Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
Cross-reference
Reason / purpose for cross-reference:
assessment report

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
EC Number:
911-428-0
IUPAC Name:
Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax
Test material form:
solid: flakes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Montan wax, type E

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In reliable studies members of the category of Montan waxes proved to be not not toxic to rats after dermal exposure (LD50 > 2000 mg/kg).
Executive summary:

The study used as source investigated the acute dermal toxicity of a member from the category of Montan waxes.

The study results of the source compounds were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and

applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.