Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch number: sample no.1
- Purity: 90.5 %
- Before the treatment, the test substance was stored at -20°C and protected from light and was stored at +4 °C during the treatment

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: On day -1, they had a mean weight of 344 ± 18 g for the males and 333 ± 24 g for the females.
- Housing: individually
- Food and water: ad libidum
- Acclimation period: 5 days
- The animals were individually identified by tattooing the ear.

ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- Food and water: ad libidum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: paraffin oil.
Concentration / amount:
1st application: Induction 10 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin oil.
Concentration / amount:
1st application: Induction 10 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
No. of animals per dose:
10 male and 10 female
Details on study design:
1st application: Induction 10 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challenge controls:
yes (5 male and 5 female)
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: 1st and 2d reading
Hours after challenge:
24
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
other: 1st and 2d 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:

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions likely to have been caused by the sensitization potential of the test substance were observed in guinea-pigs.

Classification: not sensitizing
Executive summary:

The test substance was tested for skin sensitisation in a GPMT (OECD 406, GLP). Thirty guinea-pigs (15 males and 15 females) were allocated to 2 groups: a control group (5 males and 5 females) and a treated group (10 males and 10 females).

The sensitization potential of the test substance was evaluated after a 10-day induction period during which the animals were treated with the vehicle (control group) or the test substance (treated group). On day 1, in presence of Freund's adjuvant, 0.1 ml of the test substance was administered by intradermal route at a concentration of 10% in paraffin oil. On day 8, 0.5 ml of the test substance in its original form was applied by cutaneous route. After a period of 12 days without treatment, a challenge cutaneous application of 0.5 ml of the vehicle (left flank) and 0.5 ml of the test substance at the maximal non-irritant concentration of 25% in the vehicle (right flank) were prepared on a dry compress and this was then applied to all animals. The substances were held in place for 24 hours by means of an occlusive dressing. The cutaneous reactions were then evaluated at the challenge application site, 24 and 48 hours after removal of the dressing.

After the final scoring period, the animals were sacrificed and cutaneous samples were taken from the challenge application sites in all animals. Due to the absence of macroscopic cutaneous reactions, no histological examination was performed on the cutaneous samples.

A decrease in the spontaneous activity was noted in one animal of the treated group on days 4 and 5. No clinical signs were observed in the other animals of the control and treated groups.

No deaths occurred throughout the study.

The body weight gain of the treated animals was normal when compared to that of the control animals. No cutaneous reactions were observed 24 and 48 hours after the challenge application of the test substance.