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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes
Type of study:
split adjuvant test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: R7623 Technical, solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: aqueous methyl cellulose 1%
Concentration / amount:
- Induction: each animal received a dose of 50% test substance

- Challenge: each received the three test concentrations (5%, 10% and 50% w/w) and control dose in separate areas on the shaved back of the animal
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: aqueous methyl cellulose 1%
Concentration / amount:
- Induction: each animal received a dose of 50% test substance

- Challenge: each received the three test concentrations (5%, 10% and 50% w/w) and control dose in separate areas on the shaved back of the animal
No. of animals per dose:
20 animals, each treated with the same 3 test concentrations and control

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
all
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: all. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
all
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: all. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
Executive summary:

The test substance suspended in aqueous methy cellulose 1% at several concentrations (50%, 10% and 5%) and administered epicutaneously to guinea pigs in the challenge phase, resulted in no skin reaction in any of the experimental nor control animals. No signs of systemic toxicity were observed in any of the animals during the study period.

The test results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.