Registration Dossier
Registration Dossier
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EC number: 201-126-0 | CAS number: 78-59-1
Toxicological information
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Limitations: only one dose tested, small group size
Data source
Referenceopen allclose all
- Reference Type:
- other: thesis
- Title:
- Contribution a l'etude analytique toxicologique et biochimique de l'isophorone.
- Author:
- Dutertre-Catella H
- Year:
- 1 976
- Bibliographic source:
- Universite Rene Descartes, Paris
- Reference Type:
- other: OECD SIDS
- Title:
- 3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 16
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a limited one generation study, rats were exposed to the test substance in air. After three months of exposure, exposed males were mated with control and exposed females, control males were mated with control and exposed females. Exposure of females continued throughout gestation and they were allowed to deliver.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approximately 140 g
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- air
- Details on mating procedure:
- after three months of exposure overnight mating of
5 exposed males with 5 exposed females
5 exposed males with 5 control females
5 control males with 5 exposed females
5 control males with 5 control females
next morning exposure continued for exposed animals (females until littering)
No information on mating success. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: 6 hours/day
Premating exposure period (males): 3 months
Premating exposure period (females): 3 months
Duration of test: females: 4 months; males: 6 months - Frequency of treatment:
- 5 days/week
Doses / concentrations
- Dose / conc.:
- 500 ppm
- Remarks:
- = 2873 mg/m3 (saturation)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- behaviour, body weight development, mortality
- Litter observations:
- number and vitality
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Irritation of eyes and nose (in exposed animals)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No mortalities in control groups.
1/10 of exposed females and 2/10 of exposed males died. - Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Slight to medium congestion in lungs with similar intensity in exposed and control; granular state and clarification of liver cytoplasma with similar intensity in exposed and control.
- Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEC
- Remarks:
- general toxicity
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Remarks on result:
- other: corresponds to 2873 mg/m³
- Dose descriptor:
- NOAEC
- Remarks:
- fertility
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Remarks on result:
- other: corresponds to 2873 mg/m³
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOAEC
- Remarks:
- = 2873 mg/m³
- Generation:
- F1
- Effect level:
- 500 ppm
- Remarks on result:
- other: no adverse effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
