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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: extrapolation from results obtained by the oral route
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.

Data source

Reference
Reference Type:
other: extrapolation
Title:
Unnamed
Year:
2013

Materials and methods

Principles of method if other than guideline:
Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
GLP compliance:
no
Test type:
other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.

Test material

Constituent 1
Reference substance name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
EC Number:
309-913-1
EC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
Cas Number:
101357-16-8
Molecular formula:
Not applicable. Multiconstituent substance.
IUPAC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 600 mg/kg bw

Any other information on results incl. tables

Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the dermal route.

From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is greater than 5200 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be greater than 2600 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the assumptions for the extrapolation from the acute oral toxicity data, the dermal LD50 would be greater than 2600 mg/kg bw.
Executive summary:

From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is greater than 5200 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be greater than 2600 mg/kg bw.

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