Decahydronaphthalene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-11-27 to 1989-12-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions: No positive control (not required by 1981 version of Test Guideline)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A skin sensitization test according to OECD 406 has already excisted since 1990 and is sufficient for evaluation of the skin sensitisation potential of the test substance.

Test material

Test material information

Constituent 1

Reference substance name:

Decahydronaphthalene

EC Number:

202-046-9

EC Name:

Decahydronaphthalene

Cas Number:

91-17-8

Molecular formula:

C10H18

IUPAC Name:

decahydronaphthalene

Details on test material:

decahydronaphthalene of Hüls AG, purity 99 %.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS: 
- Strain: Dunkin-Hartley (Bor: DHPW)
- Sex: female
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 375 g (mean test); 378 g (mean control)
- Housing: 1-5 animals in Makrolon-cages type IV
- Food (ad libitum): G4 Alleindiät für Meerschweinchen, Ssniff Speziealfutter GmbH, 4770 Soest
- Water (ad libitum): tap water
- Acclimation period: 5-8 days

ENVIRONMENTAL CONDITIONS:
- Temperature: 20 °C +/- 1 °C
- Humidity: 60 % +/- 5%
- Air changes: 15/ h
- Photoperiod: 12 h dark/ 12 h light

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: corn oil

Induction 2

Concentration / amount:

1st application: Induction 5 % intracutaneous
2nd application: Induction 60 % occlusive epicutaneous
3rd application: Challenge 20 % occlusive epicutaneous

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: corn oil

Challenge 2

Concentration / amount:

1st application: Induction 5 % intracutaneous
2nd application: Induction 60 % occlusive epicutaneous
3rd application: Challenge 20 % occlusive epicutaneous

No. of animals per dose:

20 test
10 control; treatment: vehicle

Details on study design:

1st application: Induction 5 % intracutaneous
2nd application: Induction 60 % occlusive epicutaneous
3rd application: Challenge 20 % occlusive epicutaneous
ADMINISTRATION/EXPOSURE 
- Induction schedule: injection followed 1 week later by patch treatment  for 48 hours
- Injection details: 
0.1 ml each at 6 positions on shoulders:   
2 x Freund's Complete Adjuvant / deionized water (50:50)   
2 x test substance 5 % in corn oil   
2 x test substance 5 % in Freund's Complete Adjuvant / corn oil (50:50)   
simultaneous and symmetrical application of each solution  
controls: corn oil instead of test substance
- Challenge schedule: 2 weeks after end of induction, patch treatment for  24 hours
- Concentrations used for challenge:   20 % in corn oil with filter paper on left side; corn oil on opposite  side   readings 24 and 48 hours after 
removal of patch
- Rechallenge: no
- Positive control: no
EXAMINATIONS
- Grading system:
  possible scores 0 / 1 / 2 / 3        
  0 % of animals scored > 0: no sensitization    
1 -  8 % of animals scored > 0: very slight sensitization    
9 - 28 % of animals scored > 0: slight sensitization   
29 - 64 % of animals scored > 0: distinct sensitization   
5 - 80 % of animals scored > 0: severe sensitization   
81 -100 % of animals scored > 0: extreme sensitization

Challenge controls:

Concentrations used for challenge:   
20 % in corn oil with filter paper on left side; 
corn oil on opposite  side   readings 24 and 48 hours after

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

RESULTS OF TEST
- Sensitization reaction: 
  0/20 animals positive at 24 hours and at 48 hours = no sensitization
  no animals positive in control group
  no skin reaction upon corn oil treatment on opposite side (both groups)
- Clinical signs: 
  1st induction, FCA + water application sites: erythema, edema, necroses
  1st induction, test substance + vehicle application sites: erythema and  edema in 20/20 animals, necroses in 3/20 animals
  1st induction, FCA + test substance + vehicle application sites:  erythema and edema in 20/20 animals, necroses in 13/20 animals
  1st induction, FCA + vehicle application sites: erythema, edema,  necroses in 7/10 animals
  1st induction, vehicle application sites: erythema in 4/10 control  animals
  2nd induction, test and control groups: erythema and edema in all FCA +  water injection sites with bleeding in some animals within 

1 hour; simlar  observations with lower incidence in FCA + test substance + vehicle  injection sites; crust formation within 24 hours.
- Other: Mean body weight gain 136 g in test group, 132 g in control  group = expected range.

Applicant's summary and conclusion

Conclusions:

In a dermal sensitisation study according to Magnusson and Kligman decahydronaphthalene showed no skin sensitisation in guinea pigs.

Executive summary:

In a dermal sensitisation study according to Magnusson and Kligman a group of twenty female guinea pigs received decahydronaphthalene as 5% dilution in corn oil by the intracutaneous route followed by dermal application of the 60% solution of the test item in corn oil in the induction phase.

Challenge was with 20% decahydronaphthalene in corn oil, no skin sensitisation was observed.