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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
9/1994-11/1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Please see Analogue Approach
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The test was performed before the LLNA method existed.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Borchen, Germany
- Age at study initiation: young adults, no further details mentioned
- Weight at study initiation: < 500 g
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet (e.g. ad libitum): Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 26.09.1994 To: 4.10.1994 (preliminary study)
From: 4.10.1994 To: 4.11.1994 (main study)
Route:
epicutaneous, occlusive
Vehicle:
other: deionised water
Concentration / amount:
2,5 %; 25 %; 50 %; 100 %
Route:
epicutaneous, occlusive
Vehicle:
other: deionised water
Concentration / amount:
2,5 %; 25 %; 50 %; 100 %
No. of animals per dose:
test animals: 20 (main experiment), 3 (pilot study), 3 (determination of challenge concentration)
control animals: 10
Details on study design:
RANGE FINDING TESTS:
Determination of the non-irritant concentration of the test substance with occlusive epicutaneous applications for 6 hours of test substance 5%, 25% and 50% in VE-water and 100% (undiluted). Readings at 30 and 54 hours after start of application.
Redetermination of the maximum non-irritant concentration for the challenge treatment in the 4th week with 3 additional guinea pigs which had not been treated up to this time. The concentrations and test conditions were the same as in the pilot study. This additional testing was carried out because it was suspected that the sensitivity of the skin changed as the weight of the animals increased. This ensured that the challenge concentration was determined on animals which had approx. the same weights as the 30 animals in the challenge phase.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: occlusive dermal applications for 6 hours, scoring at 30 hours after start of application
- Test group: receiving test substance (0.3 cm³/patch)
- Control group: receiving vehicle (0.3 cm³/patch)
- Site: left flanks
- Frequency of applications: induction on days 0, 7 and 14
- Duration: 3 weeks
- Concentrations: 2,5; 25; 50 %-ig in VE-water and 100 %


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28
- Exposure period: occlusive dermal application for 6 hours
- Test groups: receiving test substance solution and vehicle (0.3 cm³/patch each)
- Control group: receiving test substance solution and vehicle (0.3 cm³/patch each)
- Site: right flanks (front: vehicle, back: test substance solution)
- Concentrations: 100 %
- Evaluation (hr after challenge): 30 and 54 hours after application


Challenge controls:
same treatment as test group animals
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazol
Reading:
1st reading
Hours after challenge:
30
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Key result
Reading:
2nd reading
Hours after challenge:
54
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
30
Group:
positive control
Dose level:
50 % SA
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: positive control. Dose level: 50 % SA. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Erythema.
Reading:
2nd reading
Hours after challenge:
54
Group:
positive control
Dose level:
50 % SA
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: positive control. Dose level: 50 % SA. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Erythema.
Interpretation of results:
GHS criteria not met
Conclusions:
The read-across substance Coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate was investigated according to the Bühler-method with 20 test-animals and 10 control-animals. The dermal application during induction I, II and III lead not to irritation. After challenge with the undiluted test-substance no erythema or oedema were observed after 30 h and 54 h. Under the test conditions coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate showed no skin sensitation potential for guinea -pigs.
Executive summary:

The read-across substance Coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate was investigated according to the Bühler-method with 20 test-animals and 10 control-animals. The dermal application during induction I, II and III lead not to irritation. After challenge with the undiluted test-substance no erythema or oedema were observed after 30 h and 54 h. Under the test conditions coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate showed no skin sensitation potential for guinea -pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The read-across substance Coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate was investigated according to the Bühler-method with 20 test-animals and 10 control-animals. The dermal application during induction I, II and III lead not to irritation. After challenge with the undiluted test-substance no erythema or oedema were observed after 30 h and 54 h. Under the test conditions coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate showed no skin sensitation potential for guinea -pigs. It is likely that also the test substance is not skin sensitising because of the structural similarity (Please see Analogue Approach).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.