Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test guideline (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
400-410-3
EC Name:
-
Cas Number:
25485-88-5
Molecular formula:
C13H16O3
IUPAC Name:
cyclohexyl 2-hydroxybenzoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on mating procedure:
Monogamous mating by combined housing during 21 day period until sucessful mating confirmed
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Males 10 weeks prior to mating and throughout mating up to sacrifice (i.e. 14 weeks of treatement).
Females 2 weeks prior to mating and throughout mating, gestation and lactation up to weaning on, or shortly after, 21 day post partum
Frequency of treatment:
Daily
Details on study schedule:
See duration/treatment
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 60, 180 and 540 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
24 per sex and per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
>= 180 mg/kg bw (total dose)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Significiant reduced weight gain, significantly reduced food intake, increased liver weights, liver swelling, stomach reddening, dystocia in pre-birth dams, increased pre-birth loss at 540mg/kg

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 180 mg/kg bw (total dose)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Generalised pup effects at 540mg/kg bw

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL of 180mg/kg determined for parents and F1 generation. Clear maternal toxicity was seen at the top dose.