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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available, no individual data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
5 male guinea pigs were tested for the sensitising potential of the test substance by intradermal induction and intradermal challenge treatment. The experimental design is similar to the "Draize test" stated in OECD guideline 401 (adopted 1981), with the restriction that only 5 animals per group were used.
GLP compliance:
no
Type of study:
intracutaneous test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): trade name only given
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White W58
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 275 g (mean)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
Induction: 25%
Challenge: 25%
Challengeopen allclose all
Route:
intradermal
Vehicle:
olive oil
Concentration / amount:
Induction: 25%
Challenge: 25%
No. of animals per dose:
5
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 (intradermal)
- Exposure period: single injection (intradermal)
- Test group: 1 pair of injections of 25% test substance (0.1 mL/site), one injection on each side of the back
- Control group: 1 pair of injections with olive oil (0.1 mL/site), one injection on each side of the back
- Site: paravertebral area
- Frequency of applications: eyery second day
- Duration: Days 1-19
- Concentrations: 25%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 33 (14 days after the last induction exposure)
- Exposure period: single intradermal injection
- Test groups: 1 pair of injections of 25% test substance (0.1 mL/site), one injection on each side of the back
- Control group: 1 pair of injections with olive oil (0.1 mL/site), one injection on each side of the back
- Concentrations: 25%
Challenge controls:
The control group is a challenge control
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

The induction caused slight redness at the injection sites 24 hours after the treatment. This effect was fully reversible within 2 days.

Following the challenge, no differences in skin reactions between control and test group were observed.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU