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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Results are from an in vivo test conducted before the Reach regulation came into force requesting in vitro information.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30-06-1982 to 03-08-1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed using the Guinea Pig Maximization test (equivalent or similar to OECD 406), study was not performed under GLP conditions.
Justification for type of information:
Results are from an in vivo test conducted before the Reach regulation came into force requesting in vitro information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Results are from an non-LLNA because at the time of the test the GPMT test was the preferred test.

Test material

1
Chemical structure
Reference substance name:
Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
EC Number:
916-331-7
Molecular formula:
C14H20O2
IUPAC Name:
Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animals were bred in Environmental Safety Division
- Age at study initiation: no information available
- Weight at study initiation: 320 g (sensitization test)
- Housing: No information available
- Diet (e.g. ad libitum): RGP pellets, hay, cabbage ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No information available

ENVIRONMENTAL CONDITIONS
No information available.

IN-LIFE DATES: Not available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 0.01% dobs/saline (Injection induction), neat (topical induction) and acetone/PEG (application challenge)
Concentration / amount:
Injection induction: 0.8% Cyclabute in 0.01% dobs/saline
Application induction: 100% Cyclabute (tested as supplied)
Application challenge: 50% and 25% Cyclabute in acetone/PEG
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 0.01% dobs/saline (Injection induction), neat (topical induction) and acetone/PEG (application challenge)
Concentration / amount:
Injection induction: 0.8% Cyclabute in 0.01% dobs/saline
Application induction: 100% Cyclabute (tested as supplied)
Application challenge: 50% and 25% Cyclabute in acetone/PEG
No. of animals per dose:
Preliminary irritation test: 4 animals / application.
Main test:
- Cyclabute: 10 animals
- Treated controls: 4 animals / challenge
- Untreated controls: 4 animals / challenge
Details on study design:
RANGE FINDING TESTS:
Prior to the sensitization test, preliminary irritation tests were performed in order to select a suitable concentrations of test substance for the sensitization test; a preliminary intradermal injection test and a covered patch irritation test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injections and topical application)
- Exposure period: topical application followed one week after intradermal injection.
- Test groups: 10 test guinea pigs weighing about 320 g.
- Control group: treated and untreated.
- Site: Intradermal injections and topical applications were performed in the dorsal shoulder regions.
- Frequency of applications: both exposures were performed once per animal.
- Duration: The patch for topical application was held in place for 48 hours.
- Concentrations:
- Intradermal injections: a) two 0.1 mL injections of 50% FCA in 0.01% dobs/saline. b) two 0.1 mL injections of 0.8% gardocyclene in 0.01% dobs/saline. c) two 0.1 mL injections of test substance in solvent mixed 50/50 with FCA with a final concentration of 0.8% gardocyclene.
- For topical application the gardocyclene was tested as supplied.

B. CHALLENGE EXPOSURE
- No. of exposures: Two challenges; one on both flanks.
- Day(s) of challenge: 13 or 14 days after the application of the induction patch.
- Exposure period: The patch was held in place for 24 hours.
- Test groups: 10 test guinea pigs weighing about 320 g.
- Control group: treated and untreated.
- Site: shoulder regions (same sites as the induction exposures)
- Concentrations: first challenge: 50% gardocyclene in acetone/PEG. second challenge: 25% gardocyclene in aceton/PEG.
- Evaluation (hr after challenge): The treatment sites were examined for evidence of sensitization 24 and 48 hours after removal of the patches.

OTHER:
Identification of sensitization response:
Observation of skin reactions resulting from treated are scored according to the following system:
0 = no reaction
0.5 = very faint erythema (using non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema with or without oedema
n = necrosis
sp = small spots of erythema

A reaction in a test animal is considered to be a sensitization response if it is significantly greater than the response in any control animal. Where there is no response in controls, a test reaction of 1 or more is considered to be sensitizing.
Challenge controls:
Two types of controls were used:
- Treated controls: 8 guinea pigs of the same sex were selected, 4 each for the first and second challenge. Prior to the challenge, these animals received 4 intradermal injections of 50% Freund's complete adjuvant in the test solvent followed 7 days later by a 48 hour occluded patch of the test solvent over the injection sites.
- Untreated controls: at every challenge in the test, 4 previously untreated animals of the same sex and approximately weighing the same as the test animals at the challenge, were treated in exactly the same way as the test animals.
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% Cyclabute
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
No skin reactions seen
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% Cyclabute
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
No skin reactions seen
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% Cyclabute
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
4 animals showed very faint erythema and 1 animals showed very faint to faint erythema.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% Cyclabute. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 4 animals showed very faint erythema and 1 animals showed very faint to faint erythema..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% Cyclabute
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
5 animals showed very faint erythema.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% Cyclabute. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 5 animals showed very faint erythema..
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25% Cyclabute
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
2 animals showed very faint erythema.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25% Cyclabute. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2 animals showed very faint erythema..
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25% Cyclabute
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
1 animal showed very faint erythema.
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25% Cyclabute. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 animal showed very faint erythema..
Reading:
other: no information present
Hours after challenge:
24
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not applicable
Remarks on result:
other:
Remarks:
Information is not presented

Applicant's summary and conclusion

Interpretation of results:
other: Not skin sensitising
Remarks:
according to EU CLP (EC1272/2008 and its updates)
Conclusions:
Cyclabute was considered to be not sensitising in an OECD TG 406 test.
Executive summary:

This Guinea Pig Maximization Test (OECD 406) was performed to determine the sensitising potential of Cyclabute in guinea pigs. Prior to the sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test. For the main test, 10 guinea pigs were first induced by intradermal injections (with a concentration of 0.8% Gardocyclene (as named in the report. It is another name for Cyclabute) and topical application (with a concentration of 100% Gardocyclene). The selection of the final challenge concentrations were based on intradermal and topical effects seen at 1% and 100%. In view of this slight irritation at 100%, the the animals were subjected to 2 challenges with 50% and 25% solutions of Cyclabute in acetone/PEG, respectively. At 24 and 48 hours after the challenge the treatment sites were examined and scored for erythema, oedema, and necrosis. The grade of erythema and possible oedema and necrosis determine the possible sensitizing properties of the test substance. For Cyclabute only very faint erythema was observed. Based on this study, Cyclabute does not trigger a sensitization reaction in albino Dunkin/Hartley guinea pigs.