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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:
1978
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:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(no data on any reliability check performed)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Alcohols, C12-13
EC Number:
278-306-0
EC Name:
Alcohols, C12-13
Cas Number:
75782-86-4
IUPAC Name:
dodecan-1-ol
Details on test material:
- Name of test material (as cited in study report): Dobanol 23 (C10-16 alcohols Type C)
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C12-C13 chain length synthetic primary fatty alcohol
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 118 ex Tank 4611
- 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:
other: 'P' strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Breeding Unit, Sittingbourne, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: no data
- Housing: 5 per cage in stainless steel cages with mesh floors and tops and half mesh fronts
- Diet (e.g. ad libitum): conventional with vitamin C supplement; ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5%
- Air changes (per hr): 15
- 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:
corn oil
Concentration / amount:
1st application: Induction 0.05 % intradermal
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1st application: Induction 0.05 % intradermal
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
No. of animals per dose:
10/sex - treatment group
5/sex - control group
Details on study design:
RANGE FINDING TESTS: yes, to determine concentrations for main test: maximum concentration for injection without causing toxicity; epicutaneous concentration just causing irritation for induction; concentration for challenge which was just nonirritating.

MAIN STUDY
A. INDUCTION EXPOSURE - intradermal
- No. of exposures: 1
- Exposure period: not applicable
- Test groups: three paired injections (0.01 ml): Freund's Complete Adjuvant, test material in corn oil, test material in 50:50 corn oil:Freund's Complete Adjuvant
- Control group: Freund's Complete Adjuvant, corn oil, 50:50 corn oil:Freund's Complete Adjuvant
- Site: shoulder region, each side of midline
- Frequency of applications: once
- Duration: day 1
- Concentrations: 0.05%

A. INDUCTION EXPOSURE - epicutaneous
- No. of exposures: 1
- Exposure period: 48 hr
- Test groups: test material in corn oil
- Control group: corn oil
- Site: over injection site
- Frequency of applications: once
- Duration: day 8-10
- Concentrations: 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22-23
- Exposure period: 24 hr
- Test groups: test material in corn oil
- Control group: test material in corn oil
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): immediately, 24 and 48 hr
Challenge controls:
yes
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
none

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
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: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
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: 25%. 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:
25%
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: 25%. 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:
25%
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: 25%. 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, carried out using a protocol similar to OECD guideline 406 (Magnusson and Kligman maximization test) Dobanol 23 (C12-C13 chain length synthetic primary fatty alcohol) did not induce sensitization in male and female guinea pigs.