Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1)

Endpoint summary

Description of key information

An assessment on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) following exposure via the oral route was undertaken based on available data on the individual constituents of the substance. It concluded that is not necessary to conduct a new study on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1), because substantial repeated dose toxicity data is already available in the literature for the constituents of the reaction mass and the repeated-dose toxicity of the substance is expected to be driven by its individual constituents.

Using the most conservative approach, the lowest value across the two constituent substances of the reaction mass has been taken. This approach is considered to be conservative. Therefore, it can be concluded that the short-term repeated dose toxicity value for Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is NOAEL = 140 mg/kg bw.

In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. No significant exposure to Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is expected taking into account the uses of the substance. Therefore no exposure of humans via the dermal and inhalation routes is expected.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

other: An assessment was undertaken based on available data on the individual constituents of the substance

Adequacy of study:

key study

Study period:

May 15, 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was undertaken based on available data on the individual constituents of the substance

Qualifier:

no guideline followed

Principles of method if other than guideline:

An assessment was undertaken based on available data on the individual constituents of the substance

GLP compliance:

no

Gross pathological findings:

effects observed, treatment-related

Key result

Dose descriptor:

NOAEL

Effect level:

140 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

body weight and weight gain

urinalysis

Critical effects observed:

not specified

Conclusions:

An assessment was undertaken based on available data on the individual constituents of the substance. It is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) has a NOAEL = 140 mg/kg bw/d and

Executive summary:

An assessment on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) following exposure via the oral route was undertaken based on available data on the individual constituents of the substance. It concluded that is not necessary to conduct a new study on the short-term repeated dose toxicity of Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1), because substantial repeated dose toxicity data is already available in the literature for the constituents of the reaction mass and the repeated-dose toxicity of the substance is expected to be driven by its individual constituents.

Using the most conservative approach, the lowest value across the two constituent substances of the reaction mass has been taken. This approach is considered to be conservative. Therefore, it can be concluded that the short-term repeated dose toxicity value for Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) is NOAEL = 140 mg/kg bw.

Based on the classification of the constituents of the registered substance, it is concluded that it will not trigger the specific target organ toxicity (STOT) classification in accordance with Regulation (EC) N° 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

140 mg/kg bw/day

Study duration:

subacute

Species:

other: Data obtained on several species were considered as part of the assessment of the repeated-dose toxicity of the registered substance

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant dermal contact is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH, Annex XI, no testing is required as no significant dermal contact is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the classification of the constituents of the registered substance, it is concluded that Reaction mass of morpholine and 6-[(p-tosyl)amino]hexanoic acid, compound with morpholine (1:1) will not trigger the specific target organ toxicity (STOT) classification in accordance with Regulation (EC) N° 1272/2008.