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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Initiation: July 13, 1983 - Termination: September 15,1983.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study, no information on test item purity, no positive control

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
12 May 1981
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study performed before LLNA method was established

Test material

1
Chemical structure
Reference substance name:
Octahydro-4,7-methano-1H-indene-5-methanol
EC Number:
260-789-4
EC Name:
Octahydro-4,7-methano-1H-indene-5-methanol
Cas Number:
57526-50-8
Molecular formula:
C11H18O
IUPAC Name:
{tricyclo[5.2.1.0²,⁶]decan-8-yl}methanol
Test material form:
liquid
Details on test material:
Chargen Nr. RM 13 2414
no information on purity
Specific details on test material used for the study:
No information on purity. However, as it is stated in the section 13, the substance and its composition have remained essentially the same over the last decades.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Weight at study initiation: mean 233.4 g (range: 189-261)
- Housing: in groups of 5 per cage in fully air-conditioned rooms
- Diet: mixed feed for breeding rabbits and guinea pigs ERKA 8300 (R. Koch OHG, Hamm), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 12 hours per day

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
a) 50 % FCA in isotonic saline; b) test substance (5 %) in vehicle; c) test substance (5 %) in FCA
Day(s)/duration:
1 d
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
pure substance
Day(s)/duration:
2 d
Adequacy of induction:
highest technically applicable concentration used
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
pure test substance
Day(s)/duration:
1 d
Adequacy of challenge:
other: highest technically applicable concentration used
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
50% in vehicle
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 animals in control group, 20 in test group
Details on study design:
1st application: Induction 5 % intracutaneous (day 1)
2nd application: Induction 100 % occlusive epicutaneous (day 9)
3rd application: Challenge, pure substance occlusive epicutaneous (day 22)
4th application: Challenge 50 % occlusive epicutaneous (day 35, after effects of first challenge totally subsided)
Challenge controls:
2
Positive control substance(s):
not specified

Results and discussion

Positive control results:
not specified

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
50% in petrolatum
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
marginal to well defined erythema
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in petrolatum
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
marginal erythema, hardened skin
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
50% in petrolatum
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
marginal erythema
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
50% in petrolatum
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
marginal (5) to well defined (1) erythema
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

first challenge / undiluted test substance:

first reading (24 h after patch removal: 9/10 (90%) control animals with erythema and 14/20 (70%) of test animals with erythema

second reading (48 h after patch removal: 5/10 (50%) control animals with erythema and 12/20 (60%) of test animals with erythema; no oedema in control animals, 1/20 test animals with oedema

second challenge/ undiluted test substance:

first reading (24 h after patch removal: 10/10 (100%) control animals with erythema and 14/20 (70%) of test animals with erythema; 5/10 (50%) controls animals with oedema and 1/20 (5%) test animals with oedema

second reading (48 h after patch removal: 8/10 (80%) control animals with erythema and 15/20 (75%) of test animals with erythema;

4/10 (40%) controls animals with oedema and 3/19 (16%) test animals with oedema

second challenge / 50% test substance in petrolatum:
Skin reaction 24 hours after patch removal:
No difference was noted between control and treated animals.

Skin reaction 48 hours after patch removal:
Marginal skin reactions were noted in treated animals: 5% increase in  weak erythema and 5% increase in well-defined erythema compared to the  control group.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this test the test substance did not show sensitising properties.
Executive summary:

The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406 and GLP. Intradermal induction was performed with 5% test substance in parraffin and dermal induction with undiluted test item. First challenge was performed with undiluted test substance. However, due to irritating effects already observable in the control group no evaluation with respect to sensitising effects was possible. The second challenge was performed with undiluted test substance (left flank) and 50% test substance in petrolatum (right flank). Again, no evaluation of the left flanks was possible due to irritating effects already observable in the control group. Treatment with 50% test substance in petrolatum did not cause skin sensitisation.