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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:
weight of evidence
Study period:
March 11, 1980 - April 04, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed similar to OECD 406 guideline. Non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive control, 2nd challenge quickly after 1st challenge with lower concentration.
Principles of method if other than guideline:
The test was mainly conducted according to the method described by Magnusson and Kligman, "Allergic contact dermatitis in guinea pigs", Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970).
GLP compliance:
no
Remarks:
not present at the time of performance.
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA method not available at time of testing

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
EC Number:
255-138-6
EC Name:
3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
Cas Number:
40910-49-4
Molecular formula:
C14H26O2
IUPAC Name:
3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Elintaal F
- Description: Slightly yellow liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino SPF
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the breeding of laboratory animals TNO, Zeist, The Netherlands
- Age at study initiation: young male animals
- Weight at study initiation: 300 - 415 g
- Housing: Individually housed in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: Pelleted stock diet (Hope Farms, Woerden, The Netherlands) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 - 25
- Humidity (%): 40 -70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
5% for the intradermal induction and 10% for the epidermal induction.
10% and 5% for the challenge phase.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
5% for the intradermal induction and 10% for the epidermal induction.
10% and 5% for the challenge phase.
No. of animals per dose:
Test animals: 10
Control animals: 5
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1

1) Intradermal injections on day 1:
- Site: shoulder region shaved with electric clippers
Three pairs of intradermal injections:
1) 0.05 mL: Freund's Adjuvant
2) 0.05 mL: test substance at a 5% concentration (control animals: 0.05 mL propylene glycol)
3) 0.05 mL: 1:1 mixture of 5% concentration of the test substance Freund's Adjuvant

2) Topical application on day 8:
- Site: shoulder region shaved with electric clippers
- Amount: 10% test substance dilution in vaseline
- Area: approximately 8 cm^2
- Exposure period: 48 hours (occlusive)

B. CHALLENGE EXPOSURE
- Day of challenge: day 21, all animals, with the 10% test substance mixed with vaseline
- Exposure period: 24 hours (occlusive)
- Site: right flank
- Amount: gently massaged in with a glass rod
- Readings: 24 hours after patch removal

RECHALLENGE: day 23, all animals, with the 5% test substance mixed with vaseline

OBSERVATIONS
Skin reactions were judged by the method of Draize, as described in J. Pharmacol. 82 (1944) 377-390
Challenge controls:
Not applicable.

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 chemical
Dose level:
10%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Preliminary test:

A concentration of 5% was chosen for intradermal induction, because this concentration induced only moderate irritation.

A concentration of 10%, which proved to be non-irritating in the topical induction, was used for the challenge.

Main test:

The intradermal injections given in the induction phase resulted in:

- FCA: erythema and edema;

- 5% test substance in propylene glycol: slight erythema and abscesses;

- 5% test substance in propylene glycol + FCA: slight erythema, slight edema and abscesses

The 10% concentration in vaseline induced neither erythema nor edema upon topical application in the induction phase.

In the first challenge, the 10% concentration provoked very slight erythema in 3 animals in the test group. The control animals showed no reaction.

The 5% concentration in the rechallenge showed no reaction in the test animals or in the control animals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guinea pig maximisation test method the potential of Elintaal F for skin sensitisation was tested similar to OECD 406 guideline, showing very slight erythema in 3 out of 10 animals. At the 5% challenge concentration, no sensitization properties were observed.
Executive summary:

In a guinea pig maximisation test method the potential of Elintaal F for skin sensitisation was tested similar to OECD 406 guideline.

The intradermal injections (5% test substance concentration) given in the induction phase resulted in slight erythema, slight edema and abscesses. The 10% concentration in vaseline induced neither erythema nor edema upon topical application in the induction phase.

In the first challenge, the 10% concentration provoked very slight erythema in 3 animals in the test group. The control animals showed no reaction. The 5% concentration in the rechallenge showed no reaction in the test animals or in the control animals.