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Description of key information

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:
from Nov. 27, 1996 to Feb. 12, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
other: Directive 92/69 EEC, B.6. "Acute Toxicity-Skin Sensitization", July 31, 1992.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Test material information:
Composition 1
Species:
guinea pig
Strain:
Himalayan
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
Age at delivery: 5 - 7 weeks
Body Weight at delivery: Pretest 384-400 g
Body Weight at beginning of Acclimatization period: Control and Test Group 323 - 415 g
Acclimatization: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visible signs of illness were used for the study.

Conditions
Standard Laboratory Conditions,
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ± 3 °C and for relative humidity between 40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.


Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
bi-distilled water
Concentration / amount:
Intradermal injections: three pairs of intradermal injections (0.1 ml/site)
Epidermal applications: 50 % in bi-distilled water
CHALLENGE: 25 % of test article
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
bi-distilled water
Concentration / amount:
Intradermal injections: three pairs of intradermal injections (0.1 ml/site)
Epidermal applications: 50 % in bi-distilled water
CHALLENGE: 25 % of test article
No. of animals per dose:
control: 5 males
test group: 10 males
Details on study design:
INDUCTION
Intradermal injections / performed on test day 1: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 6 cm area in the clipped region.

Epidermal applications / performed on test day 8: One week after the injections, the scapular area was clipped and shaved free of hair. A 2 x 4 cm patch of filter paper was saturated with the test article (50 % in bi-distilled water) and placed over the injection sites of the test animals. The volume of test article applied was approximately 0.3 g. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for 46 hours. The epidermal application procedure described ensured intensive contact of the test article. The guinea pigs of the control group were treated as described above with bi- distilled water only.

CHALLENGE / performed on test day 22: The test and control guinea pigs were challenged two weeks after the epidermal Induction application. The test and control guinea pigs were treated in the same way. Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea pig just prior to the application. Two patches (2x2 cm) of filter paper were saturated with the highest non-irritating concentration of 25 % (left flank) and the vehicle only (bi-distilled water applied to the right flank) using the same method as for the epidermal application. The volume of test article applied was approximately 0.2 ml. The dressings were left in place for 24 hours.
Approximately 21 hours after removal of the dressing the test sites treated with the test article were depilated with an approved depilatory cream. The cream was placed on the patch sites for 3-5 minutes and then washed off with a stream of warm running water. When the application sites were clean and any stains from the test article removed the animals were dried with a disposable paper towel and returned to their cages.
Challenge controls:
vehicle: bi-distilled water
Positive control substance(s):
yes
Remarks:
2-MERCAPTO- BENZOTHIAZOLE and ALPHA-HEXYLCINNAMALDEHYDE
Positive control results:
The positive control with 2-MERCAPTO- BENZOTHIAZOLE applied at concentration of 50 % in mineral oil is considered to be a sensitizer when used under the test conditions.
The positive control with ALPHA-HEXYLCINNAMALDEHYDE applied at concentration of 15 % in PEG 400 is considered to be a sensitizer when used under the test conditions.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Bi-distilled water only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Bi-distilled water only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Bi-distilled water only
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Bi-distilled water only
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Bi-distilled water only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.

SKIN EFFECTS AFTER INTRADERMAL INDUCTION - performed on test day 1

A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections.

SKIN EFFECTS AFTER EPIDERMAL INDUCTION - perfumed on test day 8

CONTROL GROUP

No erythematous or oedematous reaction was observed in the animals treated with bi-disti11ed water only.

TEST GROUP

As the test article stained the skin brownish/red, it was not possible to determine whether erythema was present or not. However no oedema was observed.

SKIN EFFECTS AFTER THE CHALLENGE - performed on test day22

CONTROL AND TEST GROUP

No positive reactions were observed in the animals neither when treated with bi- distilled water alone nor when treated with the test article at25 % in bi-distilled water.

A brownish/red discoloration was noted directly after removal of the patch. To remove discoloration all animals were depilated approximately 3 hours prior to challenge reading.

VIABILITYfMORTALITY / MACROSCOPIC FINDINGS

As there were no deaths during the course of the treatment period no necropsies were performed.

CLINICAL SIGNS, SYSTEMIC: No symptoms of systemic toxicity were observed in the animals.

BODY WEIGHTS

One animal (no. 588) of the test group lost weight during its acclimatization period. It recovered during the treatment period. One animal (no. 600) of the epidermal pretest lost weight during Its test article treatment period.

The body weight of the other animals was within the range of physiological variability known for this strain and age.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Therefore, the test article FAT45'176/A applied at a concentration of 25 % in bi-distilled water is considered to be a non-sensit1zer when used under the described test conditions.
Executive summary:

The Maximization-Test was performed with FAT45'176/A in accordance with OECD Guideline No. 406. In this study 0 % of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test article concentration of 25 % in bi-disti1led water. No skin reactions were observed in the control group.

Therefore, the test article FAT45'176/A applied at a concentration of 25 % in bi-distilled water is considered to be a non-sensit1zer when used under the described test conditions.


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

The Maximization-Test was performed with FAT45'176/A in accordance with OECD Guideline No. 406. In this study 0 % of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test article concentration of 25 % in bi-distilled water. No skin reactions were observed in the control group. Therefore, the test article FAT45'176/A applied at a concentration of 25 % in bi-distilled water is considered to be a non-sensitiser when used under the test conditions.



Migrated from Short description of key information:
The test article FAT45'176/A is considered to be a non-sensitizer when used under the test conditions.

Justification for selection of skin sensitisation endpoint:
OECD guidance test with GLP compliance

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance shall not be classified in accordance with CLP (Regulation EC No 1272/2008) for skin sensitisation. Data on respiratory sensitisation are lacking.