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Diss Factsheets

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:
July-September 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No info on batch no. and composition. Well reported and conducted study according to guideline/standards.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis is based on “different compounds which have similar properties”.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- The source substance is identified as Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, also known as Sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate (CAS no. 94441-92-6 | EC no. 305-318-6). It is a UVCB substance whose major constituent is sodium 2-ethylhexylimino-di-propionate. Minor constituents are sodium 2-ethylhexylimino-mono-propionate, unreacted acrylic acid and unreacted 2-ethylhexylamine.
- The target substance is identified as Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide (methanol free) (CAS no. 68610-44-6| EC no. 271-865-1). It is a UVCB substance whose major constituents are sodium 2-ethylhexylimino-mono-propionate and sodium 2-ethylhexylimino-di-propionate. Minor constituents are unreacted acrylic acid and unreacted 2-ethylhexylamine.

3. ANALOGUE APPROACH JUSTIFICATION
The target and source substances are essentially the same: both are UVCB substances composed of the exact same constituents with the exact same functional groups (i.e. carboxylic acid groups and secondary/tertiary amine groups). They are expected to have the same ADME profile and to share common mode of action and breakdown products. The target and source substances only differ in the overlapping ranges of their constituents, the content of sodium 2-ethylhexylimino-mono-propionate being especially higher in the target substance. This difference is expected to have no or very limited impact on the potency of effects exerted on exposed living organisms.

4. DATA MATRIX
Cf. read-across justification document attached in §13. Assessment reports.
Reason / purpose for cross-reference:
read-across: supporting information
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 and 100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
No positive control group in the study
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 and 100 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
No posiitve control group in the study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

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
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
An alternative adequate study was already available. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 671548/EEC).

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
EC Number:
305-318-6
EC Name:
Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
Cas Number:
94441-92-6
Molecular formula:
C14H26NO4.Na
IUPAC Name:
sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate
Test material form:
liquid
Details on test material:
Date of receipt: 25 June and 28 August 1997
Appearance: clear yellow liquid
Storage: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Ltd., Burton-on-Trent, UK
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: 300-392 g
- Housing: singly or in pairs in polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 54-78
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From:30 July To: 3 September 1997

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
100% (undiluted)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75% (v/v) in distilled water
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
100%
No. of animals per dose:
20 test and 10 control animals
Details on study design:
RANGE FINDING TESTS:
Induction (2 guinea pigs): 25, 50, 75 (v/v) and 100&% (undiluted); 100% was selected
Challenge: not done due to a lack of test material; 100% and 75% (v/v) were selected.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: days 0, 2, 4, 7, 9, 11, 14, 16 and 18
- Test groups: yes
- Control group: no (blank patch)
- Site: left flank
- Frequency of applications: 9 times
- Duration: 6 h each time
- Concentrations: 100% (undiluted)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 h
- Test groups: yes
- Control group: yes
- Site: right flank
- Concentrations: 100% (undiluted) and 75% (v/v)
- Evaluation (hr after challenge): 24 and 48 h after patch removal

Challenge controls:
Yes, silimar to test group
Positive control substance(s):
no

Results and discussion

Positive control results:
Not used.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
No positive control group in the stuyd
Total no. in group:
0
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 and 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 and 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Results not specified in the report / Considered validated by the data Owner and the Testing Facility / Therefore considered without reaction
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
No positive control group in the study
Total no. in group:
0
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, Ampholak YJH-40 is not a sensitiser to guinea pig skin.
Executive summary:

A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 671548/EEC). Twenty test and ten control animals were used for the main study.

Based on the results of a sighting test, the concentration of test material for the induction phase was selected as follows:

Topical Induction: undiluted as supplied;

Based on the results of the induction phases of the study the concentrations of test material for the challenge phase were as follows:

Topical Challenge : undiluted as supplied and 75% v/v in distilled water.

The test material produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to OECD/GHS.