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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing – (GHS criteria not met)

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 performed in 2008.
LLNA method (OECD 442 B) was adopted in 2010.
Specific details on test material used for the study:
Test item:
Sponsor's identification: LCE07106
Container: plastic flask (n=1)
Quantity: 184.84 g (container + contents)
Batch n° 0715200018
Production data: 01 June 2007
Date received: 21 December 2007
Form: liquid
Colour: yellow
Storage: Room temperature
Re-test date: 31 May 2009
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (F-69592 L'Arbresle)
- Age at study initiation: 4 weeks old
- Weight at study initiation: between 232 and 283 g
- Housing: The animals 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.
- Food and drink: The drinking water (tap water from public distribution system) and food were supplied freely. Microbiological verification and chemical analysis were conducted every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B).
- Acclimation period: The animals were kept for a minimum acclimatisation period of 5 days, under stabling and nutritional conditions identical to those of the test.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 and 22 °C
- Humidity (%): between 45 and 70 %
- Lighting time:12 hours daily
Route:
intradermal and epicutaneous
Concentration / amount:
Day 0
After shearing the scapular zone, three pair of intradermal injections of 0.1 ml were 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 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 with equal volumes v/v
- Freund's Complete Adjuvant at 50% and the test item at 0.78%
Day 6
The scapular zone of all animals in each group was shorn.
Day 7
A topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal.
Group 2 (treated):
0.5 ml of the test item at 100%. After the removal of the patch, the treated areas were rinsed with distilled water.
Day(s)/duration:
The induction phase lasts 7 days
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
12.5 % (Maximal Non Irritant Concentration) and 6.25 % (1/2 MNIC)
Day(s)/duration:
the treatment lasts 24 hours for each concentration
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Negative control group: 5 animals
Treated group: 10 animals
Details on study design:
INDUCTION PHASE
Day 0
After shearing the scapular zone, three pair of intradermal injections of 0.1 ml were 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 Adujuvant diluted by 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 with equal volumes v/v
- Freund's Complete Adjuvant at 50% and the test item at 0.78%
Day 6
The scapular zone of all animals in each group was shorn.
Day 7
A topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal.
Group 1 (negative control):
0.5 ml of distilled water
Group 2 (treated):
0.5 ml of the test item at 100%. After the removal of the patch, the treated areas were rinsed with distilled water.

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 (treated) 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 12.5% (MNIC) and at 6.25 % (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
Positive control results:
Reference substance: alpha-Hexylcinnamaldehyde / CAS n° 101-86-0
Treated animals number: 10
In conclusion, in view of these results, under these experimental conditions, the substance alpha-Hexylcinnamaldehyde;
must be classified R 43 “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. This substance must be characterised by the symbol “Xi' and the warming label “Irritant”.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12.5 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No visible modification
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
9
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
9
Total no. in group:
10
Interpretation of results:
GHS criteria not met
Conclusions:
In view of these results, under these experimental conditions, the test item LCE07106 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 (COMC2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required.
Executive summary:

SUMMARY AND CONCLUSION OF THE STUDY

The aim of the study was to evaluate the possible allergenic activity of the test item LCE07106 after intradermic injection and topical administration in guinea pigs.

After induction (intradermic injection at 0.39% and topical application at 100%) of 10 Guinea Pigs of treated group with the test item LCE07106 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 12.5% and at 6.25% in distilled water. The experimental protocol was established according the O.E.C.D. guideline n°406 dated July 17", 1992 and the method B6 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 LCE07106 must not 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.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
Registered substance (as identified in Section 1.1 identification) has similar chemical structure as the others members of the Category "Amino Acid Alkyl Amides, Sodium or
Potassium Salts" (the source chemicals).

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” has been developed and evaluated to cover the assessment of the intrinsic properties of several similar
substances within the context of REACH Regulation. The Category includes sodium or potassium salts of amino acid alkyl amides, with a carbon chain length range of C6-C16 and an
aminoacidic pool of not selected aminoacids reflecting the natural distributions of aminoacids in various vegetables and cereals.


