Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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)
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reason / purpose for cross-reference:
assessment report
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitization property of the registration substance (Reaction products of DL-methionine and C18 unsaturated fatty acid cholride and isopropanol) is derived based on the read across to "Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine". No skin sensitizing property can be reliabily derived.
Executive summary:

The skin sensitization property of the registration substance (Reaction products of DL-methionine and C18 unsaturated fatty acid cholride and isopropanol) is derived based on the read across to "Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine".

Due to structural chemical similarities and the metabolic considerations, the skin sensitization property of the target chemical is likely to be comparable to the source chemicals. No skin sensitizing property can be reliabily derived.

Data source

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

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
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.

Test material

Constituent 1
Reference substance name:
Sodium cocoyl glycinate (SCG) [INCI]
IUPAC Name:
Sodium cocoyl glycinate (SCG) [INCI]
Details on test material:
- Physical state: liquid
- Stability under test conditions: stable at room temperature
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected.

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
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
Challenge
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

Results and discussion

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.

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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.