Registration Dossier

Administrative data

Description of key information

The substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine is considered being sensitising to skin, based on read-across to a similar substance.

Data for respiratory sensitisation are not available and no case of respiratory sensitisation is known. Considering the low vapour pressure of the substance however, respiratory exposure, resulting in respiratory sensitisation is very unlikely.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
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 target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylene-tetramine (TOFA-MA-TETA) and the source substance Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA) are characterised by the same starting materials: the hydrophobic part from fatty acids and the hydrophilic part from the polyethyleneamines.
The source substance is a mixture of ethyleneamines of different lengths (DETA, TETA and TEPA). The target substance contains only one ethyleneamine: TETA.
The source and the target substance show therefore the same reactive groups and a similar composition with the absence of two original ethyleneamines (DETA and TEPA) as biggest difference. A read-across to the source is therefore justified.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance actually is manufactured from the same starting materials of the source:
Fatty acids, tall-oil and maleic anhydride. TOFA is reacted with maleic anhydride to make a Diels-Alder intermediate which is a tri-acid. This is reacted with the TETA to produce a mixture of amido-amine & oligomeric UVCB constituents. The source substance also contains two other ethyleneamines: di-ethylenetriamine and tetraethylenepentamine.
The source substance has been registered already and was found being sensitiser. The absence of two amines does not influence the sensitisation effect of the substance.

3. ANALOGUE APPROACH JUSTIFICATION
The target substance is one of the constituent of the UVCB source substance and thus read-across from the bigger compound Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine to TOFA-MA-TETA is common practice and justified.

4. DATA MATRIX
Whereas the source substance is a Fatty acids, tall-oil, reaction products with di-ethylenetriamine (DETA), maleic anhydride, tetraethylenepentamine (TEPA) and triethylenetetramine (TETA), hence using a mixture of DETA, TETA and TEPA as reactant, the target substance uses pure TETA (triethylenetetramine) instead, being a more purified (narrower cut distillation) form of DETA/TETA/TEPA resulting in a name change of the target substance, being Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine (TETA).
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Reading:
other: Intradermal Induction I, Injection site 1
Hours after challenge:
24
Group:
test group
Dose level:
0%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 1
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 2
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 2
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 3
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
3
Total no. in group:
5
Clinical observations:
erythema grade 1
Reading:
other: Intradermal Induction I, Injection site 3
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 1
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 1
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 1
Hours after challenge:
48
Group:
test group
Dose level:
0%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema grade 1, oedema grade 1, eschar
Reading:
other: Intradermal Induction I, Injection site 1
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
eschar
Reading:
other: Intradermal Induction I, Injection site 2
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 2
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 3
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
erythema grade 1, oedema grade 1
Reading:
other: Intradermal Induction I, Injection site 3
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
erythema grade 1, oedema grade1
Reading:
other: dermal induction
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
eschar
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Under the conditions of the study on the read-across substance Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine it can be stated that the target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine is also considered being sensitising to skin.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Under the conditions of a study on the read-across substance Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine it can be stated that the target substance Fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine is also considered being sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Data for respiratory sensitisation are not available and no case of respiratory sensitisation is known. Considering the low vapour pressure of the substance however, respiratory exposure, resulting in respiratory sensitisation is very unlikely.

Justification for classification or non-classification

Based on in vivo test data with a very similar substance, the substance fatty acids, tall-oil, reaction products with maleic anhydride and triethylenetetramine is considered being sensitising to skin and thus is to be classified as skin sensitiser, category 1 (H317) according to CLP (Regulation EC No 1272/2008).