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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effects on fertility

Description of key information

Montan wax, type S was tested in a reliable study (RL1, according to OECD guideline 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) and Montan wax, type E in a Reproduction/Developmental Toxicity Screening Test according to OECD guideline 421). No effects were observed in both rat studies at the highest doses of 1000 mg/kg bw/day tested.

Link to relevant study records

Referenceopen allclose all

Endpoint:
screening for reproductive / developmental toxicity
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”.
Reason / purpose for cross-reference:
assessment report
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment-related effects were observed
Remarks on result:
other: Montan wax, type E
Critical effects observed:
no
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment-related effects were observed
Remarks on result:
other: Montan wax, type E
Critical effects observed:
no
Reproductive effects observed:
no
Conclusions:
Under the conditions of this Reproduction/Developmental Toxicity Screening study, no treatment-related effects were observed up to 1000 mg/kg bw/day, the highest dose tested.
Executive summary:

The study used as source investigated reproduction/developmental toxicity to rats. The study results of the source compound

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”.

Endpoint:
screening for reproductive / developmental toxicity
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”.
Reason / purpose for cross-reference:
assessment report
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment-related effects were observed
Remarks on result:
other: Montan wax, type S
Critical effects observed:
no
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no treatment-related effects were observed
Remarks on result:
other: Montan wax, type S
Critical effects observed:
no
Reproductive effects observed:
no
Conclusions:
Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, no treatment-related effects were observed up to 1000 mg/kg bw/day, the highest dose tested.
Executive summary:

The study used as source investigated reproduction/developmental toxicity to rats. The study results of the source compound

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”.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Reliable studies (Klimisch score 1) are available for members of the montan wax category
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Different Montan waxes and structurally related substances were tested with respect to effects on reproduction and developmental toxicity, including Reproduction/Developmental Toxicity Screening Tests, a two-generation study and developmental toxicity studies in two species. The available information does not raise a concern with respect to reproductive or developmental effects of the Montan waxes.

Reproduction and fertility

Montan wax, type S was tested in a reliable study (RL1, according to OECD guideline 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) and Montan wax, type E in a Reproduction/Developmental Toxicity Screening Test according to OECD guideline 421). No effects were observed in both rat studies at the highest doses of 1000 mg/kg bw/day tested.

A two-generation study is available, where rats were exposed to Policosanol (origin: sugar cane wax; mostly even numbered long chain fatty alcohols (C24-C34), mainly octacosanol (C28)). This reliable study (RL2) did not observe effects on reproduction or development of offspring in a dose range up to 500 mg/kg bw/day.

 

Please note that studies for the higher tonnage band (>100 tonnes, corresponding to REACH Annex IX and X) and which are included in the CSR and the IUCLID dossiers (lead registrant) of the respective category members are not reported here.

Effects on developmental toxicity

Additional information

Different Montan waxes and structurally related substances were tested with respect to effects on reproduction and developmental toxicity, including Reproduction/Developmental Toxicity Screening Tests, a two-generation study and developmental toxicity studies in two species. The available information does not raise a concern with respect to reproductive or developmental effects of the Montan waxes.

Developmental toxicity

The developmental toxicity was tested in rats in a guideline study (OECD 414) with Montan waxes, type E (RL1), and no adverse effects were observed in dams or foetuses up to 1000 mg/kg bw/day, the highest dose tested. Information on a second species with respect to developmental toxicity comes from a reliable rabbit study (RL2) with the structurally related D-003, and no developmental effects were observed (highest dose tested: 1000 mg/kg bw/day).

Please note that studies for the higher tonnage band (>100 tonnes, corresponding to REACH Annex IX and X) and which are included in the CSR and the IUCLID dossiers (lead registrant) of the respective category members are not reported here.

Justification for classification or non-classification

Based on the findings of reliable studies with different types of Montan waxes, the Montan waxes category members have not to be classified with respect to reproductive or developmental effects according to Regulation (EC) No 1272/2008.

Additional information