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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1999-03-15 until 1999-04-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to internationally accepted testing guideline, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes.

Test material

Constituent 1
Reference substance name:
Isofol 20 H
IUPAC Name:
Isofol 20 H
Constituent 2
Reference substance name:
alcohol mixture 1:1 of 2-Octyl-1-dodecanol and 2-Hexyl-1-tetradecanol
IUPAC Name:
alcohol mixture 1:1 of 2-Octyl-1-dodecanol and 2-Hexyl-1-tetradecanol
Details on test material:
- Name of test material: ISOFOL 20 H
- Molecular formula: C20H42O
- Molecular weight: 298
- Composition of test material: alcohol mixture 1:1 of 2-Octyl-1-dodecanol (CAS 5333-42-6) and 2-Hexyl-1-tetradecanol (no CAS-No.)
- Substance type: not mentioned
- Physical state: liquid
- Analytical purity: 98.1 %
- Impurities: not mentioned
- Lot/batch No.: Toe 9/033
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: Pure: approx. 24 months; In solvent: stable for at least 2 hours in water, PEG, CMC, organic solvents, DMSO, propylene glycol, corn oil
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 4-5 weeks
- Weight at study initiation: 301 - 311 g
- Housing: The animals were kept in groups in Terluran cages on altromin saw fiber bedding. max. group size 10 animals
- Diet: ad libitum, Altromin 3122 maintenance diet for guines pigs, rich in crude fiber, totally-pathogen-free-TPF
- Water: ad libitum, drinking water, municipal residue control, microbiol. controlled periodically
- Acclimation period: not mentioned


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
- Concentrations used for induction: intradermal treatment: 100 %; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Concentrations used for challenge: 100 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
- Concentrations used for induction: intradermal treatment: 100 %; dermal treatment: 100 %
- Concentration in Freunds Complete Adjuvant (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Concentrations used for challenge: 100 %
No. of animals per dose:
test group: 10 animals
control group: 5 animals
Details on study design:
RANGE FINDING TESTS: Yes, Three animals were topically treated with different concentrations of the test item.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 ml); 2nd exposure: epicutaneous for 48 hours; evaluation after 1 and 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): 50 % test substance in a mixture of FCA and 1:1 diluted with isotonic saline
- Test group: dermal: 100 % test substance applied to the test area and held in contact by an occlusive dressing
- Control group: Cottonseed Oil
- Frequency of applications: day 0: intradermal treatment, day 6: pretreatment with 0.5 ml sodium lauryl sulphate (10% in vaseline) and day 7: dermal treatment
- Duration: 3 weeks
- Concentrations: 100 % test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 21
- Exposure period: dermal application for 24 hours
- Test groups: test substance
- Control group: Cottonseed Oil
- Site: test substance of the left flanks, control group to the right flanks (intrspecific control)
- Concentrations: 100 %
- Evaluation (hr after challenge): 24, 48 and 72 hours after application
Challenge controls:
see above B. Challenge exposure
Positive control substance(s):
yes
Remarks:
reliability checks were performed in Feb/Mar 1999 with Mercaptobenzothiazole (CAS 149-30-4)

Results and discussion

Positive control results:
Frequency of sensitisation at 24 h 70%, at 48 h 70% and at 72 h 60%.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
15 %
No. with + reactions:
7
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
15 %
No. with + reactions:
7
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
positive control
Dose level:
15 %
No. with + reactions:
6
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The sensitisation rate after application of the test substance was 0 %. Under the test conditions described below the mixture of 2-octyldodecan-1-ol and 2-hexyltetradecan-1-ol is not sensitising.