Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
calculation (if not (Q)SAR)
Remarks:
Review
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Because the substance is in part polymer, assessment of toxicity has been carried out through consideration of the constituents and fragements found during MS analysis. This was considered to be a viable alternative to animal testing.
New animal studies cannot be justified on a class of high molecular weight amines where the low molecular weight fragments and reaction products are of low toxicity.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Review of information from different sources
GLP compliance:
not specified
Remarks:
Some sources of information may have been GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Named in some reports as 2-propenenitrile, polymer with 1,2-ethanediamine
Dried material, described as viscous liquid, is used for some tests.
Specific details on test material used for the study:
Review based on consistuents and fragments identified in Section 1.2 of the dossier

Test animals

Species:
rat
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
In view of potential corrosivity, vehicles were important in some cases to avoid local irritation masking systemic effects

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None reported
Clinical signs:
Other than local irritation, not reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Except where the low moleuclar weight amines were severely irritant, there was no effect on toxiciy.