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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Section 1500.41
GLP compliance:
no
Remarks:
Study conducted pre-GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
EC Number:
227-561-6
EC Name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
Cas Number:
5888-33-5
Molecular formula:
C13H20O2
IUPAC Name:
(1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl prop-2-enoate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.