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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:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
modified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study predates the LLNA test guideline (OECD 429). The study is rated reliability 1 (Klimisch et al, 1997), and was conducted to GLP standards. Reproducing this endpoint using the LLNA test guideline is considered to be scientifically not necessary.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright (Tif: DHP) White strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: ca. 10 weeks old
- Weight at study initiation: 323 - 446 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG
- Water (e.g. ad libitum): ad libitum fresh water, supplemented with fresh carrots.
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Induction: 10 % in vaseline ; ca. 0.4 g per patch
Challenge: 10 % in vaseline; ca. 0.2 g per patch
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Induction: 10 % in vaseline ; ca. 0.4 g per patch
Challenge: 10 % in vaseline; ca. 0.2 g per patch
No. of animals per dose:
10 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: First induction week = 24 hours; Second induction week = 48 hours
- Site: 4 sites on the animal's neck.
- Frequency of applications: once per week
- Concentrations: First induction week = 0.1 ml of a freshly prepared adjuvant saline mixture; Second induction week = 10 % test compound in vaseline; ca. 0.4 g per patch
- Control group: treated with adjuvant and the vehicle during the induction period

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Site: untreated contralateral flanks of the animals
- Concentrations: 10 % test compound in vaseline; ca. 0.2 g per patch
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal sub irritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induction: negative control (vehicle), Challenge: test compound
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction: negative control (vehicle), Challenge: test compound. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induction: test compound; Challenge: negative control (vehicle)
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction: test compound; Challenge: negative control (vehicle). Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induction: negative control (vehicle); Challenge: test compound
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction: negative control (vehicle); Challenge: test compound. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induction: test compound; Challenge: negative control (vehicle)
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction: test compound; Challenge: negative control (vehicle). Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material failed to induce sufficent skin sensitisation to be considered a skin sensitiser.