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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-02 to 2008-07-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 2008.
LLNA method (OECD 442 B) was adopted in 2010.

Test material

Constituent 1
Reference substance name:
Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts
EC Number:
500-500-3
EC Name:
Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts
Cas Number:
161074-67-5
Molecular formula:
Not applicable
IUPAC Name:
Acylation product between lauroyl chloride and amino acids
Test material form:
liquid
Details on test material:
• Sponsor’s identification: LCE08088
• Container : plastic flask (n=1)
• Quantity : 1056.60 g (container + contents)
• Batchn° :0801000014
• Production date: 10 January 2008
• CASNo:It was identified under the code number: Pif-08/0226.
• Date reeeived : 22 May 2008
• Form: liquid
• Colour : yellow
• Storage : room temperature
• Retest date: 09 January 2011
• Purity: 28,7% dry extract
Specific details on test material used for the study:
Test item
Sponsor's identification: LCE08088
Container: plastic flask (n=1)
Quantity: 1056,60 g (container + contents)
Batch: 0801000014
Form: liquid
Colour: yellow
Storage: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Housing
The animais were housed either in groups of 2 or 3 in polycarbonate containers, the flooring of which was covered with dust-free cuttings and the top fitted a stainless steel lid with a feeding device and drinking device of 500 ml.
The enviromnental parameters of the main test were:
- Temperature: between 19°C and 24°C
- Relative humidity : between 40% and 70%
- Lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour

Food and drink
The drinking water (tap water from public distribution system) and food were supplied freely.
Microbiologicai verification and chemicai analysis were conducted every six months by the Institut Européen de l’Environnement de Bordeaux (I.E.E.B.).

Preparation of animals
For the main study, 16 female albino guinea pigs of Dunkin-Hartley strain, supplied by Charles River (F-69592 L’Arbresle) weighed between 250 g and 283 g at the beginning of the test and were 4 to 5 weeks old,
Prior to the test, the animals were kept for a minimum acclimatisation period of 5 days, under stabling and nutritional conditions identical to those of the test.
Before the experimentation process, they were identified individually by marking with picric acid and a tattoo placed on their ear.
The animais were carefully shorn before each test item application:
- on the inter-scapular zone for the induction phase,
- on the dorso-lumbar zone for the challenge phase.
At least 3 hours before the first reading (challenge phase) they were shorn a second time in the dorsolumbar zone.
The animals were weighed at the beginning and at the end of the study.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Concentration / amount:
Induction phase
1st Intradermal Induction:
Day 0
Alter shearing the scapular zone, three (3) pairs of intradermal injections ([D) of 0.1 ml vere performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follows:
GROUP 1 (Negative control):
• 2 ID: Freund’s Complete Adjuvant diluted at 50 % in isotonic sodium chloride.
• 2 ID: isotonic sodium chloride
• 2 ID: a mixture with equal volumes v/v:
- Freund’s Complete Adjuvant at 50% and isotonic sodium chloride,
GROUP 2 (Treated):
• 2 ID: Freund’s Complete Adjuvant diluted by 50 % in isotonic sodium chloride,
• 2 ID: test item at 0.39%,
• 2 ID a test mixture in equal volumes v/v:
- Freund’s Complete Adjuvant at 50% and the test item at 0.78%.
2nd Topical Induction:
Day 6
The scapular zone of ail the animais in each group was shorn beforehand.
Day 7
A topical application under occlusive dressing for 48 hours vas performed on the injection sites of each animal.
GROUP I Negative control): 0.5 ml of distilled water
GROUP 2 (treated): 0.5 ml of the test item at 100%
Day(s)/duration:
7 days
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Concentration / amount:
Challenge phase
Day 20
The experimental procedure of this phase was identical for both groups GROUP 1 (Negative control) and GROUP 2 (Treatecl) submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, was performed during 24 hours:
- 1 sample cup containing the test item at 3.125% (MNIC) and at 1.56% (1/2 MNIC).
Day(s)/duration:
24 hours for each concentration
No. of animals per dose:
GROUP 1 (negative contol) : 5 female guinea pigs idcntified n° C0352 to C0356
GROUP 2 (treated) : 11 female guinea pigs identified n° C0357 to C0367
Details on study design:
Induction phase
1st Intradermal Induction:
Day 0
Alter shearing the scapular zone, three (3) pairs of intradermal injections ([D) of 0.1 ml vere performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follows:
GROUP 1 (Negative control):
• 2 ID: Freund’s Complete Adjuvant diluted at 50 % in isotonic sodium chloride.
• 2 ID: isotonic sodium chloride
• 2 ID: a mixture with equal volumes v/v:
- Freund’s Complete Adjuvant at 50% and isotonic sodium chloride,
GROUP 2 (Treated):
• 2 ID: Freund’s Complete Adjuvant diluted by 50 % in isotonic sodium chloride,
• 2 ID: test item at 0.39%,
• 2 ID a test mixture in equal volumes v/v:
- Freund’s Complete Adjuvant at 50% and the test item at 0.78%.
2nd Topical Induction:
Day 6
The scapular zone of ail the animais in each group was shorn beforehand.
Day 7
A topical application under occlusive dressing for 48 hours vas performed on the injection sites of each animal.
GROUP I Negative control): 0.5 ml of distilled water
GROUP 2 (treated): 0.5 ml of the test item at 100%
Rest phase
The animals of both groups were left for 10 days.

Challenge phase
Day 20
The experimental procedure of this phase was identical for both groups GROUP 1 (Negative control) and GROUP 2 (Treatecl) submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, was performed during 24 hours:
- 1 sample cup containing the test item at 3.125% (MNIC) and at 1.56% (1/2 MNIC).
Challenge controls:
The Group 1 (negative control) was submitted to the same experimentation as Group 2 (treated group) during the challenge phase.
Positive control substance(s):
yes
Remarks:
alpha-Hexylcinnamaldehyde

Results and discussion

Positive control results:
Positive control was performed on:
- 12 February 2008
- 16 October 2007
- 16 january 2007
In view of the obtained results, under the applied experimental conditions, the substance alpha-Hexylcinnamaldehyde must be classified R43 "may cause sensitization by skin contact" in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3.125%
No. with + reactions:
0
Total no. in group:
11
Clinical observations:
Erythema, oedema: none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3.125%. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: Erythema, oedema: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3.125%
No. with + reactions:
0
Total no. in group:
11
Clinical observations:
Erythema, oedema: none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3.125%. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: Erythema, oedema: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1.56%
No. with + reactions:
0
Total no. in group:
11
Clinical observations:
Erythema, oedema: none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.56%. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: Erythema, oedema: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.56%
No. with + reactions:
0
Total no. in group:
11
Clinical observations:
Erythema, oedema: none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.56%. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: Erythema, oedema: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3.125%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3.125
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1.56
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1.56
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
7
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, in view of these results, under these experimental conditions, the test item LCE08088 must not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classifïed in category 1. No signal word and hazard statement are required.
Executive summary:

The aim of the study vas to evaluate the possible allergenic activity of the test item LCE08088 after intradermic injection and topical administration in guinea pigs.

After induction (intradermal injection at 0.39% and topical application at 100%) of 11 Guinea Pigs of treated group with the test item LCE08088 and a 10-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test item diluted at 3.125% and at 1.56% in distilled water, The experimental protocol was established according the OECD guideline n 406 dated July 17th, 1992 and the method B. 6 of the E. E. C, n°96/54 dated July 30th 1996.

No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.

No cutaneous intolerance reaction was recorded in animals from the negative control group.

In conclusion, in view of these results, under these experimental conditions, the test item LCE08088 must not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required.