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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 05th, 1992 - July 24th, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance methyl linoleate (CAS No. 112-63-0). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
Methyl linoleate
EC Number:
203-993-0
EC Name:
Methyl linoleate
Cas Number:
112-63-0
IUPAC Name:
methyl octadeca-9,12-dienoate
Details on test material:
- Name of test material (as cited in study report): Linolsäure-Methylester
- Chemical denomination: octadecadienoic acid methyl ester
- Batch No. 89F0928
- Physical state: colourless liquid
- Content of active substance. 99 %
- Purity: 100 %
- Stability: stable for at least one year, unstable in atmospheric oxygen, light and heat
- Stability after taking a sample: one hour
- Storage: cool and dark
- Expiration date: April 1993

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany.
- Age at study initiation: approx 6 weeks
- Weight at study initiation: approx. 340 g
- Housing: 2-3 animals in Makrolon Type IV cages with standard softwood bedding
- Diet (ad libitum): Altromin Maintenance Diet 3022, Lage, Germany.
- Water (ad libitum): community tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Remarks:
DAB 9, batch 2933
Concentration / amount:
Induction: 40%
Challenge: 20 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Remarks:
DAB 9, batch 2933
Concentration / amount:
Induction: 40%
Challenge: 20 %
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:
In preliminary studies with 3 guinea pigs 40% dilution of the test substance was found to be the minimally irritating concentration and 20 % dilution was found to be the maximally non-irritating concentration.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h under occlusive conditions using a patch test chamber (van der Bend, INTERDERM bv)
- Test groups: 10 animals were treated with 0.08 mL TS per chamber
- Control group: 20 animals, vehicle only
- Site: left cranial sheared flank
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 40 %
The results of the 3rd induction was evaluated 1 and 24 hours after the end of exposure.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction
- Exposure period: 6 h under occlusive conditions
- Test groups: 10 animals, TS
- Control group: 10 animals, TS; additionally, a second control group of 10 animals was treated with olive oil alone in the first and second week after the challenge of the other groups in order to estimate the influence of the vehicle.
- Site: bilaterally to sheared caudal flanks
- Concentrations: 20 %
- Evaluation (hr after challenge): 24 and 48 h

Results and discussion

Positive control results:
A reliability check had been performed in May 1990 (TBD 900384)

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: 1st reading from the right flank
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 1st reading from the right flank. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 1st reading from the left caudal flank
Hours after challenge:
24
Group:
test chemical
Dose level:
20 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 1st reading from the left caudal flank. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 1st reading from the right flank
Hours after challenge:
24
Group:
negative control
Dose level:
20 %
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 1st reading from the right flank. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 1st reading from the left caudal flank
Hours after challenge:
24
Group:
negative control
Dose level:
20 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 1st reading from the left caudal flank. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 2nd reading from the right flank
Hours after challenge:
48
Group:
test chemical
Dose level:
20 %
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 2nd reading from the right flank. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 2nd reading from the left caudal flank
Hours after challenge:
48
Group:
test chemical
Dose level:
20 %
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 2nd reading from the left caudal flank. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 2nd reading from the right flank
Hours after challenge:
48
Group:
negative control
Dose level:
20 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 2nd reading from the right flank. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: 2nd reading from the left caudal flank
Hours after challenge:
48
Group:
negative control
Dose level:
20 %
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: 2nd reading from the left caudal flank. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: reading from the left caudal flank
Hours after challenge:
168
Group:
other: vehicle control group
Dose level:
0 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: reading from the left caudal flank. . Hours after challenge: 168.0. Group: other: vehicle control group. Dose level: 0 %. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.
Reading:
other: reading from the right flank
Hours after challenge:
168
Group:
other: vehicle control group
Dose level:
0 %
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
no abnormalities observed
Remarks on result:
other: Reading: other: reading from the right flank. . Hours after challenge: 168.0. Group: other: vehicle control group. Dose level: 0 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: no abnormalities observed.

Any other information on results incl. tables

All test animals and negative control animals were without any distinct dermal effects after challenge.

No deaths occurred and no significant differences in the gain of the body weight occurred.

All tested animals, negative control animals and additional animals receiving only treatment with olive oil (vehicle control group) showed weak to moderate dermal reactions. Thus, the test substance itself was proven to be a non-sensitizer on the skin of guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information