Registration Dossier

Based on based on animal test data read-across from Oct-1 -ene and HOPA category members, Oct-2 -ene is not anticipated to be irritating to skin or eye irritating.

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read-across between the target substance Oct-2-ene (EC 203-894-2 / CAS 111-67-1) and source substances Octene (EC 246-920-8 / CAS 25377-83-7) and Oct-1-ene (EC 203-893-7 / CAS 111-66-0 / alpha-C8) is based upon the similarity of the chemical structures and their respective physico-chemical properties. The ECHA Read-Across Assessment Framework (RAAF) states that substances with qualitatively similar properties can form the basis of read-across in circumstances where the source and target substances share such similar characteristics.

Octene, Oct-1-ene and Oct-2-ene are linear olefins, each with a carbon chain length of C8. Structurally, the difference between source and target substances is the position of the carbon-carbon double bond. For Oct-1-ene the double bond is at the terminal C1 position (hence, an alpha-olefin), whereas for Oct-2-ene the double bond is at the non-terminal C2 position (hence, an internal olefin). A comparison of the target and source substance properties shows that all substances would be expected to exhibit similar environmental fate, ecotoxicological and mammalian toxicological behaviours. The justification for read-across from source substances Octene and Oct-1-ene to target substance Oct-2-ene is detailed in section 13 (Document name: “Oct-2-ene Read Across Document HOPA”).

Further, Oct-2-ene and Oct-1-ene both fit within the boundaries of the chemical category of higher olefins. Studies conducted by the HOPA consortium on a large range of higher olefin category members (including Oct-1-ene) demonstrated sufficiently similar physico-chemical, environmental fate and toxicological properties to substantiate the basis for read-across. Therefore Oct-2-ene is expected to behave similarly. Justification for inclusion of Oct-2-ene within the boundaries of the higher olefins category, and the relevance of each category member as an analogue substance to Oct-2-ene, is provided in Section 13 (Document name: “HOPA Higher Olefins CJD with Category Matrix Report [rev 1 Sept 2016]”).

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Number of animals:

6 (5 males, 1 female)

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal: Mean of animals (1-6)

Time point:

24/48/72 h

Score:

ca. 3.42

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal: Mean of animals (1-6)

Time point:

24/48/72 h

Score:

1.9

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal: Mean of animals (1-6)

Time point:

24/48/72 h

Score:

1.1

Reversibility:

not specified

Interpretation of results:

other: Not irritating according to EU CLP classification

Remarks:

Criteria used for interpretation of results: EU

Executive summary:

In a primary dermal irritation study, 5 male and 1 female New Zealand White rabbits were dermally exposed to 0.5 millilitre of Gulftene 8 for 4 hours. Animals then were observed for 14 days and irritation was scored by the Draize method.

The test material application produced a primary irritation index of 3.42 calculated according to US EPA FIFRA guidelines, and mean scores of 1.9 for erythema/eschar formation and 1.1 for edema according to EU labelling restrictions. Compound-induced corrosion was not reported.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out according to Guidelines (EPA 798.4470, OECD 404, 92/69/EEC B.4 and MAFF 59 NohSan No. 4200) and was GLP compliant.

Read-across to Oct-2 -ene is claimed as valid basd on the justifications provided for both analogue and category approaches.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read-across between the target substance Oct-2-ene (EC 203-894-2 / CAS 111-67-1) and source substances Octene (EC 246-920-8 / CAS 25377-83-7) and Oct-1-ene (EC 203-893-7 / CAS 111-66-0 / alpha-C8) is based upon the similarity of the chemical structures and their respective physico-chemical properties. The ECHA Read-Across Assessment Framework (RAAF) states that substances with qualitatively similar properties can form the basis of read-across in circumstances where the source and target substances share such similar characteristics.

Octene, Oct-1-ene and Oct-2-ene are linear olefins, each with a carbon chain length of C8. Structurally, the difference between source and target substances is the position of the carbon-carbon double bond. For Oct-1-ene the double bond is at the terminal C1 position (hence, an alpha-olefin), whereas for Oct-2-ene the double bond is at the non-terminal C2 position (hence, an internal olefin). A comparison of the target and source substance properties shows that all substances would be expected to exhibit similar environmental fate, ecotoxicological and mammalian toxicological behaviours. The justification for read-across from source substances Octene and Oct-1-ene to target substance Oct-2-ene is detailed in section 13 (Document name: “Oct-2-ene Read Across Document HOPA”).

