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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:
key study
Study period:
no data (report year is 1984)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

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:
(some details missing from report)
Principles of method if other than guideline:
Magnusson & Kligman maximization test
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lial 145 (C14-16 alcohols Type A). Equivalent to alcohols, C14-15-branched and linear (no CAS)
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Padre Antonio, Mariano Comense, CO, Italy
- Age at study initiation: no data
- Weight at study initiation: 250-300 g
- Housing: 5 animals per polycabonate cage with sawdust bedding
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 55 +/- 15
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: where FCA was used the test material was dissolved in this. It is unclear what vehicle was used for the injection without FCA or for epicutaneous induction
Concentration / amount:
Intradermal induction: 0.1 g (or 0.1 ml; both terms are used in the report)
Epicutaneous induction: 0.5 g (or 0.5 ml)
Challenge: 1.0 g (or 1.0 ml)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: where FCA was used the test material was dissolved in this. It is unclear what vehicle was used for the injection without FCA or for epicutaneous induction
Concentration / amount:
Intradermal induction: 0.1 g (or 0.1 ml; both terms are used in the report)
Epicutaneous induction: 0.5 g (or 0.5 ml)
Challenge: 1.0 g (or 1.0 ml)
No. of animals per dose:
20 in treated group
10 in control group
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL INJECTION
- No. of exposures: 1
- Test groups: 3 pairs of injections - Freund's Complete Adjuvant, test material emulsified in Freund's Complete Adjuvant; test material (in vehicle ?)
- Control group: 3 pairs of injections - Freund's Complete Adjuvant, (vehicle in?) Freund's Complete Adjuvant; vehicle ? (Where FCA was used the test material was dissolved in this. It is unclear what vehicle was used for the injection without FCA or for epicutaneous induction.)
- Site: dorsal region
- Frequency of applications: once
- Duration: day 0
- Concentrations: 0.1 ml (or 0.1 g, both terms are used in the report)

EPICUTANEOUS APPLICATION
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: test material (it is unclear whether a vehicle was used)
- Control group: it is unclear whether the control group received an application of vehicle
- Site: dorsal region just behind injection site
- Frequency of applications: once
- Duration: day 7-9 (on day 6 the animals were treated with 10% sodium lauryl sulphate in petrolatum to induce mild irritation)
- Concentrations: 0.5 ml (or 0.5 g, both terms are used in the report)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: days 20-21
- Exposure period: 24 hours
- Test groups: 0.5 ml of the test material applied to each flank
- Control group: 0.5 ml of the test material applied to each flank
- Site: flanks
- Concentrations: total per animal 1.0 ml (or 1.0 g, both terms are used in the report)
- Evaluation (hr after challenge): immediately after removal of the patch and 24 and 48 hours later
Challenge controls:
Control (non-induced) animals were treated with 0.5 ml of the test material on each flank region (total applied 1.0 ml)
Positive control substance(s):
not required

Study design: in vivo (LLNA)

Statistics:
not applicable, negative result

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1.0 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1.0 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1.0 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1.0 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none reported.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a reliable study conducted using a protocol similar to OECD guideline 406, Lial 145 (C14-16 alcohols Type A) was not a skin sensitiser in guinea pigs (maximization procedure of Magnusson & Kligman).