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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
Study period:
1982-03-18 - 1982-04-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline. Limited substance 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 predating adoption by OECD as part of TG406
Deviations:
no
GLP compliance:
not specified
Remarks:
The study pre-dates the introduction of GLP in the United Kingdom.
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Environmental Safety Division (Unilever in-house)
- Age at study initiation: no data.
- Weight at study initiation: about 320g.
- Housing: no data.
- Diet (e.g. ad libitum): no data.
- Water (e.g. ad libitum): no data.
- Acclimation period: no data.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data.
- Humidity (%): no data.
- Air changes (per hr): no data.
- Photoperiod (hrs dark / hrs light): no data.

IN-LIFE DATES: no data.
Route:
intradermal and epicutaneous
Vehicle:
other: For injection, vehicle was physiological saline containing 0.01% sodium dodecylbenzenesulphonate. Topical induction application was neat (no vehicle), and the challenge application was conducted in acetone/PEG.
Concentration / amount:
Induction injection, 2%; topical induction, 100% (neat); topical challenge, 25 or 15%.
Route:
epicutaneous, occlusive
Vehicle:
other: For injection, vehicle was physiological saline containing 0.01% sodium dodecylbenzenesulphonate. Topical induction application was neat (no vehicle), and the challenge application was conducted in acetone/PEG.
Concentration / amount:
Induction injection, 2%; topical induction, 100% (neat); topical challenge, 25 or 15%.
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: intradermal injection irritation tests were carried out to determine a suitable concentration for the induction of sensitisation. The selected concentration was 2%, in saline containing 0.01% sodium dodecylbenzenesulphonate (DoBS). Covered patch irritation tests were carried out to determine a suitable concentration for sensitisation induction and challenge. As 75% was considered insufficiently irritant, it was decided to use neat test substance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two.
- Exposure period: intradermal injection, followed one week later by 48-hour covered patch application.
- Test groups: one, ten animals (6 males, 4 females).
- Control group: 4 males treated with vehicle and 4 females untreated.
- Site: intradermal injections were made to a clipped and shaved area of skin in the dorsal shoulder. Topical patches were applied to a clipped and shaved area of skin on the trunk, behind the forelimbs.
- Frequency of applications: three pairs of intradermal injections; one topical application.
- Duration: topical application for 48-hours, one week after injections.
- Concentrations: intradermal injections (2 of each): 1) 50% Freund's complete adjuvant (FCA) in saline (with 0.01% sodium dodecylbenzenesulphonate); 2) 2% test substance in vehicle; 3) 2% test substance in 50:50 mixture of vehicle and FCA. Topical application: neat (no vehicle).

B. CHALLENGE EXPOSURE
- No. of exposures: three.
- Day(s) of challenge: 13/14 (after application of the induction patch), 21/22 and 28/29.
- Exposure period: 24 hours.
- Test groups: one, ten animals (6 males, 4 females).
- Control group: 4 males treated with vehicle (challenges 1 and 2 only) and 4 females untreated (all challenge exposures).
- Site: a clipped and shaved area of the trunk.
- Concentrations: 25% (challenge 1), 15% (challenge 2 and 3) in acetone/PEG400.
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches.
Challenge controls:
Treated controls: 4 males, treated the same way as animals administered the test substance, given a mock induction treatment in which the test substance was omitted.
Untreated controls: 4 females, previously untreated, are treated the same way as test animals at each challenge.
Positive control substance(s):
no
Positive control results:
No data.
Reading:
other: Challenge 1 (day 13/14)
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Reaction questionable
Remarks on result:
other: Reading: other: Challenge 1 (day 13/14). . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Reaction questionable.
Reading:
other: Challenge 1 (day 13/14)
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge 1 (day 13/14). . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge 2 (day 21/22)
Hours after challenge:
24
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge 2 (day 21/22). . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge 2 (day 21/22)
Hours after challenge:
48
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge 2 (day 21/22). . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge 3 (day 28/29)
Hours after challenge:
24
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge 3 (day 28/29). . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: Challenge 3 (day 28/29)
Hours after challenge:
48
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: Challenge 3 (day 28/29). . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.

No reactions seen in any control animals (treated or untreated).

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Jasmatone (2-n-hexyl cyclopentanone) was found to be not sensitising in a guinea pig maximisation 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, Jasmatone (2 -n-hexyl cyclopentanone) was found to be non sensitising. One, questionable, positive reaction was seen in 1/10 test animals 24 hours after the first challenge application, but no other positive reactions were reported in test animals or vehicle or untreated controls.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In an in vivo guinea pig maximisation test, Jasmatone (2 -n-hexyl cyclopentanone) was not found to be a skin sensitiser. One, questionable, positive reaction was seen in 1/10 test animals, 24 hours after the first challenge application, but no other positive reactions were reported in test animals or vehicle or untreated controls.

There was also no evidence of a sensitising effect in a second guinea pig maximisation test, nor in a maximisation test in 27 subjects.


Migrated from Short description of key information:
Jasmatone (2-n-hexyl cyclopentanone) was found to be not sensitising in two guinea pig maximisation tests (Unilever, 1982d; 1983) and in a human maximisation test (Epstein, 1980).

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
No respiratory sensitisation study available. However, such effects are unlikely as Jasmatone is not a skin sensitiser to guinea pigs and its low volatility indicates that significant inhalation is unlikely under anticipated conditions of use.

Justification for classification or non-classification

Based on negative results in three, reliable in vivo skin sensitisation studies, classification under the EU DSD or CLP regulations is not required.