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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:
1997
Report Date:
1997

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
Justification for non-LLNA method:
A skin sensitization study in guinea pigs is available for KGA. No signs of irritation were seen in any animals during the challenge phase.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPoc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Age at study initiation: About 5 weeks
- Weight at study initiation: 340-399 grams
- Housing: The guinea pigs were housed in a Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 60-87%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: June 05, 1997 To: July 25, 1997

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Aqua pro Injectione
Concentration / amount:
50%
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Aqua pro Injectione
Concentration / amount:
50%
No. of animals per dose:
10 in the negative control group; 20 in the test material group
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 1
- Site: Shoulder
- Frequency of applications: Intradermal injection on day 1 (50 g/L); Topical application on day 8 (100 g/L)
- Duration: 8 days

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 3
- Exposure period: 48 hours, 72 hours
- Test groups: 1
- Control group: 1
- Site: Shoulder
- Concentrations: 10 g/L
- Evaluation (hr after challenge): 72 hours
Challenge controls:
Aqua pro injectione
Positive control substance(s):
yes
Remarks:
Aqua pro injectione

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
other: Weak sensitizer
Conclusions:
According to Magnusson and Kligman, the test material has been classified as a weak sensitizer, which corresponds to a sensitization rate of 0-8%.
Executive summary:

This study examined the potential of the test substance to cause sensitization to skin. A group of 20 female guinea pigs were exposed to a concentration of 50% of test substance. 20 female guinea pigs were used as controls. The induction phase consisted of two intradermal injections followed by dermal application. Seven (7) days later, the animals were challenged by dermal application. No signs of irritation were seen in any animals during the challenge phase. The test substance is not sensitising to skin, but is considered to be a weak sensitizer according to Magnusson and Kligman.