Tall oil, reaction products with diethylenetriamine

Endpoint summary

Description of key information

No data are provided for the submission substance and none are required based on its classification as a skin corrosive. Read-across data are available for the major components (AAI_DETA and Rosin) of DTO_DETA.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

It is considered appropriate to address the data requirements for DTO_DETA by read-across to the available studies on the main components of DTO_DETA: AAI_DETA and Rosin.
DTO_DETA contains comparatively lower levels of imidazolines and higher levels of resin acids than AAI_DETA and therefore consideration of data for resin acids is also considered necessary. The main resin acid in DTO_DETA is abietic acid, but abietic acid derivatives and other acids, such as pimaric acid, are also found in notable quantities, and the resin acids collectively are known as ‘rosin’. DTO_DETA contains up to 25% unreacted rosin, and taking into account the compositional information available for the rosin in DTO_DETA and Rosin (CAS# 8050-09-07, EC# 232-475-7), the latter was considered appropriate for read-across to DTO_DETA.
An LLNA (OECD 429) is available for AAI_DETA (CIT, 2007), the main component in DTO_DETA. Based on the results of this study, AAI_DETA was classified as a Category 1A Skin Sensitiser. A guideline guinea pig maximisation test (NOTOX, 2010) is also available with the read across substance AAI_DETA; this study confirms the result obtained in the LLNA. As AAI_DETA is a major component in DTO_DETA, read across to the AAI_DETA dataset is justified and presents the worst case approach. Several negative studies (LLNAs, guinea pig maximisation tests and a Buehler assay) conducted with Rosins are provided as supporting information; these studies are provided to demonstrate that the Rosin component of DTO_DETA will not significantly increase the hazard profile of DTO_DETA with respect to skin sensitisation. A positive study conducted with Wood Rosin (CTL, 1997g) is available and is included in the dossier for information purposes, however the study was disregarded because the test substance sample was heavily oxidised and degraded.

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

EC3

Value:

0.3

Parameter:

SI

Value:

1

Test group / Remarks:

0.05% test item

Parameter:

SI

Value:

1.88

Test group / Remarks:

0.1% test item

Parameter:

SI

Value:

1.67

Test group / Remarks:

0.25% test item

Parameter:

SI

Value:

5.91

Test group / Remarks:

0.5% test item

Parameter:

SI

Value:

18.65

Test group / Remarks:

1% test item

Interpretation of results:

Category 1A (indication of significant skin sensitising potential) based on GHS criteria

Conclusions:

Based on the results of the read across study, DTO_DETA is considered to be skin sensitiser. Classification according to CLP is required (Cat 1A Skin Sensitiser).

Executive summary:

A guideline (OECD 429) LLNA (CIT, 2007) is available for the read across (source) substance, AAI_DETA. Read across from AAI_DETA to the target, DTO_DETA, is considered appropriate because AAI_DETA is a major component of DTO_DETA. AAI_DETA was found to be to a strong skin sensitiser. Therefore, based on the results of this study, DTO_DETA should be classified as a Category 1A Skin Sensitiser according to the CLP Regulation. Several studies (LLNAs, guinea pig maximisation tests and a Buehler assay) are available for the Rosin data set, and are presented as supporting read across information to demonstrate that the Rosin component of DTO_DETA will not significantly increase the hazard profile of DTO_DETA with respect to skin sensitisation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

No data are provided for the submission substance and none are required based on its classification as a skin corrosive. However read-across data are available for the major components (AAI_DETA and Rosin) of DTO_DETA and these are taken into account. Based on a weight of evidence, rosins are not considered to be skin sensitisers.

An LLNA study conducted with AAI_DETA (a major component of DTO_DETA) shows a positive response, DTO_DETA is therefore also considered likely to be a skin sensitiser.

Respiratory sensitisation

Link to relevant study records

Reference

Endpoint:

respiratory sensitisation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No studies investigating respiratory sensitisation are available and none are required; inhalation exposure is considered highly unlikely based on the physico-chemical properties of one of the major components of DTO_DETA, and as DTO_DETA is classified as corrosive further testing is not justified on animal welfare grounds.

Justification for classification or non-classification

Based on read across to an LLNA study conducted with AAI_DETA (a major component of DTO_DETA), DTO_DETA should be classified as a Category 1A Skin Sensitiser according to the CLP Regulation.