Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Magnusson, B, and Kligman, AM, (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm., 52, 268-276.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: P
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
No. of animals per dose:
10 males and 10 females were used in the exposure group
5 males and 5 females were used in the control group

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% w/v in corn oil
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: 25% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% w/v in corn oil
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: 25% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Skin Response After Challenge Procedure

Animal – Exposure Group

Immediate

24 hrs

48 hrs

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Male 6

-

-

-

Male 7

-

-

-

Male 8

-

-

-

Male 9

-

-

-

Male 10

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-

Female 6

-

-

-

Female 7

-

-

-

Female 8

-

-

-

Female 9

-

-

-

Female 10

-

-

-

Control Group

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance did not cause any skin response during the challenge procedure. The test substance is considered not sensitizing.
Executive summary:

This study examined the skin sensitization potential of Dilutene M5. Groups of 10 male and 10 female guinea pigs were induced with 0.1 % w/v of test substance in corn oil intradermally. 5 male and 5 female guinea pigs served as controls. The topical induction was performed with 50% w/v of test substance in corn oil. A topical challenge was then done with 25% w/v of test substance in corn oil. Animals were then scored for dermal reactions. No reaction was seen in any animal at any time during the experiment. The test substance is not sensitizing to skin.