Registration Dossier

Administrative data

Description of key information

The test article fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine was assessed for dermal corrosion/irritation in an in vivo OECD 404 study and for eye damage/irritation in an in vivo OECD 405 study, both performed with three New Zealand White rabbits. In both studies, only slight irritation was observed and following the scoring system interpretation in GHS, the substance is neither irritant to skin or eyes. The target substance, fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine is sufficiently similar to conclude that these findings can also be used for the target substance, accordingly. No study for respiratory irritation is available and respiratory irritation is unlikely at ambient temperature, considering the low vapour pressure of the substance.

However, based on incidence reports from workers in production facilities about irritation of skin eyes and respiratory system, where workers are exposed to the molten substance (~100 °C when drumming of), in a precautionary approach, the substance is classified as skin and eye irritant, category 2 (H315 and H319) and as respiratory irritant (STOT SE 3, H335).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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 NON IRRITANT for the skin. The absence of two amines does not influence the irritation 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
Reason / purpose:
exposure-related information
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test article fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine , a suitable surrogate for fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine, when administered to rabbits by dermal route, is to be considered non-irritant for the skin. However, based on incidence reports from workers in production facilities, in a precautionary approach, the substance is classified as skin and eye irritant, category 2 (H315 and H319) and as respiratory irritant (STOT SE 3, H335).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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 not irritant for the eye. The absence of two amines does not influence the irritation 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
Reason / purpose:
exposure-related information
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test article fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine, a suitable surrogate for fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine, administered to rabbits as a single ocular application, is to be considered ”non-irritant” for the rabbit eye. However, based on incidence reports from workers in production facilities, in a precautionary approach, the substance is classified as skin and eye irritant, category 2 (H315 and H319) and as respiratory irritant (STOT SE 3, H335).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

In in vivo studies the substance was found neither irritating to skin or to eyes. As a result, classification for skin and eye irritation according to CLP (Regulation EC No 1272/2008) is not required. Data for respiratory irritation are not available, but considering the low vapour pressure, respiratory exposure, resulting in irritation (STOT SE 3) is considered unlikely. However, based on incidence reports from workers in production facilities in which the substance is handled as hot melt, in a precautionary approach, the substance is classified as skin and eye irritant, category 2 (H315 and H319) and as respiratory irritant (STOT SE 3, H335) according to CLP (Regulation EC No 1272/2008).