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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:
01 Feb - 22 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (no analysis of the test substance, no data on positive controls, challenge on both flanks)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buehler Test
Deviations:
yes
Remarks:
no analysis of the test substance, no data on positive controls, challenge on both flanks
GLP compliance:
yes
Type of study:
Buehler 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
Details on test material:
- Name of test material (as cited in study report): fatty acids, C16-18 and C18 unsatured, triesters with trimethylol propane
- Physical state: liquid, yellow
- Analytical purity: 100%
- Lot/batch No.: 3381
- Expiration date of the lot/batch: July, 1995
- Storage condition of test material: at room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white; Hsd/Win:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: approx. 345 g (main study)
- Housing: groups of 2-3 animals in Makrolon Type IV cages
- Diet: pelleted Altromin Maintenance Diet 3022, Batch No. 020494/1337 and 020794/1616; Altromin GmbH, Lage, Germany, ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12 / 12 (music during light hours)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
100% for both, induction and challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
100% for both, induction and challenge
No. of animals per dose:
10 (controls), 20 (test groups)
Details on study design:
RANGE FINDING TESTS: Yes
Evaluation of dermal effects was done by treating 3 animals with vehicle, 12.5%, 25%, 50% or 100% of the test substance and observation of irritating effects 24 h and 48 h after treatment.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: peanut oil
- Site: left cranial sheared flank
- Frequency of applications: once a week
- Duration: Days 0-14
- Concentrations: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 6 h
- Test groups: test substance
- Control group: test substance
- Site: both shared flanks (caudal)
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 h
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No effects on both flanks
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No effects on both flanks.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight dermal effects on the right flank
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects on the right flank.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight dermal effects on the left flank
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects on the left flank.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight dermal effects on the right flank
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight dermal effects on the right flank.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
slight dermal effects on the left flank
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: slight dermal effects on the left flank.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight dermal effects on the right flank
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects on the right flank.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight dermal effects on the left flank
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects on the left flank.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight dermal effects on the right flank
Remarks on result:
other: Reading:
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight dermal effects on the left flank
Remarks on result:
other: Reading:
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects on both flanks
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
CLP: not classified
DSD: not classified