Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Link to relevant study records
Reference
Endpoint:
three-generation reproductive toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Isoamyl salicylate and Methyl Salicylate share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.
Reason / purpose for cross-reference:
read-across source
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 75 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
body weight and weight gain
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
75 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
Key result
Dose descriptor:
NOAEL
Generation:
F2
Effect level:
ca. 75 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
body weight and weight gain
Key result
Reproductive effects observed:
yes
Lowest effective dose / conc.:
150 mg/kg bw/day (nominal)
Treatment related:
yes
Relation to other toxic effects:
reproductive effects in the absence of other toxic effects
Dose response relationship:
yes
Conclusions:
Isoamyl salicylate may be consider as no toxic for this endpoint since the results for the methyl salicylate in an three generation reproductive study was negative.
Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
75 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Substance tested is structural analogue, Methyl salicylate.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

ddress toxicological endpoints as part of the REACH registration of Isoamyl Salicylate (Target Substance) it is proposed to read-across to Methyl Salicylate (Source Substance).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substance have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling , it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.

See Section 13.

Additional information