1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The Category has been built up considering the common chemical structure of its members. They are UVCB substances and they share the following features:
- they are salts of amino acid alkyl amides
- they are sodium or potassium salts
- the carbon chain length ranges between C6 and C16
- the carbon chain derives from cocoyl or lauroyl fatty acids
- the aminoacidic part of the molecules comes from a pool of aminoacids
- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Overall, the Category was formed on the hypothesis that substances sharing this common chemical structure can be considered analogues and can share intrinsic properties too. No
trends in properties is expected, except for those physicochemical properties depending on the carbon chain length.

2. CATEGORY APPROACH JUSTIFICATION
These substances share (i) eye damage and (ii) the absence of significant systemic toxicity.
Key result
Reading:
other: read-across approach
Group:
positive control
Remarks on result:
other: Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
Remarks:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
Key result
Reading:
other: read-across approach
Group:
negative control
Remarks on result:
other: Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
Remarks:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
Key result
Reading:
other: read-across approach
Group:
test chemical
Remarks on result:
other: Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
Remarks:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
Interpretation of results:
GHS criteria not met
Conclusions:
A collection of the skin sensitisation data is available for category members.
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing – (GHS criteria not met); considering these values the registered substance is not sensitizer.

According to Regulation (EC) n. 1272/2008, the registered substance should not be classified for the skin sensitization data are judged as "conclusive but not sufficient for classification".
Executive summary:

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” was formed on the hypothesis that substances sharing common chemical structure can be considered analogues and can share intrinsic properties too.

Based on this assumption, this property may be assessed using available data  for the category members.

The category has been assessed for members characterized by:

- sodium or potassium salts

- the carbon chain length ranges between C6 and C16

- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

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
Justification for type of information:
No in vitro test was proposed because this guinea pig test was done in 2004 and no in vitro test existed at that time (OECD tests n°442 C and D adopted in 2015)
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:
No in vitro test was proposed because this guinea pig test was done in 2004 and no in vitro test existed at that time (OECD tests n°442 C and D adopted in 2015)
Specific details on test material used for the study:
The product LCE03072, sent by SEPPIC – Avenue Lacaze Basse –F-81105 CASTRES, was received
on 22 December 2003. Its characteristics were :
· Container : plass flask
· Form : liquid
· Quantity : 154.84 g (container + contents)
· Colour : colorless
· Batch : -
· Storage : room temperature
· CAS N° : -
· Purity : -
It was identified under the code number: PH-03/0428.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
15 male albino guinea pigs of Dunkin-Hartley strain, supplied by Centre de Production animale (F- 45160 Olivet) were exposed to the test product after a 6-day acclimatisation period. For the main study, the animals weighted between 246g and 350g at the beginning of the test.

The environmental parameters were :
- Temperature : between 19°C and 26°C
- Relative humidity : between 30% and 66%
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Induction phase
1st induction
- 2 intradermal injections of the product diluted at 12.5% in physiological saline solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in physiological
saline solution
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%.

Challenge phase : topical application under occlusive dressing at the following concentrations : 50% & 25%.
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Induction phase
1st induction
- 2 intradermal injections of the product diluted at 12.5% in physiological saline solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in physiological
saline solution
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%.

Challenge phase : topical application under occlusive dressing at the following concentrations : 50% & 25%.
No. of animals per dose:
GROUP 1 (negative control) : 5 female guinea pigs identified n° C9296 to C9300;
GROUP 2 (treated) : 10 female guinea pigs identified n° C9311 to C9320.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
7
Total no. in group:
10
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In view of these results, under these experimental conditions, the product LCE03072, 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.
Executive summary:

After induction (intradermic injection and topical application) of 10 Guinea Pigs (female) of treated group with the test product LCE03072 and a 18-days rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product diluted at 50% and at 25% in distilled water, 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.

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 LCE03072, 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)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A collection of the skin sensitisation data is available for category members. All found values are listed below.

EC number

Skin sensitisation

S1 - EC: 918-984-3

not sensitizing - GHS criteria not met

S2 - EC: 927-837-2

not sensitizing - GHS criteria not met

 

Overall, registered substance is not sensitizer.

According to Regulation (EC) n. 1272/2008, the substance should not be classified for the skin sensitization data are judged as "conclusive but not sufficient for classification".

According to Regulation (EC) n. 1272/2008, the substance should not be classified for the respiratory sensitization because of data lacking.