro GLP study conducted with human epidermis model EPISKIN was performed to assess the irritancy potential of (-)-beta-pinene similarly to ECVAM protocol version 1.8 of February 2009. 10 µL of the test item was applied directly on 3 epidermis for 15 min. Positive control was 10 µL of 5% (w/v) SDS solution and negative control was 10 µL of PBS (each tested on 3 epidermis). MTT conversion assay was peformed to evaluate the percentage of cellular viability of the epidermis. Positive control had a percentage of cell viability of 18.7± 3.0 and test item had a percentage of cell viability of 38.5 ± 3.5. As the percentage of viability is ≤ 50%, the test item is considered to be irritating for skin.

Therefore, (-)-beta-pinene is classified as irritating to skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) n° 1272/2008.