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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
Study period:
30/9/1996 to 21/1/1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
the control group was treated with ethanol to detect a possible irritating effect. During first induction appl. 0,1mL of different test article conc. were applied to skin area of 2cm2 instead of 8cm2. No incidence noted
GLP compliance:
yes
Type of study:
open epicutaneous test
Justification for non-LLNA method:
A skin sensitisation study carried out on guinea pigs in 1997 and according to TG OECD 406 is available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
other: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. (Switzerland)
- Age at study initiation: 5-7 weeks at acclimatization start
- Weight at study initiation: 344-432 g at acclimatization start
- Housing: Individually in wire mesh type-3 cages. Air conditioned with 10-15 air changes/h, RT=22ºC, relative humidity 40-70%, 12h artificial light/12h dark, music during light period
- Diet (e.g. ad libitum): pelleted standard diet ad libitum
- Water (e.g. ad libitum): community tap water ad libitum. oce weekly additional supply of ascorbic acid approx 1g/L via drinking water
- Acclimation period: 1 week

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
25%, 15%, 10%, 5%
Induction 50, 25, 15 and 10%
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
25%, 15%, 10%, 5%
Induction 50, 25, 15 and 10%
Adequacy of challenge:
not specified
No. of animals per dose:
6 animals per dose and 6 animals as control group
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 20 applications
- Exposure period: 26 days (4 weeks)
- Test groups: Groups 2 to 5 (6 animals each)
- Control group: Group 1 (6 animals)
- Site:clipped right flank skin
- Frequency of applications:5 times per week
- Duration:4 weeks
- Concentrations:50, 25, 15, 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 72h
- Test groups: Groups 2 to 5 (6 animals each)
- Control group: Group 1 (6 animals)
- Site: right flank skin
- Concentrations: 25, 15, 10, 5 %
- Evaluation (hr after challenge): 24, 48, 72h
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5, 10, 15, 25%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5, 10, 15, 25%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5,10,15,25%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5,10,15,25%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
5,10,15,25%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 5,10,15,25%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
4
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
4
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
1
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Key result
Reading:
other: 1st,2nd,3rd reading (24,48,72h)
Group:
test group
Dose level:
5,10,15 %
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
Remarks on result:
other: see Remark
Remarks:
Reading: other: 1st,2nd,3rd reading (24,48,72h). Group: test group. Dose level: 5,10,15 %. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered to possess no skin sensitization (contact allergenic) potential in albino guinea pigs
Executive summary:

With the procedure used in this experiment, no difference between the test groups and the control group were evident after the challenge application of the test substance. The positive skin reactions and their intensity observed after the challenge at 25% correspond to the irritant potential of the test article determined before starting the induction (pretest). The test substance is therefore considered to possess no skin sensitization (contact allergenic) potential in albino guinea pigs