Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chlorocyclododecanone
EC Number:
679-917-9
Cas Number:
35951-28-1
Molecular formula:
C12H21ClO
IUPAC Name:
2-chlorocyclododecanone
Test material form:
other: solid
Details on test material:
Name of test material (as cited in study report): Chlorocyclododecanone

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: GOHI; SPF-quality guinea pigs (Himalayan spotted)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Environmental Safety Division
- Weight at study initiation: approximately 312g - 328g
- Water (e.g. ad libitum): ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
5%
No. of animals per dose:
15 female / 3 female animals (nulliparous and non-pregnant)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
dicrete/patchy erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: dicrete/patchy erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
discrete/patchy erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: discrete/patchy erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: None.

Any other information on results incl. tables

No toxic symptoms were evident in the guinea pigs of the control or test group.

Seven (at the 24-hour reading) and nine (at the 48-hour reading) out of 10 test animals showed discrete/patchy erythema after the challenge treatment with Chlorocyclododecanone at 5% in PEG 400. No skin effect was observed in the control group.

One animal (no. 796) of the control group was found dead on test day 11. At necropsy, no findings were noted.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study findings in an adjuvant sensitisation test in guinea pigs, Chlorocyclododecanone is considered to be a skin sensitiser.
Executive summary:

In order to assess the cutaneous allergenic potential of Chlorocyclododecanone, the Maximization-Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD No.406 and the Directive 96/54/EEC, B.6.

The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test article in PEG 400 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test article at 25% in PEG 400 one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 400 and FCA / physiological saline and epidermally induced with PEG 400 under occlusion.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test article at 5% in PEG 400 and PEG 400 alone under occlusive dressing.

Cutaneous reaction were evaluated at 24 and 48 hours after removal of the dressing.

Seven (at the 24 -hour reading) and nine (at the 48 -hour reading) out of the 10 test animals showed discrete/patchy erythema after the challenge treatment with Chlorocyclododecanone at 5% in PEG 400. No skin effect was observed in the control group.

Based on the above mentioned findings in guinea pigs, Chlorocyclododecanone is considered to be a skin sensitizer.

Categories Display