Registration Dossier

Administrative data

Description of key information

In a dermal sensitisation study according to Magnusson and Kligman (Hüls AG, 1989) a group of twenty female guinea pigs received tetrahydronaphthalene as 20% dilution in corn oil by the intracutaneous route followed by dermal application of the undiluted test item in the induction phase.

Challenge was with undiluted tetrahydronaphthalene. In summary no skin sensitisation was observed.

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:
1989-02-21 to 1989-03-17
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)
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 1989 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
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
- Weight at study initiation:    test group mean 293 g; control group mean 301 g
- Number of animals: 20
- Controls: 10 animals; treatment: vehicle
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
1st application: Induction 20 % intracutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % occlusive epicutaneous
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
1st application: Induction 20 % intracutaneous
2nd application: Induction 100 % occlusive epicutaneous
3rd application: Challenge 100 % occlusive epicutaneous
No. of animals per dose:
20 test
10 control
Details on study design:
ADMINISTRATION/EXPOSURE 
- Induction schedule: single intracutaneous treatment, 1 week later  dermal induction; slight to medium inflammation caused (10 % SDS in  vaseline)  before application of patch; patch removed after 48 h
- Challenge schedule: after 2 further weeks, occlusive epicutaneous,  removal of patch after 24 h, readings after further 24 and 48 hours.
EXAMINATIONS
- Grading system:        
0  %  of animals positive: no sensitisation  
1 -   8 % of animals positive: very slight sensitisation  
9 -  28 % of animals positive: slight sensitisation
29 - 64 % of animals positive: distinct sensitisation
65 - 80 % of animals positive: severe sensitisation
81 -100 % of animals positive: extreme sensitisation
Positive control substance(s):
not required
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
see below
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see below.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
see below
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: see below.

RESULTS OF TEST
- Sensitization reaction: 0/20 (none of the animals showed a positive reaction at 24 and 48 hrs)
- Irritation: No reaction was caused by the corn oil patch.
- Body weights: No treatment-related effects were observed.
- Clinical signs: After intracutaneous application, the places of  injections showed intense erythema and edema as well as necroses in case of treatment 

with Freund's Complete Adjuvant (FCA), distinct erythema and edema in case 

of treatment with 20 % test substance, and slight erythema  in case of 

treatment with corn oil. 
- After removal of the first patch (i.e. 2nd induction treatment), all animals  treated with FCA displayed at the locations of injection moderate  to severe  inflammation, part of them bleeding and showing crusts 24 hours  after patch 

removal.

Conclusions:
In a dermal sensitisation study according to Magnusson and Kligman tetrahydronaphthalene 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 tetrahydronaphthalene as 20% dilution in corn oil by the intracutaneous route followed by dermal application of the undiluted test item in the induction phase.

Challenge was with undiluted tetrahydronaphthalene, no skin sensitisation was observed.

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

Partly cited from SIAR to SIAM 19 (Berlin, 19-22 October 2004):

In a guinea pig maximization test according to OECD TG 406 (1981), none of the 20 test animals showed a positive reaction 24 as well as 48 hours after challenge with the pure substance. Positive controls were not used in this study (Hüls AG, 1989).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

1,2,3,4-Tetrahydronaphthalene was not sensitizing in a guinea pig maximization test, in which no positive controls were used (OECD TG 406, 1981).