Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
1 Feb - 22 Apr 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions; 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:
adopted in 1992
Deviations:
yes
Remarks:
no data on positive controls, challenge on both flanks
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study conducted prior to LLNA validation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Substance type: 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: Room temperature, 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; carrots were optionally added
- 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:
20 animals in treatment group and 10 animals in control group
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. Since no skin reaction was seen at all tested concentrations up to 100%, the test substance was used as 100% for induction and further for challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: left cranial sheared flank
- Frequency of applications: once a week
- Duration: 3 weeks, application once a week
- Concentrations: 100%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 6 h
- Test groups: 1 (20 animals received 100% of test substance))
- Control group: 1 (10 animals received 100% of test substance)
- Site: both shared flanks (caudal)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 h, 48 h, 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:
1
Total no. in group:
20
Clinical observations:
1 animal showed slight reaction, both on the left (induced) and right (non-induced) side
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed slight reaction, both on the left (induced) and right (non-induced) side.
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 and left flank in 1 animal
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 and left flank in 1 animal.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
5 animals showed slight reaction, both on the left (induced) 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: 5 animals showed slight reaction, both on the left (induced) 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 in 1 animal
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 in 1 animal.
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:
1 animal showed slight reaction, both on the left (induced) and right (non-induced) side
Remarks on result:
other: see Remark
Remarks:
Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed slight reaction, both on the left (induced) and right (non-induced) side.
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
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No effects.

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