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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Comparable to guideline study with acceptable restrictions. Lack of test material details.
Justification for type of information:
Please refer section 13 for read across justification.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Comparable to guideline study with acceptable restrictions. Lack of test material details.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of test material details
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
A non-LLNA study was available.
Species:
guinea pig
Strain:
other: Pirbright
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH&Co. KG, Extertal, Germany
- Weight at study initiation: 269 g
- Housing: Groups of 2 animals in Macrolon Plastic cages III (measuring 14 x 25 x 42 cm) with Saniff bedding.
- Diet: pelleted, Alleindiät für Meerschweinchen (Plange Kraftfutterwerk Soest GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Preliminary study: 25, 50, 75 and 100%
Main study:
Induction: 100% (test substance mixed with a few drops of water)
Challenge: 100%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Preliminary study: 25, 50, 75 and 100%
Main study:
Induction: 100% (test substance mixed with a few drops of water)
Challenge: 100%
No. of animals per dose:
10 (controls), 20 (test group)
Details on study design:
RANGE FINDING TESTS:
In a preliminary test with 25, 50, 75 and 100% (w/v) of the test substance in water no irritation was noted after 6 h occlusive exposure. Therefore, the test article was applied as 100% (w/v) in a few drops of dest. water.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in dest. water
- Control group: untreated
- Site: shaved left shoulder
- Frequency of applications: every week
- Duration: Day 0-21
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 35
- Exposure period: 6 h
- Test groups: test substance
- Control group: test substance
- Site: shaved right shoulder
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 h

OTHER: 24 h after the challenge all animals were depilated with Pilca Cream (Olivin, Hamburg, Germany).
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Clinical observations:
-
Remarks on result:
not measured/tested
Remarks:
not measured
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
72
Group:
positive control
Remarks on result:
not measured/tested

The test substance caused no skin reactions in the preliminary and in the main study in any animal during the study period.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance caused no skin reactions in the preliminary and in the main study in any animal during the study period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of test material details
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
A non-LLNA study was available.

Test material

Constituent 1
Chemical structure
Reference substance name:
1-methyl-1,2-ethanediyl dioleate
EC Number:
203-315-3
EC Name:
1-methyl-1,2-ethanediyl dioleate
Cas Number:
105-62-4
Molecular formula:
C39H72O4
IUPAC Name:
1-methyl-1,2-ethanediyl dioleate
Details on test material:
- Name of test material (as cited in study report): 1-Methyl-1,2-ethanediyl dioleate
- Analytical purity: no data
- Lot/batch No.: CH 190206/001
- Other: CAS Number 105-62-4; EC Number 203-315-3

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH&Co. KG, Extertal, Germany
- Weight at study initiation: 269 g
- Housing: Groups of 2 animals in Macrolon Plastic cages III (measuring 14 x 25 x 42 cm) with Saniff bedding.
- Diet: pelleted, Alleindiät für Meerschweinchen (Plange Kraftfutterwerk Soest GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Preliminary study: 25, 50, 75 and 100%
Main study:
Induction: 100% (test substance mixed with a few drops of water)
Challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Preliminary study: 25, 50, 75 and 100%
Main study:
Induction: 100% (test substance mixed with a few drops of water)
Challenge: 100%
No. of animals per dose:
10 (controls), 20 (test group)
Details on study design:
RANGE FINDING TESTS:
In a preliminary test with 25, 50, 75 and 100% (w/v) of the test substance in water no irritation was noted after 6 h occlusive exposure. Therefore, the test article was applied as 100% (w/v) in a few drops of dest. water.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in dest. water
- Control group: untreated
- Site: shaved left shoulder
- Frequency of applications: every week
- Duration: Day 0-21
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 35
- Exposure period: 6 h
- Test groups: test substance
- Control group: test substance
- Site: shaved right shoulder
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 h

OTHER: 24 h after the challenge all animals were depilated with Pilca Cream (Olivin, Hamburg, Germany).
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Clinical observations:
-
Remarks on result:
not measured/tested
Remarks:
not measured
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
-
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
72
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

The test substance caused no skin reactions in the preliminary and in the main study in any animal during the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance caused no skin reactions in the preliminary and in the main study in any animal during the study period.