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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: 20-weeks repeated dose toxicity study
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability 2 is assigned because the information is based on a reliable subchronic repeated dose toxicity study predating OECD Guidelines and GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity
Author:
Hagan et al.
Year:
1967
Bibliographic source:
Hagan E.C., Hansen W.H., Fitzhugh O.G., Jenner P.M., Jones W.I., Taylor J.M., Long E.L., Nelson A.A., and Brouwer J.B. (1967) Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity, Food Cosm. Toxicol., 5, 141-157.  

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Deviations:
yes
Remarks:
Most parameters have been evaluated according to current guidelines but not all.
Principles of method if other than guideline:
See repeated dose toxicity section
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-menth-1-en-8-yl acetate
EC Number:
201-265-7
EC Name:
p-menth-1-en-8-yl acetate
Cas Number:
80-26-2
Molecular formula:
C12H20O2
IUPAC Name:
1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
See repeated dose toxicity section.

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
See repeated dose toxicity section.
Details on mating procedure:
Not applicable
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
See repeated dose toxicity section.
Duration of treatment / exposure:
20-weeks
Frequency of treatment:
Dietary dosing
Details on study schedule:
See repeated dose toxicity section.
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
nominal in diet
1000, 2500 and 10000 ppm
No. of animals per sex per dose:
10/sex/dose

Examinations

Parental animals: Observations and examinations:
See repeated dose toxicity section.
Oestrous cyclicity (parental animals):
No information
Sperm parameters (parental animals):
No information
Litter observations:
Not applicable
Postmortem examinations (parental animals):
See repeated dose toxicity section.
Postmortem examinations (offspring):
Not applicable
Statistics:
See repeated dose toxicity section.
Reproductive indices:
Not applicable
Offspring viability indices:
Not applicable

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Description (incidence and severity):
See repeated dose toxicity section.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
See repeated dose toxicity section.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
See repeated dose toxicity section.
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
See repeated dose toxicity section.
Other effects:
effects observed, treatment-related

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
not specified

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
>= 400 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects were seen on male and female gonads in a 20-week dietary study similar to OECD TG 408, which leads to the conclusion that there are no effects on male and female fertility

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No effects were seen on male and female gonads after 20-weeks of administration of the test substance
Executive summary:

See repeated dose toxicity section.