Further, Oct-2-ene and Oct-1-ene both fit within the boundaries of the chemical category of higher olefins. Studies conducted by the HOPA consortium on a large range of higher olefin category members (including Oct-1-ene) demonstrated sufficiently similar physico-chemical, environmental fate and toxicological properties to substantiate the basis for read-across. Therefore Oct-2-ene is expected to behave similarly. Justification for inclusion of Oct-2-ene within the boundaries of the higher olefins category, and the relevance of each category member as an analogue substance to Oct-2-ene, is provided in Section 13 (Document name: “HOPA Higher Olefins CJD with Category Matrix Report [rev 1 Sept 2016]”).

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

Species:

rabbit

Strain:

New Zealand White

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

4.7

Max. score:

110

Remarks on result:

other: Washed eyes

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

3

Max. score:

110

Remarks on result:

other: Unwashed eyes

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hour

Score:

0

Max. score:

110

Remarks on result:

other: Washed eyes

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hour

Score:

0.3

Max. score:

110

Remarks on result:

other: Unwashed eyes

Irritant / corrosive response data:

The maximum mean total irritation score at 1 hour post-exposure was 3.0 out of 110 for unwashed eyes and 4.7 out of 110 for washed eyes. Irritation was so minimal that washing the eye with water increased irritation scores at one hour. No irritation effects were seen 48 hours post-exposure; all effects were fully reversible.

Other effects:

None reported

Interpretation of results:

other: Not irritating according to EU CLP classification

Remarks:

Criteria used for interpretation of results: EU

Executive summary:

In a primary eye irritation study, 0.1 millilitre of 1 -octene, undiluted, was instilled into the conjunctival sac of the right eyes of six male and three female New Zealand White rabbits. Three males had their eyes washed 30 seconds post-exposure. Animals were then observed for 7 days. Irritation was scored by the method of Draize.

Mild irritation was noted 1 hour post-exposure in both washed and unwashed eyes. Irritation persisted to day 1 of the observation period, but was not noted on day 2 post-exposure. In this study, 1 -octene is not classified as an eye irritant based on EU classification.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or closely following OECD 405 guidelines and was GLP compliant.

Read-across to Oct-2-ene is claimed as valid basd on the justifications provided for both analogue and category approaches.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Thirty five guideline or near-guideline rabbit skin irritation studies have been conducted on 16 category members, ranging from hex-1-ene to alkenes, C20-24. In general, the studies show that these higher olefins are not skin irritants. There are a few studies that are exceptions, and this may be due to differences in laboratory methods i.e. use of occluded or semi-occluded conditions; duration of exposure (4 or 24 hours).

Twenty-two eye rabbit irritation studies have been conducted on 16 category members, ranging from hex-1-ene to alkenes, C20-24. It can be concluded from all of these studies that higher olefins are not irritating to the rabbit eye.

Based on a weight of evidence analysis of these findings, no classification for skin or eye irritation potential is necessary according to the CLP regulation.

In a primary dermal irritation study, 5 male and 1 female New Zealand White rabbits were dermally exposed to 0.5 millilitre of Gulftene 8 for 4 hours. Animals then were observed for 14 days and irritation was scored by the Draize method.

The test material application produced a primary irritation index of 3.42 calculated according to US EPA FIFRA guidelines, and mean scores of 1.9 for erythema/eschar formation and 1.1 for edema according to EU labelling restrictions. Compound-induced corrosion was not reported.

In a primary eye irritation study, 0.1 millilitre of 1 -octene, undiluted, was instilled into the conjunctival sac of the right eyes of six male and three female New Zealand White rabbits. Three males had their eyes washed 30 seconds post-exposure. Animals were then observed for 7 days. Irritation was scored by the method of Draize.

Mild irritation was noted 1 hour post-exposure in both washed and unwashed eyes. Irritation persisted to day 1 of the observation period, but was not noted on day 2 post-exposure. In this study, 1 -octene is not classified as an eye irritant based on EU classification.

Thirty five guideline or near-guideline rabbit skin irritation studies have been conducted on 16 HOPA category members, ranging from C6 C20-24. In general, the studies show that these higher olefins are not skin irritants. There are a few studies that are exceptions, and this may be due to differences in laboratory methods i.e. use of occluded or semi-occluded conditions; duration of exposure (4 or 24 hours). Based on a weight of evidence analysis of these findings, no classification for skin irritation potential is necessary according to the CLP regulation.

Twenty-two eye rabbit irritation studies have been conducted on 16 category members, ranging from C6 to C20-24. It can be concluded from all of these studies that higher olefins are not irritating to the rabbit eye. No classification for eye irritation potential is necessary according to the CLP regulation.

Read-across to Oct-2-ene is claimed as valid based on the justifications provided for both analogue and category approaches.