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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Buehler-Test with 20 animals which were induced by three 6 h applications within three weeks. Two weeks later the challenge application was done.
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 40% ethanol for induction; acetone for challenge
Concentration / amount:
Induction: 5%
Challenge: 5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 40% ethanol for induction; acetone for challenge
Concentration / amount:
Induction: 5%
Challenge: 5%
No. of animals per dose:
Test group: 20
Control group: 10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: once a week for three weeks
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after last induction
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 10 animals
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 hours after application

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
an occasional very slight degree of irritation was seen
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: an occasional very slight degree of irritation was seen.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
an occasional very slight degree of irritation was seen
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: an occasional very slight degree of irritation was seen.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
an occasional very slight degree of irritation was seen
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: 10.0. Clinical observations: an occasional very slight degree of irritation was seen.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
an occasional very slight degree of irritation was seen
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: 10.0. Clinical observations: an occasional very slight degree of irritation was seen.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information