N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide

Endpoint summary

Description of key information

An OECD 404 study was performed in rabbits in order to determine the irritation properties of MGK 264 when applied undiluted to the skin. The mean values for erythema were less than 2 and the mean values for oedema were less than 1. All findings were reversible within a 7 day scoring interval. Based on the results of this study MGK 264 may be classified as non-irritating to the skin.

An OECD 405 study was performed in rabbits in order to determine the irritation properties of MGK 264 when applied undiluted to the eye. The mean values for corneal opacity and iritis were 0, the mean values for conjunctival redness were less than or equal to 1 and the mean values for conjunctival oedema were less than 1. Based on these results MGK 264 may be classified as non-irritating to the 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

Study period:

17 Nov 2004 to 10 Mar 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

not specified

GLP compliance:

yes

Specific details on test material used for the study:

MGK 264
Lot No.: AA7093
Purity: 95.2% MGK 264 (From CofA)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals.

The animal room temperature and relative humidity ranges were 70-72°F (21-22°C) and 34-55%, respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12h ligh/12h dark cycle and room ventilation was set to produce 10-15 air changes/hour. The animal room temperature and relative humidity were recorded a minimum of once daily.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

On day -1, the animals chosen for use on the primary skin irritation study had the fur removed from the dorsal area of the trunk using an animal clipper. Care was taken to avoid abrading the skin during the clipping procedure.

Vehicle:

unchanged (no vehicle)

Remarks:

The test material was administered as received from the Sponsor.

Amount / concentration applied:

0.5mL at 100% concentration (as received), over approximately 1 inch x 1 inch

Duration of treatment / exposure:

After a four-hour exposure period, the binding materials were removed from each animal and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with deionized water, followed by dry gauze.

Observation period:

Animals were examined for signs of erythema and edema and the responses scored at I hour after patch removal and 24, 48, 72 hours, and 7 days after patch application according to the Macroscopic Dermal Grading System.

Number of animals:

3, Male

Details on study design:

Preperation
Fur shorn with animal clippers

Application
0.5mL at 100% concentration (as received), over approximately 1 inch x 1 inch.

Exposure
The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. After a four-hour exposure period, the binding materials were removed from each animal and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with deionized water, followed by dry gauze. Acetone was used to remove sticky tape residue outside of the test area.

Observation
Animals were examined for signs of erythema and edema and the responses scored at I hour after patch removal and 24, 48, 72 hours, and 7 days after patch application according to the Macroscopic Dermal Grading System

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7 day scoring interval

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7 day scoring interval

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7 days scoring interval

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no irritation

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 7 day scoring window

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 7 day scoring window

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Exposure to the test article produced well-defined erythema on 3/3 test sites at the 1h scoring interval and very slight edema on 2/3 test site at the 24h scoring interval. The dermal irritation resolved completely on all test sites by the study day 7 scoring interval.

Other effects:

Additional dermal findings included desquamation, which was noted on 3/3 test sites.

Summary:

Mean Irritation Scores in Individual Animals
Animal No./Sex	Erythema	Edema
R27571M	1.67	0.00
R2763/M	1.67	0.33
R27651M	1.67	0.33
Irritation Rating	Nonirritant	Nonirritant

Conclusions:

Based on the EEC Evaluation Criteria, MGK® 264 is classified as a non-irritant to the skin of the rabbit for erythema and edema as is indicated in the result summary table.

Executive summary:

Summary:

Mean Irritation Scores in Individual Animals
Animal No./Sex	Erythema	Edema
R27571M	1.67	0.00
R2763/M	1.67	0.33
R27651M	1.67	0.33
Irritation Rating	Nonirritant	Nonirritant

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

MGK 264 may be classified as non-irritating to the skin or eye based on OECD 404 and OECD 405 compliant experimental studies.