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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
This test was already available (it was performed for cosmetic regulation compliance), before REACH regulation requirements.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Young adult female guinea pigs of the Dunkin-Hartley strain were obtained from Charles River. Animais were ordered nulliparous and non-pregnant, whithin the weight range of 300 to 350 grams and 4 to 5 weeks of age.
After arrivai, animais were identified by temporary markings. An acclimatisation period of at least 5 days allowed the assessment of the health status of the animals.
Animais were housed in groups of 5, in stainless steel cages. Controls for the animal room were set to maintain temperature within the range of 20-24°C and relative humidity within the range of 45-65%.
Both diet and water were allocated ad libitum. The food was an antibiotic-free pelleted diet, Altromin MSK, obtained from A. Rieper.
Food and water were checked on a regular basis to control the presence of contaminant substances.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
6 hours, repeated at weekly intervals (days 8 to 9, 15 to 16 of the study)
Adequacy of induction:
highest technically applicable concentration used
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: acetone
Concentration / amount:
100%, 0.2ml
Day(s)/duration:
6 hours
Adequacy of challenge:
not specified
No. of animals per dose:
20 guinea pigs
Details on study design:
Animals were allocated to treatment to give a test group of 20 animals and a control group of 10 animals.
On the day of treatment (day 1), the hair was clipped from the left flank of each animal. Animals of the test group were treated with the undiluted test product. A gauze patch measuring 20 x 20 mm was covered with 0.4 ml of the test substance and placed onto the selected skin area. This was secured in position by encircling the trunk of animal with a length of adhesive strapping. The animals of the control group were similarly treated with the selected vehicle i.e. corn oil.
After a 6-hour exposure period, the dressings were removed and the treated areas were cleaned of remaining test substance or vehicle by washing with warm water.
After approximately 24 hours after removal, the treated sites were examined for signs of reaction to treatment. The signs were scored using the scale previously described (see paragraph 3.3.2).
These procedures were repeated at weekly intervals (days 8 to 9 and 15 to 16 of the study).

On day 29, the hair was removed with electric clippers from both the anterior and posterior regions of the right flank of all animals:
A 0.2 ml aliquot of the undiluted test substance was spread evenly over an absorbent patch measuring approximately 20 x 20 mm. This was placed onto the skin of the posterior region of the prepared site on the right flank. All animals of both the treated and the control groups were treated with both the test product and the vehicle. After a 6-hour exposure period, the dressings were removed and the treated areas were cleaned of remaining test substance or vehicle by washing with warm water.
After approximately 21 hours after removal of the patches, the treated sites were again clipped free of hair. Three hours later (i.e. 24 hours after removal of the patches), treated sites were examined for signs of reaction to treatment. The signs were scored using the scale previously described (

Challenge controls:
A 0.2 ml aliquot of the vehicle selected for the challenge i.e. acetone was spread evenly over an absorbent patch measuring approximately 20 x 20 mm and was placed onto the anterior region of the prepared site. All animals of both the treated and the control groups were treated with both the test product and the vehicle.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not tested

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Body weight changes during the period of the study were generally similar in animals from both test and control groups
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Body weight changes during the period of the study were generally similar in animals from both test and control groups
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% of vehicle selected for challenge i.e. acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Body weight changes during the period of the study were generally similar in animals from both test and control groups
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100% of vehicle selected for challenge i.e. acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Body weight changes during the period of the study were generally similar in animals from both test and control groups
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% of vehicle selected for challenge i.e. acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Body weight changes during the period of the study were generally similar in animals from both test and control groups
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% of vehicle selected for challenge i.e. acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Body weight changes during the period of the study were generally similar in animals from both test and control groups
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The skin sensitization test was performed according to OECD 406 guideline. The data indicate that, in the guinea pig, the test product does not elicit a sensitisation response.