3,5,5-trimethylcyclohex-3-en-1-one

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. Limitations of the study: only one dose tested, small group size.

Data source

Reference

Reference 1

Reference Type:

other: thesis

Title:

Contribution a l'etude analytique toxicologique et biochimique de l'isophorone.

Author:

Dutertre-Catella H

Year:

1976

Bibliographic source:

Universite Rene Descartes, Paris

Reference 2

Reference Type:

other: OECD SIDS

Title:

3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1

Author:

OECD SIDS

Year:

2003

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 substance in air. After three months of exposure, exposed males were mated with control and exposed females, control males were mated withcontrol and exposed females. Exposure of females continued throughout gestation and they
were allowed to deliver.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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

IUPAC Name:

3,5,5-trimethylcyclohex-2-en-1-one

Details on test material:

- Analytical purity: not reported
- Other: Origin: Elf Atochem S.A.

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

Remarks:

Doses / Concentrations:
500 ppm = 2873 mg/m3 (saturation) (corresponds to 2.873 mg/l)
Basis:

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)

Details on results (P0)

Body weight:
No difference between exposed and control.

Description, severity, time of onset and duration of clinical signs:
Irritation of eyes and nose (exposed).

Mortality:
No mortalities in control groups.
1/10 of exposed females and 2/10 of exposed males died.

Gross pathology incidence and severity:
Traces of bleeding in lungs of both exposed and control animals.

Histopathology 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.

Effect levels (P0)

1

Dose descriptor:

NOAEC

Effect level:

500 ppm

Sex:

male/female

Basis for effect level:

other: original value

2

Dose descriptor:

NOAEC

Effect level:

2 873 mg/m³ air

Sex:

male/female

Results: F1 generation

Details on results (F1)

Litter size and weights:
7-10 per female, normal behaviour, none dead.

Post natal survival until weaning:
no difference between exposed and control.

Effects on offspring:
no difference between exposed and control observed at necropsy.

Overall reproductive toxicity

Reproductive effects observed:

not specified