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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
Study period:
09 Mar - 30 Apr 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no rationale for used concentrations given, limited etails on test substance purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
analytical purity of test substance not specified, no range finding for irritation, thus no explanation for used concentrations of 5% for intra- and epidermal induction, 25% for challenge
Principles of method if other than guideline:
Magnusson and Kligman method in guinea pigs
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Züchter Winkelmann, Borchen
- Weight at study initiation: test group mean: 382 g; control group mean: 337 g
- Housing: 5 per cage
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50 - 56
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Carboxymethylcellulose, Cremophor
Concentration / amount:
5% for injection
5% for dermal induction
25% for dermal challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Carboxymethylcellulose, Cremophor
Concentration / amount:
5% for injection
5% for dermal induction
25% for dermal challenge
No. of animals per dose:
15 for treatment, 19 as control
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: injection on day 1, epidermal application on day 7
- Test groups: 3 injections: 0.1 mL Freund's adjuvant, 0.1 mL 5% test substance in 2% Carboxymethylcellulose and 0.5% Cremophor, 0.1 mL Freund's adjuvant with test substance 1:1, concentration 5%; epidermal application: 5% in Vaseline
- Control group: the same than test group without test substance
- Site: two rows with 3 injections right and left of the scapular midline, dermal application on the injections sites
- Frequency of applications: 1
- Duration: single injections and 48 h dermal exposure under occlusive conditions
- Concentrations: 5%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after dermal induction (day 22)
- Exposure period: 24 h
- Test groups: 0.1 mL 25% test substance in 2% Carboxymethylcellulose and 0.5% Cremophor
- Control group: 0.1 mL 2% Carboxymethylcellulose and 0.5% Cremophor
- Site: test substance on the right flank, vehicle on the left
- Concentrations: 25% and vehicle only
- Evaluation (hr after challenge): 48 and 72 h

Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
none
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

The test substance is not sensitising to the skin of guinea pigs, when used as 5% solution for induction and 25% solution for challenge.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified