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Diss Factsheets

Administrative data

Description of key information

No study on sensitization is available for substance registered. Thus, read across is performed to the analogue substance sodium cocoyl glycinate (syn. Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine) for which a Magnusson & Kligman study is available. Based on structural similarities and the metabolism properties both chemicals are considered to be comparable in their toxicological profiles.


Read across justification for this approach is attached to section 13 of this IUCLID.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline-conform study under GLP without deviations
Justification for type of information:
Justification for Read across to analogue substance is attached (refer to Read across statement Section 13 of this IUCLID)
Reason / purpose for cross-reference:
read-across source
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
Principles of method if other than guideline:
name test item: SCG 3028 (sodium cocoyl glycinate)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In order to determine the dermal sensitisation potential of the test substance an in vivo M&K study according to OECD TG 406 was conducted. The Maximization test was selected since the test substance is a surfactant and the local Lymph Nose Assay as preferred alternative has shown to provide false positive results for surfactants.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 282 – 388 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 guinea pig breeding / maintenance diet, ad libidum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 2008-09-18 to 2008-10-13


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
MAIN STUDY
A: INDUCTION EXPOSURE (IN TEST GROUP)
-Intradermal induction:
Day 1: three intradermal injections/animal (0.1 mL/site)
- Freund's Complete Adjuvant/physiological saline, 1:1
- 5% test item in purified water
- 5% test item in a 1:1 mixture of Freund's Complete Adjuvant/physiological saline

Epidermal induction:
Day 7: application of 50% test item in purified water
Days 8 and 9: cutaneous reactions assessment
Day(s)/duration:
2
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
CHALLENGE EXPOSURE
Day 22: 0.2 mL of test item (5%) on 3 cm x 3 cm area on the left flank; 0.2 mL vehicle (purified water) on 3 cm x 3 cm area on the right flank
Day 23: dressing removal and skin reaction assessment
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 control animals (males)
10 treated animals (males)
Details on study design:
RANGE FINDING TESTS:
A: Intradermal injections:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved neck of one guinea pig)
Five days later: Four intradermal injections (0.1 mL/site) at concentrations of H = 15 %, I = 10 % and J = 5 % of the test item in purified water (clipped flank of the same guinea pig)
Dermal reactions assessed 24 hrs later.

B: Epidermal applications:
Four intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline (day 1) (shaved necks of two guinea pigs)
Five days later: Epidermal application with the test item at K = 15 %, L = 10 %, M = 5 % and N = 3 % in purified water (shaved flanks of the same two guinea pigs)
Dermal reactions assessed 24 and 48 hrs after removal of the bandage.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal / epicutaneously)
- Exposure period: injected / 48 h occlusive
- Site: scapular region (clipped free of hair)
- Frequency of applications: 1 / 1
- Duration: 0 - 8 days
- Concentrations:
1st application: 5% intradermal; 2nd application: 50% epicutaneous

B.
CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
-Exposure period: 24 hrs
- Site: left flank (test item); right flank: vehicle (clipped free of hair)
- Concentrations: 5% occlusive epicutaneous
- Evaluation (hr after challenge): 24 and 48 hrs
Positive control substance(s):
yes
Remarks:
ALPHA-HEXYLCINNAMALDEHYDE
Positive control results:
Discrete/patchy to moderate/confluent erythema with or without scaling was observed in nine out of ten test animals at the 24- and 48-hour reading after the challenge treatment with ALPHA-HEXYLCINNAMALDEHYDE at 1 % in PEG 300 (left shoulder). Five test animals showed discrete/patchy erythema at the 24-hour reading after treatment with ALPHAHEXYLCINNAMALDEHYDE at 0.1 % in PEG 300 (left flank). No skin effect was observed in the control group.
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, ALPHAHEXYLCINNAMALDEHYDE has to be classified and labelled as a skin sensitizer.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% in PEG 300 (left flank)
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
Five test animals showed discrete/patchy erythema
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1% in PEG 300 (left shoulder)
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Discrete/patchy to moderate/confluent erythema with or without scaling was observed in nine
out of ten test animals
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1% in PEG 300 (left shoulder)
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Discrete/patchy to moderate/confluent erythema with or without scaling was observed in nine
out of ten test animals
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% epicutane (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% epicutane (left flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0% epicutane, (right flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0% epicutane (right flank)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% epicutane (right flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Remarks:
control group with purified water
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0% epicutane (right flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% epicutane (left flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% epicutane (left flank)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no observations
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs and in accordance to Commission Directive 2001/59/EC, SCG 3028 does not have to be classified and labelled as a skin sensitizer.
Executive summary:

The sensitization potential of SCG 3028 was evaluated in guinea-pig according to the Maximization Test by Magnusson and Kligman.

The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5 % dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % one week after the intradermal induction

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 5 % in purified water under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

No toxic signs were evident in the guinea pigs of the control or test group. No deaths occurred. No skin reactions were observed in the control and test group after the challenge treatment with SCG 3028 at 5 % in purified water.

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

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 and based on the results of the OECD 406 study with the analogue substance, it is considered, that no classification is warranted for the registration substance Dodicor V5654 according to the OECD GHS criteria.