2-Methyloctane-1,8-diamine

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)

Conclusions:

It is considered that performing irritancy studies via the dermal or ocular routes are unlikely to yield any additional data to those already available. It is considered the risk phrase R35 'Causes severe burns' should be assigned to MODA.

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:

Based on the physical characteristics of this test substance it is likely that it will be absorbed dermally, and will produce high pH values when in contact with moisture either from the skin or the ocular environment. The oral gavage studies indicate that aqueous preparations of the test substance resulted in trauma (gastrointestinal haemorrhage, erosion and ulceration) and adaptive changes (mucosal hyperplasia in the fore-stomach associated with oedema and cellular infiltration) which are considered to be due to the administration of a strongly alkaline preparation.

Conclusions:

It is considered that performing irritancy studies via the dermal or ocular routes are unlikely to yield any additional data to those already available. It is considered the risk phrase R35 'Causes severe burns' should be assigned to MODA.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Based on the physical characteristics of this test substance it is likely that it will be absorbed dermally, and will produce high pH values when in contact with moisture either from the skin or the ocular environment. The oral gavage studies indicate that aqueous preparations of the test substance resulted in trauma (gastrointestinal haemorrhage, erosion and ulceration) and adaptive changes (mucosal hyperplasia in the fore-stomach associated with oedema and cellular infiltration) which are considered to be due to the administration of a strongly alkaline preparation.

Justification for selection of skin irritation / corrosion endpoint:
strongly caustic

Justification for selection of eye irritation endpoint:
strongly caustic

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

It is considered that performing irritancy studies via the dermal or ocular routes are unlikely to yield any additional data to those already available. MODA has been assigned Skin Corr 1A with hazard statement H314 'Causes severe skin burns and eye damage'.