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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(According to the Method of Magnusson and Kligman, but pre-dating adoption by OECD as part of TG406)
Deviations:
no
GLP compliance:
no
Remarks:
(The study pre-dates the introduction of GLP in the UK)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Albino Dunkin/Hartley guinea pigs are bred in Environmental Safety Division are used. They are selected for the preliminary irritation tests and for the sensitisation test according to weight and sex.
Route:
intradermal
Vehicle:
other: i) injection induction solution: 0.01% Dobs/saline; ii) application induction solution: ethanol; iii) application challenge solution: ethanol
Concentration / amount:
i) induction (intradermal injection): 0.2%
ii) induction (covered patch application): 25%
ii) challenge (covered patch application): 5%
Route:
epicutaneous, occlusive
Vehicle:
other: i) injection induction solution: 0.01% Dobs/saline; ii) application induction solution: ethanol; iii) application challenge solution: ethanol
Concentration / amount:
i) induction (intradermal injection): 0.2%
ii) induction (covered patch application): 25%
ii) challenge (covered patch application): 5%
No. of animals per dose:
Ten test guienea pigs weighing about 320 g are selected. There are either 6 males and 4 females or vice versa.
Challenge controls:
Two types of controls are used:
Treated controls: 4 guinea pigs of the same sex are given mock induction treatment at the time tme and in the same way as for the test animals except that the test substance is omitted from the injection and application preparation.
Untreated controls: At every challenge in the test 4 previously untreated animals of the same sex and weighing approximately the same as the test animals at that challenge are treated in exactly the same was as the test animals.
Positive control substance(s):
no
Positive control results:
no data
Reading:
other: challenge 1
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
other: challenge 1
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
other: challenge 2
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 2
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 2. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
other: challenge 3
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 3. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
other: challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 3. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
other: challenge 4
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 4. . Hours after challenge: 24.0. Group: test group. Dose level: 5% . No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
other: challenge 4
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 4. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Interpretation of results:
sensitising
Remarks:
Migrated information weak to moderate sensitiser Criteria used for interpretation of results: expert judgment
Conclusions:
2-Pentylcyclopentenone was found to be a weak/moderate sensitiser in a guinea pigmaximisation test, according to the method of Magnusson and Kligman.
Executive summary:

In an in vivo guinea pig maximisation test, according to the method of Magnusson and Kligman but conducted prior to the introduction of GLP or the applicable OECD test guideline. 2 -Pentylcyclopentanone was found to be a weak/moderate sensitiser, 6/10 guinea pigs sensitised after one challenge.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Migrated from Short description of key information:
Pentyl cyclopentenone was found to be a weak/moderate sensitiser in two guinea pig maximisation test.

Justification for selection of skin sensitisation endpoint:
Reliable in vivo study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on positive results in two in vivo skin sensitisation studies, classification under the EU DSD or CLP is required.