Tall oil, reaction products with diethylenetriamine

Endpoint summary

Description of key information

No data are provided for the submission substance. Endpoints are addressed by read across to available data for the major components of the submission substance (AAI_DETA and Rosin). Based on read across to data obtained with AAI_DETA, DTO_DETA is considered to be corrosive.

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:

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.
In vitro and in vivo studies conducted on Rosins indicate that these substances are not skin irritants. However AAI_DETA was found to be corrosive to rabbit skin in an in vivo guideline study (CIT, 2008). As the AAI_DETA dataset is clearly worst case with respect to skin irritation/corrosion, and therefore read across to AAI_DETA is considered appropriate for the target substance, DTO_DETA.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

4-hour exposure

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

14 days

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

4-hour exposure

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Severe burn observed on Day 2; animal sacrificed for ethical reasons

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Severe burn observed on Day 2; animal sacrificed for ethical reasons

First animal: 3-min: moderate to severe erythema up to day 8 and very slight erythema still at day 15. Slight oedema was visible from day 2 until day 8, and was completely resolved by day 10. 1-hour: moderate to severe erythema up to day 11 and very slight erythema still at day 15. Slight oedema was visible from day 2 until day 13, and was completely resolved on day 14. 4-hours: moderate to severe erythema up to day 13 and very slight erythema still at day 15. Slight oedema was visible from day 2 until day 13, and was completely resolved on day 14. With all exposure durations, a brownish area at the application site was noted from day 2 until day 10. Crusts and dryness of the skin were noted between day 5 and day 15 (end of the observation period). Second animal: 4-hours: a moderate then a severe erythema (grade 3 then 4) was noted on days 1 and 2, respectively. A severe edema (grade 4) was noted on days 1 and 2. A red-brown area was noted on day 2. Cutaneous reactions observed in the second animal were similar to a severe burn, and animal was sacrificed.

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Based on the results of the read across study, DTO_DETA is considered to be corrosive to rabbit skin following a 4-hour application. Classification according to CLP is required (Cat 1C, corrosive).

Executive summary:

A guideline (OECD 404) in vivo skin irritation study (CIT, 2008) 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 corrosive to rabbit skin following a four hour exposure period, and classification in Category 1C for skin corrosion was assigned according to CLP. 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No data are available for the target substance, DTO_DETA. Read across to skin irritation studies conducted on the major components of DTO_DETA is considered appropriate and sufficient for classification. No information is available for respiratory irritation.

Justification for classification or non-classification

Based on read across to data available for AAI_DETA (a major component of DTO_DETA), DTO_DETA should be classified as Skin Corrosive Category 1C 'Causes severe skin burns and eye damage' according to CLP. No classification is proposed for respiratory irritation, in the absence of relevant data.