Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate

Endpoint summary

Description of key information

not skin irritating in vivo

not eye irritating in vivo

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:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Study conducted pre-GLP.

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Section 1500.41

GLP compliance:

no

Remarks:

Study conducted pre-GLP.

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hour(s)

Observation period:

24 and 72-h post dosing

Number of animals:

6

Details on study design:

Six mal New Zealand albino rabbits in a weight range of between 2.0 and 2.5 kilograms were used in this experiment. The animals were housed individually and maintained with standard laboratory procedure. Water was available at all times with the exception of the 24 hour exposure period. The trunks were clipped free of hair and one inch square abrasions were made through the stratum corneum with care being taken not to abrade sufficiently deep to cause bleeding and disturb the derma. The abraded areas were rotated throughout the six rabbits. A 0.5 ml portion of the test material was introduced under a one square inch gauze patch to the abraded and non-abraded skin. Patches were held in place with Dermicel tape. The trunks of the animals were wrapped with rubberized cloth during the 24 hour exposure period and the animals were kept immobilized in an animal holder.

The animals were observed closely during the first eight hours for discomfort and other adverse physical signs. 24 and 72 hours after exposure the treated areas were observed and evaluated for erythema and eschar formation as well as for edema in a range of 0 – 4 as described in the U.S. Code of Federal Regulations, Section 1500.

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: non-abraded skin

Remarks:

intact and abraded skin, no scoring at 48 h

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: non-abraded skin

Remarks:

intact and abraded skin, no scoring at 48 h

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: abraded skin

Remarks:

intact and abraded skin, no scoring at 48 h

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: abraded skin

Remarks:

intact and abraded skin, no scoring at 48 h

Irritant / corrosive response data:

No irritation or other clinical signs of deviation from the normal were observed at either 24 or 72 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

Isobornyl acrylate when applied in the quantity of 0.5 ml, to abraded and non-abraded skin sites of New Zealand albino rabbits did not produce any clinical signs of erythema, eschar or edema formation.

Executive summary:

The cutaneous irritation that could be induced by ISOBORNYL ACRYLATE was evaluated in the rabbit according to the U.S. Code of Federal Regulations, Section 1500.41The substance was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours. No irritation or other clinical signs of deviation from the normal were observed at either 24 or 72 hours. Under these experimental conditions, ISOBORNYL ACRYLATE was considered as a non-irritant when applied 24 hours to the rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

Study conducted pre-GLP.

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, section 1500.42

GLP compliance:

no

Remarks:

Study conducted pre-GLP.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
The animals were housed and fed individually and maintained in accordance with standard laboratory procedure. Water was available at all times.

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each treated animal

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

72 hours, unrinsed

Observation period (in vivo):

7 days after treatment

Number of animals or in vitro replicates:

6

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.61

Max. score:

4

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: re-evaluated according to GHS criteria

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: re-evaluated according to GHS criteria

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.61

Max. score:

4

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: re-evaluated according to GHS criteria

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 7d

Remarks on result:

other: re-evaluated according to GHS criteria

 

Classification of eye irritation studies according GHS-criteria

 

Substance:Isobornyl acrylate                                       IBA                           CAS:5888-33-5

 

Internal No.:LITSU 95-0072

 

Date/Expert:06-12-18/Am

 

Animal No.	Corneal opacity/Hornhauttrübung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	1	1	1	1	0	n.d.
2	1	1	0	0,66	0	n.d.
3	0	0	0	0	0	n.d.
4	1	1	1	1	0	n.d.
5	1	1	0	0,66	0	n.d.
6	1	0	0	0,33	0	n.d.
							none
Animal No.	Iritis/Regenbogenhautentzündung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	0	n.d.
2	0	0	0	0	0	n.d.
3	0	0	0	0	0	n.d.
4	0	0	0	0	0	n.d.
5	0	0	0	0	0	n.d.
6	0	0	0	0	0	n.d.
							none
Animal No.	Conjunctiva redness (erythem) /Bindehautrötung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	1	1	1	1	0	n.d.
2	1	1	0	0,66	0	n.d.
3	0	0	0	0	0	n.d.
4	1	1	1	1	0	n.d.
5	1	1	0	0,66	0	n.d.
6	1	0	0	0,33	0	n.d.
							none

 

Animal No.	Conjunctiva chemosis /Bindehautödem[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	0	n.d.
2	1	0	0	0,33	0	n.d.
3	0	0	0	0	0	n.d.
4	1	1	0	0,66	0	n.d.
5	1	0	0	0,33	0	n.d.
6	0	0	0	0	0	n.d.
							none

 

 

Classification: Hazard Category

none

n.d. = no data

 

Classification Criteria for serious Eye Damage/Eye Irritation

 

Category 1

 

• Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
• Mean Draize score in 2 of 3 animals:

     corneal opacity≥ 3

     iritis ≥ 1,5

 

 

Category 2

 

• Reversible adverse effects on cornea, iris, conjunctiva
• Mean Draize score in 2 of 3 animals:

corneal opacity≥1

iritis≥1

redness≥2

chemosis≥2

 

 

Subcategory 2A

 

• Reversible in 21 days

 

Subcategory 2B

 

• Reversible in 7 days

 

 

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: not irritating

Executive summary:

In a primary eye irritation study ( according to Code of Federal Regulations, section 1500.42) 0.1 mL undiluted ISOBORNYL ACRYLATE was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.

In this study, Isobornyl acrylate is not irritating to eyes.

OECD GHS Category: none

EU GHS Category: none

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

Isobornyl acrylate when applied in the quantity of 0.5 ml, to abraded and non-abraded skin sites of albino rabbits did not produce any clinical signs of erythema, eschar or edema formation in a standard skin irritation study.

Eye irritation

In a primary eye irritation study with standard protocol (Draize scoring), the substance showed slight effects of irritation which were fully reversible within 7 days.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

According to the criteria as of directive 1272/2008/EC or UN-GHS, no classification is warranted by the intrinsic properties based on available data.

However, due to the existing harmonised Annex VI classification as irritant to skin, eye and respiratory tract, the substance has to be classified (group classification “monoalkyl or monoaryl or monoalkyaryl esters of methacrylic acid with the exception of those specified elsewhere in this Annex” (Index 607-133-00-9)).