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Description of key information

Skin sensitisation (OECD 406): not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 SEP - 27 OCT 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dunkin Hartley
- Age at study initiation: 12 weeks
- Weight at study initiation: 329-427g
- Housing: singly or in pairs in solid-floor
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Intradermal Induction: 1% w/v in arachis oil BP
Topical Induction: undiluted as supplied
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Topical Challenge: 50% and 25% v/v in arachis BP
No. of animals per dose:
Intradermal Induction: two animals receiving four 0.1 ml injections
Topical Induction: two animals were treated with the undiluted test material and three preparations of the test material
Topical Challenge: two animals per undiluted test material and three preparations of the test material
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: the degree of erythema and oedema was quantified 1 and 24 hours following removal of the patches
- Control group: a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) arachis oil BP
c) a 50% w7v formulation of arachis oil BP in Freund's Complete adjuvant/distilled water 1:1
- Site: shoulder region
- Duration: 7 days
- Concentrations: 3 injections (0.1 ml each)
a)Freund's Complete adjuvant plus distilled water in the ratio 1:1
b) a 1% w/v formulation of the test material in arachis oil BP
c) a 1% w/v formulation of the test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water

B. CHALLENGE EXPOSURE
- Day(s) of challenge: 21 days
- Site: shorn right flank
- Concentrations: 25% and 50% v/v in arachis oil BP
- Evaluation (hr after challenge): 24 h
Positive control substance(s):
yes
Remarks:
historical data
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Animals Number skin Reactions (Hours After Removal of Dressing)
24 h 48 h
50% 25% 50% 25%
Er Oe Other Er Oe Other Er Oe Other Er Oe Other
1 0 0 - 0 0 - 0 0 - 0 0 -
2 0 0 - 0 0 - 0 0 - 0 0 -
3 0 0 - 0 0 - 0 0 - 0 0 -
4 0 0 - 0 0 - 0 0 - 0 0 -
5 0 0 - 0 0 - 0 0 - 0 0 -
6 0 0 - 0 0 - 0 0 - 0 0 -
7 0 0 - 0 0 - 0 0 - 0 0 -
8 0 0 - 0 0 - 0 0 - 0 0 -
9 0 0 - 0 0 - 0 0 - 0 0 -
10 0 0 - 0 0 - 0 0 - 0 0 -

Er=erythema

Oe=oedema

- = no other reactions noted

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk pharse is required.
Executive summary:

A study was performed to assess the contact sensitisation potencial of the test material in the albino guinea pig. Ten test and five control animals were used for the main study. Based on the results of sighting test, the concentration of the test material for the induction and challenge phases were selected as follows:

Intradermal Induction: 1% w/v in arachis oil BP

Topical Induction: undiluted as supplied

Topical Challenge: 50% and 25% v/v in arachis BP

The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk pharse is required.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Justification for non-LLNA method:
The tests were done before LLNA as first-choice method for in-vivo testing was set into force.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk pharse is required.
Executive summary:

The skin sensitisation potential of the target substance is estimated based on adequate and reliable in vivo studies of structural analogue source substances. The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No risk pharse is required. As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential .

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

Skin sensitisation

The skin sensitization potential of the whole range of alcohol ethoxylates (AEs) was evaluated by the majority in the guinea pig maximisation test according to the Magnusson Kligman and in the non-adjuvant Buehler test protocol in guinea pigs. In summary, all of the six studies conducted with the Cas-No. 71060-57-6, 68439-50-9, 68551-12-2, 66455-14-9, 68131-39-5 and 68439-49-6 showed that the AEs have no skin sensitizing potential. Hence, no classification is warranted. This is further supported by clinical data that demonstrate the absence skin sensitization responses to AE when tested under the conditions of the HRIPT (HERA, 2009).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 the substance does not need to be classified for skin sensitisation.

No data on respiratory sensitisation is available.