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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

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:
1976
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:
2003
Bibliographic source:
SIDS Initial Assessment Report for SIAM 16

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

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:
- Origin: Elf Atochem S.A.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca 2.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours, unresorbed quantity determined
Duration of exposure:
24 hours
Doses:
9200; 13850; 23000; 23000; 32300 mg
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Remarks on result:
other: according to the authors, as cited in OECD SIDS
Mortality:
Number of deaths and time at each dose:
9.2 g dose (0.6 ± 0.4 g/kg absorbed): none
13.85 g dose (0.75 ± 0.5 g/kg): 2 after 6 and 12 hours, resp.
23 g dose (1.7 ± 0.9 g/kg): 3 after 3, 4, and 5 hours, resp.
23 g dose (2.85 ± 1.3 g/kg): 3 after 4, 6, and 48 hours, resp.
32.3 g dose (2.5 ± 1 g/kg): 6 after 2.5, 4x4, 5 hours, resp.
Clinical signs:
other: Accelerated breathing, prostration, narcosis, death (mostly within 6 hours) or recovery. The intensity of the erythema varied between animals. Recovery of the skin was not always complete within the postexposure period. Doses at which clinical signs appea

Any other information on results incl. tables

RS-Freetext:
MORTALITY
Dose absorbed deaths timepoint
[mg] [mg/kg] [hours]
---------------------------------------------------
9200 600 ± 400 0/6 -
13850 750 ± 500 2/6 6, 12
23000 1700 ± 900 3/6 3, 4, 5
23000 2850 ± 1300 3/6 4, 6, 48
32300 2500 ± 1000 6/6 2.5, 4 x 4, 5

LD50: 1200 mg/kg bw (according to OECD SIDS)

CLINICAL SIGNS
Animals showed accelerated breathing, prostration and narcosis.
Death occured mostly within 6 hours, but survivors recovered.
The intensity of the erythema varied between animals, recovery of the skin was not always complete within the postexposure period.
Doses at which clinical signs appeared were not defined in the study.

POTENTIAL TARGET ORGANS
None identified (except skin).

SEX-SPECIFIC DIFFERENCES
None identified.

Applicant's summary and conclusion