Gum turpentine oil, consisting of the volatile fraction resulting from the distillation of oleoresin collected by tapping softwoods from pinacea derivatives (genus: pinus). It consists of terpenes, mainly monoterpenes such as alpha-pinene and beta-pinene.

Eye irritation

Administrative data

Endpoint:

eye irritation: in 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

Materials and methods

Test material

Test material information

Constituent 1

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

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

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

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

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

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

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

- Moderate redness of the conjunctivae associated with moderate to severe chemosis was noted in all treated animals after 1 hour of instillation; irritation completely resolved within 8 days.
- See table 1 for more details

Other effects:

No data

Any other information on results incl. tables

Table 1: Individual and mean scores of conjunctivae, iris and cornea

 

Animal	Time after treatment	Conjunctivae		Iris	Cornea
		Chemosis	Redness	Lesion	Opacity
1	1 hour	2	2	0	0
	24 hours	1	1	0	0
	48 hours	1	1	0	0
	72 hours	2	1	0	0
	Day 4	2	1	0	0
	Day 7	1	1	0	0
	Day 8	0	0	0	0
	Mean (24, 48 and 72 hours)	1.3	1	0	0
2	1 hour	3	2	0	0
	24 hours	2	1	0	0
	48 hours	1	1	0	0
	72 hours	0	1	0	0
	Day 4	0	0	0	0
	Mean (24, 48 and 72 hours)	1	1	0	0
3	1 hour	3	2	0	0
	24 hours	2	2	0	0
	48 hours	1	2	0	0
	72 hours	0	2	0	0
	Day 4	0	1	0	0
	Day 7	0	0	0	0
	Mean (24, 48 and 72 hours)	1	2	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

beta-Pinene is not classified as irritating to eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.

Executive summary:

In an eye irritation study conducted according to OECD Guideline 405 and in compliance with GLP, three male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted beta-pinene in one of the eyes while the other eye corresponded to the control. The eyes were examined for irritation scores at 1 hour and 1, 2, 3, 4, 7 and 8 days after dosing.

 

Instillation of beta-pinene resulted in moderate redness of the conjunctivae associated with moderate to severe chemosis in all treated animals after 1 hour of instillation. The irritation completely resolved within 8 days. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 1, 1, 2 for conjunctivae score and 1.3, 1, 1 for chemosis score.

 

Therefore, beta-pinene is not classified as irritating to eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.