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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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:
other: Study similar to guideline. Limited information (e.g. purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test material and appropriate standards are applied to the clipped dorsum of rabbits for 4 hours under individual semi-occlusive patches. After removal of the patches, the treated areas are wiped and examined for evidence of irritation. Further assessments are made 24, 48 and 72 hours after treatments, and occasioanlly up to 7 days after treatment.
GLP compliance:
no
Remarks:
This study pre-dates the introduction of GLP in the UK

Test material

Constituent 1
Reference substance name:
2-pentylcyclopent-2-enone
IUPAC Name:
2-pentylcyclopent-2-enone
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
8 new Zealand White rabbits, aged 9-12 weeks are used for each test. The whole dorsal surface is clipped 3-4 days before the test is due to start, and animals in the telogen phase of hair growth are selected.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml of test solution is applied to a dry patch
Duration of treatment / exposure:
Up to 72 hours.
Observation period:
Up to 72 hours
Number of animals:
8 new Zealand White rabbits
Details on study design:
Scoring System:
Treatment sites weree assessed for erythema, oedema, cracking, scaling dryness, haemorage, ulceration, scabbing and exudation on a 8-point scale.
1 - marginal/very slight; 2 = slight; 3 = fairly distincy; 4 = quite distinct; 6 = becoming well developed; 8 = well developed; 10 = becoming severe; 12 = severe.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.75
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
4.5
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.25
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
2.75
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.25
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.25
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.25
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.75
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
4
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.25
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
2.75
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
5
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal: #8
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
2.5
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
2.5
Max. score:
12
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.19
Max. score:
12
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings
Score:
3.53
Max. score:
12
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Mean of 4, 24, 48 and 72 hour gradings per Site per Day
Score:
7.16
Max. score:
12
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: description of scoring system in study report
Conclusions:
An application (0.5 mL) of undiluted Pentyl Cyclopentenone FAB (2-Pentylcyclopent-2-enone) was found to be moderately irritating to the skin of rabbits.
Executive summary:

In an in vivo study, conducted prior to the introduction of GLP or the applicable OECD test guideline, undiluted Pentyl Cyclopentenone FAB (2-Pentylcyclopent-2-enone, 0.5 mL) was applied to the skin of 8 New Zealand White rabbits.

Mean erytherma and oedema scores of 3.19 and 3.53 (out of 12) were reported for the treated group, expressed as a mean of the 4, 24, 48 and 72 hour gradings. According to the scoring system in the report, this represented a moderate irritant. Other effects reported included cracking ( mean score 1.63/12) and scaling (0.125/12) of the skin. Reversiblity effects not fully assessed.