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Diss Factsheets

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed for none EU registrations.

Test material

Constituent 1
Reference substance name:
Alcohols, C18-22, distn. residues
EC Number:
641-136-6
Cas Number:
1160164-88-4
IUPAC Name:
Alcohols, C18-22, distn. residues
Details on test material:
- Name of test material (as cited in study report): Alcohols C18-22, distn. residues
- Substance type: pure active substance
- Physical state: solid
- Storage condition of test material: at room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Hdq: Wilmington, MA, USA
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: 331 - 403 g (males; 320 - 380 g (females)
- Housing: 1 - 5 animals per cage, males separate from females (cage type: suspended, wire bottom, stainles steel); housed individually for 3 days during wrapping
- Diet: PMI Feeds, Inc. Guinea Pig Diet ad libitum
- Water: Municipal water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -21
- Humidity (%): 47 - 92 (relative humidity was outside protocol range)
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2009-10-04 To: 2009-10-31

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
4 % v/v solution of test substance in vehicle with and without adjuvant (50:50 v/v) for intradermal injections; 10 % w/v in vehicle for epicutaneous and challenge applications
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
4 % v/v solution of test substance in vehicle with and without adjuvant (50:50 v/v) for intradermal injections; 10 % w/v in vehicle for epicutaneous and challenge applications
No. of animals per dose:
10 animals per sex for the test group, 5 per sex for the control group; 3 per sex for range finding
Details on study design:
RANGE FINDING TESTS:
Intradermal testing: 1 , 2, 4 and 5 % v/v in corn oil at 1 male and 1 female animal (left and right flanks); dose amount 0.1 mL; evaluation after 24 and 48 hours
Topical application: 1, 5, 10 and 25 % w/v in petrolatum at 2 male and 2 female animals (left and right flanks); dose amount 0.5 g; evaluation after 48 hours


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period:
Intradermal: single injections
Epicutaneous: 48 hours, evaluation 24 hours after patch removal
- Test groups:
Intradermal: 3 pairs of symmetrical intradermal injections (0.1 mL each). Injections sites 1&2: Freund's Complete Adjuvant - 50% v/v in saline; injection sites 3&4: test substance 4% (v/v) in corn oil; injection sites 5&6: Mixture (50:50) of Freund's Complete Adjuvant in saline and test substance in corn oil
Epicutaneous: 0.5 mL of 10% w/v of test substance in corn oil
- Control group:
Intradermal: The control animals received the same injections as the test group animals with the vehicle substituted for the test substance in the second and third pairs of injections.
- Site:
Intradermal: on the upper back of each animal within a 4x6 cm exposure area running laterally across the shoulders, clipped free of hairs; injections sites 1&2: one on each side of the spinal column and approx. 3.5 cm apart; injection sites 3&4: approx. 0.5 cm behind the first pair of injections; injection sites 5&6: approx. 0.5 cm behind the second pair of injections; all injections were within a 2x4 cm area of the 4x6 cm exposure area
Epicutaneous: applied to the exposure area to cover the intradermal injection sites (a 25 mm glass fiber filter patch was used to cover the dose site, the patch was then occluded with an adhesive masking tape and secured in place with an elastic adhesive wrap)
- Frequency of applications: Intradermal injections at day 0, epicutaneous application on day 7
- Duration: 3 weeks
- Concentrations:
Intradermal: 4% (v/v) in corn oil
Epicutaneous: 10% w/v in corn oil


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Test groups: 0.5 mL test substance in corn oil applied topically to the right flank; 0.5 mL of 50:50 corn oil:petrolatum applied topically to the left flank (a 25 mm glass fiber filter patch was used to cover the dose sites, secured as in the induction exposure)
- Control group: same treatment as test group animals
- Concentrations: 10% w/v in corn oil
- Evaluation (hr after challenge): 48 and 72 hours (24 and 48 hours after patch removal)
Challenge controls:
see above
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde 85%

Results and discussion

Positive control results:
All positive control animal exhibited moderate to intense erythema after the challenge treatment (concentrations administered: 25% v/v solution of positive control substance in safflower oil with and without adjuvant (50:50 v/v) for intradermal injections; undiluted positive control substance for topical and challenge applications). None of the animals of the naive control group exhibited erythema after the challenge treatment.
The positive control substance was considered an extreme sensitizer and confirmed the sensitivity of the used strain of guinea pigs.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% w/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
85%
No. with + reactions:
9
Total no. in group:
9
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
85%
No. with + reactions:
9
Total no. in group:
9

Any other information on results incl. tables

A pre-test screen with 3 animals/sex was conducted to determine induction concentration producing no more than moderate irritation, and a maximum non-irritation challenge concentration. Based on screen results, a 4% v/v solution of test substance in corn oil was selectied for intradermal injection, and a 10% w/v concentration of test substance in corn oil was selected for the topical applications (induction and challenge).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The challenge treatments with either vehicle alone or test substance in vehicle produced no erythema in any of the test and or control group animals. Body weight gain was unaffected by the administration of the test substance. Since none of the test animals exhibited scores greater than 0, the test substance Alcohols, C18-22, distn. residues was given a sensitization potency rating of non-sensitizing (Grade 0).
Executive summary:

A maximization test for topically applied test substances was conducted on 30 short-haired male and female albino guinea pigs using the methods of Magnusson and Kligman according to the OECD Guideline of the Testing of Chemicals No. 406 "Skin Sensitisation", adopted on 17th July 1992.

The test substance was warmed for use in the intradermal portions of the study. Test group animals (10/sex) received three pairs of intradermal injections (adjuvant, a solution of test substance in corn oil, and a 50:50 mixture of adjuvant and the test substance solution) followed one week later by a single topical application of the test substance in corn oil. Ten additional animals (5/sex) served as a control group. Control animals were treated at the same time periods and locations but with the vehicle used in place of the test substance solution. Two weeks after the topical application, the test animals were challenged with a second topical application of the tes substance in corn oil. The percentage of animals exhibiting erythema with or without edema after the challenge treatment was used to assign the test substance a sensitization potency rating. Since none of the test animals exhibited scores greater than 0, the test substance Alcohols, C18 -22, distn. residues was given a sensitization potency rating of non-sensitizing (Grade 0).