Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Methyloctane-1,8-diamine
EC Number:
700-111-0
Cas Number:
148528-05-6
Molecular formula:
C9H22N2
IUPAC Name:
2-Methyloctane-1,8-diamine

Results and discussion

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.

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