Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1997

Materials and methods

Test guidelineopen allclose all
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.

Test material

Constituent 1
Reference substance name:
Alcohols, C12-14, ethoxylated
EC Number:
500-213-3
EC Name:
Alcohols, C12-14, ethoxylated
Cas Number:
68439-50-9

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Intradermal Induction: 1% w/v in arachis oil BP
Topical Induction: undiluted as supplied
Challenge
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.