Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

In an in vivo study, undiluted Pentyl Cyclopentenone FAB was found to be moderatly irritating to the skin of rabbits. 
Moderate to severe eye irritation was seen in rabbits following instillation of the neat material and 50% in Tween 80. 
No respiritory irritation study is available.

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

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:
other: Stduy similar to guideline. Limited substance information (e.g. purity).
Qualifier:
no guideline available
Principles of method if other than guideline:
Modified Federal Hazardous Substances Labelling Act method.
Test substances are applied to one eye of each of three rabbits gently pulling the lower lid away from the eye ball and placing 0.1 mL in the sac so formed.
Modifications: Area of the cornea and iris affected was assessed as well as intensity.
Eyes are examined 24 hours after teatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes are examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.
GLP compliance:
no
Remarks:
The study pre-dates the indroduction of GLP in the UK
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
6 New Zealand White rabbits waighing between 1 and 2 kg and aged between 7-9 weeks, in good general health, are used for testing each material. Only one eye of each rabbit is used. All animals are inspected with a hand torch before any treatment and those with spontaneous eye lesions are rejected. Fluorescein is appled to the eye to assist in the detection of corneal lesions. Corneal thickness is also measured before the application of test materials (Burton, 1972. Fd. Cosmet Toxicol. 10 209).
Vehicle:
other: Tween 80
Controls:
other: untreated eye of each animal was used as a control
Amount / concentration applied:
0.1 mL of undiluted test material was applied
Observation period (in vivo):
Animals are carefully watched during an immediately after application of the test material for signs of discomfort or pain.
Fifteen minutes after application of test materail the eyes are inspected for conjunctival reactions. One day after application of the test material and then at daily intervals for 5 days per week for 3 weeks or undil the eye is considered to be of normal appearance, the eyes are inspected for corneal , conjunctival and iridial reactions.
Number of animals or in vitro replicates:
Three rabbits were used in this test. Two animals were pre-treated with corneal anaesthetic.
Details on study design:
Tools used to assess score: Eyes were examined with the aid of a hand torch for corneal, conjunctival and iridial reactions.
Other effects:
No other effects reported.

2-Pentyl cyclopent-2-enone caused moderate corneal opacities, affecting up to all the cornea, in all three rabbits. These opacities were associated with slight or moderate corneal swelling. All the animals has slight conjunctivitis, one animal had slight discharge, and iritis affecting up to all the iris. All three animals developed peripheral pannus, which was still present at the end of the test. (One animal was found dead on day 15, when it still had slight corneal opactiy). All three animals showed discomfort immediately after treatment.

Interpretation of results:
other: moderate to severe irritant
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of this test 2-pentyl cyclopentenone produced a generally moderate response, though peripheral pannus was produced in all three rabbits. It is very likey to cause pain if it enters the human eye.
Executive summary:

In an in vivo study, conducted prior to the introduction of GLP or the applicable OECD test guideline, undiluted 2 -Pentyl cyclopentan-2 -enone was applied to one eye of three New Zealand White rabbits.

Under the conditions of this test 2-pentyl cyclopentenone produced a generally moderate response, though peripheral pannus was produced in all three rabbits. It is very likey to cause pain if it enters the human eye.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study

Justification for selection of eye irritation endpoint:
Reliable in vivo study

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification