5-vinylnorborn-2-ene

Endpoint summary

Description of key information

Available animal data indicate that VNB is an moderately irritating to rabbit skin, and is very slightly irritating to the rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted 0.5 ml

Duration of treatment / exposure:

4 hour(s)

Observation period:

Sites of application were inspected for signs of inflammation and injury at 1 hr and 1,2,3,7,and 10 days.

Number of animals:

3 males, 3 females

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk
- Type of wrap if used: gauze loosely covered with polythene sheeting.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, but excess material removed with water moistened gauze.
- Time after start of exposure: 4 hr

SCORING SYSTEM: Erythema and edema were scored and recorded on a 5 point scale (0= no reaction, 4= severe reaction).

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hour observations

Score:

1.46

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hour observations

Score:

0.43

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

There was marked erythema and edema at 1-2 days and thereafter slowly resolving, completely resolved by 10 days. Desquamation was observed in all animals from day 7. Necrosis was not seen.

Inspection time after removed of wrap	Erythema score. Average (range)	Edema score. Average (range)
1 hour	0.7 (0 -1)	1.2 (1 -2)
1 day	2.0 (1 -3)	0.7 (0 -1)
2 days	1.2 (0 -2)	0.3 (0 -1)
3 days	1.2 (0 -2)	0.3 (0 -1)
7 days	0.2 (0 -1)	0.3 (0 -1)
10 days	0	0

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

VNB is a mild to moderate irritant to rabbit skin.

Executive summary:

Ballantyne et al (1997) published results showing that the substance ethylidene norbornene is a mild to moderate irritant to rabbit skin (4 -hr occlusive exposure). All symptoms reversed within 10 days.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Comparable to guideline study. Well documented study which meets basic scientific principles.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Method not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A volume of 0.1 ml undiluted substance was applied to the conjunctival sac of one eye of each rabbit. 

Observation period (in vivo):

Eyes were examined for signs of ocular and periocular inflammation and injury at 1, 4, and 24hr and 2,3,7 days postinstillation.

Number of animals or in vitro replicates:

3 males, 3 females

Details on study design:

SCORING SYSTEM: Iritis and conjunctival irritation were scored according to Draize.

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hour observations

Score:

0.53

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Max score seen 1

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 48, 72 hour observations

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hour observations

Score:

0.07

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Corneal effects were not observed and therefore not reported in the results above.  Ther was slight  conjunctival hyperemia, which began to resolve after 24 hr, was minimal  by 2 days and all eyes normal by 7 days. A marked chemosis was at a maximum  at 1-4 hr but quickly resolved. Mild transient iritis was seen but resolved within 24hrs.

Mean and range of scores for eye irritation produced by ENB instilled in the rabbit eye. Range shown in brackets.

Observation time	Redness	Chemosis	Iritis
1 hr	1.0 (all 1)	1.2 (1 -3)	0.3 (0 -1)
4 hr	1.0 (all 1)	1.0 (1 -2)	0.2 (0 -1)
24 hr	1.0 (all 1)	0.2 (0 -1)	0
2 days	0.3 (0 -1)	0	0
3 days	0.1 (0 -1)	0	0
7 days	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: EU

Conclusions:

ENB is a slight transient irritant to the rabbit eye.

Executive summary:

Ballantyne et al (1997) published results showing that vinyl norbornene is slightly irritating to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Occluded contact with 0.5 ml of undiluted the substance vinyl norbornene for 4 hrs produced mild to moderate erythema and edema on rabbit skin, which resolved by 7 -10 days; necrosis was not seen. 0.1 ml of undiluted VNB instilled into the rabbit inferior conjunctival sac caused conjunctival hyperemia that significantly resolved by 48 h post-instillation and disappeared completely within 7 days.

 

Justification for selection of skin irritation / corrosion endpoint:
Only study in dossier

Justification for selection of eye irritation endpoint:
Only study in dossier

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

SKIN: From the available data, the level of skin irritation as measured by erythema, the most severe effect is not sufficient to warrant classification as a skin irritant under directive 67/548. Individual animal data is not available to enable a definitive classification against the criteria in regulation 1272/2008. However, it is not conceivable that that the level of edema seen would be sufficient (max level 1) to warrant classification and unlikely that the erythema findings would be sufficient either (max level 2 on days 2 and 3 and range 2 -3 on day 1) so a classification of irritant under the CLP regulation does not seem warranted either. However, as a hydrocarbon, use of the risk phrases R66/EUH066 would seem appropriate.

EYE: Available evidence from a study using vinyl norbornene indicates that the level of eye irritation produced by VNB is not likely to be sufficient to warrant classification.