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Administrative data

Description of key information

According to Guideline OECD Guideline 406 (Skin Sensitisation):

Assessment of sensitising properties on albino guinea pig Maximisation was performed.

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
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 performed in 2004. LLNA method (OECD 442 B) was adopted in 2010 and also the (OECD tests n°442 C , D) was adopted in 2015
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
32 albino guinea pigs of Dunkin-Hartley strain, supplied by Centre de Production animale (F-45160
Olivet) were exposed to the test product after a 5-day acclimatisation period. For the main study, the
animals weighted between 219g and 399g at the beginning of the test.
Route:
intradermal and epicutaneous
Vehicle:
olive oil
Concentration / amount:
1st induction
- 2 intradermal injections of the product diluted at 1.562% in olive oil.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a
physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 3.125% in olive oil.
2nd induction: topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.

1st Challenge phase : topical application under occlusive dressing at the
following concentrations : 6.25% & 3.125%.
2nd challenge phase : topical application under occlusive dressing at the
following concentrations : 3.125% and 1.56%
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
1st induction
- 2 intradermal injections of the product diluted at 1.562% in olive oil.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a
physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 3.125% in olive oil.
2nd induction: topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.

1st Challenge phase : topical application under occlusive dressing at the
following concentrations : 6.25% & 3.125%.
2nd challenge phase : topical application under occlusive dressing at the
following concentrations : 3.125% and 1.56%
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Main study 1st test
Induction phase
1st induction
- 2 intradermal injections of the product diluted at 1.562% in olive oil.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a
physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 3.125% in olive oil.
Weighing of animals.

2nd induction: topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.

Rest phase: 17 days

1st Challenge phase : topical application under occlusive dressing at the
following concentrations : 6.25% & 3.125%.
24-hours reading time.
48-hours reading time and weighing.

Rest phase: 6 days

2nd challenge phase : topical application under occlusive dressing at the
following concentrations : 3.125% and 1.56%
24-hours reading time.
48-hours reading time and weighing.


Main study – 2nd test
Induction phase
1st induction
- 2 intradermal injections of the product diluted at 1.562% in olive oil.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a
physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s
Complete Adjuvant at 50% and the product diluted at 3.125% in olive oil.
Weighing of animals.
2nd induction: topical application, on the same zone, with the product at
100%, 24 hours after brushing with 0.5 ml of a solution of Sodium lauryl
sulfate at 10%.
Rest phase: 18 days
Challenge phase : topical application under occlusive dressing at the
following concentrations : 3.125% & 1.56%.
24-hours reading time.
48-hours reading time and weighing.
Positive control substance(s):
yes
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3 %
No. with + reactions:
2
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 2.0. Total no. in groups: 11.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1.56
No. with + reactions:
0
Total no. in group:
11
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.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.56
No. with + reactions:
0
Total no. in group:
11
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.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3 %
No. with + reactions:
1
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3 %. No with. + reactions: 1.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3 %
No. with + reactions:
1
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3 %. No with. + reactions: 1.0. Total no. in groups: 5.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3 %
No. with + reactions:
4
Total no. in group:
21
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 4.0. Total no. in groups: 21.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3 %
No. with + reactions:
2
Total no. in group:
21
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 2.0. Total no. in groups: 21.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
3
Total no. in group:
21
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 3.0. Total no. in groups: 21.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
21
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 21.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 11.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
12%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
12%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
other: not classified
Conclusions:
In conclusion, in view of these results, under these experimental conditions, the product LCE03043, in
accordance with the criteria for classification, packaging and labelling of dangerous substances of the
E.E.C. Directives 67/548, 2001/59 and 99/45, must not be classified.
Executive summary:

After induction (intradermic injection and topical application) of 10 Guinea Pigs of treated group with the test product LCE03043 and a 17-days rest phase, the 1st challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product diluted at 6.25% and 3.125% in paraffin oil, according to the experimental protocol established from the O.E.C.D. guideline n°406 dated July 17th, 1992 and the method B.6 of the E.E.C. n°96/54 dated July 30th, 1996.

It was noted a macroscopic cutaneous reaction (moderate erythema) 24 hours following the removal of the occlusive dressing, in 44% (4/9) of treated animals, on the area treated at 6.25% and 3.125%, and in 25% (1/4) of control animals, on the area treated at 6.25% and 3.125%, and in 25% (1/4) of control animals on the area treated at 6.25% and 3.125%. These reactions were ever recorded at the reading 48 hours, respectively in 22% (2/9) and 11% (1/9) of treated animals, on the area treated at 6.25% and 3.125% and in 25% (1/4) of control animals on the area treated at 6.25% and 3.125%.

In view to confirm or infirm this reaction, a second challenge phase has been carried out, with the test product diluted at 3.125% and 1.56% in paraffin oil, after a 6-days rest phase.

It was noted a moderate erythema, 24 hours following the removal of the occlusive dressing, in respectively 44% (4/9) and 33% (3/9) of treated animals, on the area treated at 3.125% and 1.56%. These reactions were ever recorded at the reading 48 hours in 22% (2/9) of treated animals, on the area treated at 3.125%.

Taking into account the doubtful of these reactions, the test has been completed with 5 control animals and 10 treated animals in accordance with the experimental protocol.

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 product.

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 product LCE03043, 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, must not be classified.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

According to Guideline OECD Guideline 406 (Skin Sensitisation)


Assessment of sensitising properties on albino guinea pig Maximisation was performed.


 


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 product.


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, in accordance with the criteria of the Regulation (EC) No. 1272/2008, must not be classified.