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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study. Some details on methods / results not available

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 hours exposure to maximum aerosol concentration achievable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexane-1,2-dicarboxylic anhydride
EC Number:
201-604-9
EC Name:
Cyclohexane-1,2-dicarboxylic anhydride
Cas Number:
85-42-7
Molecular formula:
C8H10O3
IUPAC Name:
octahydro-2-benzofuran-1,3-dione
Test material form:
gas: vapour

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
VEHICLE
- Composition of vehicle (if applicable): Ethanol
- Concentration of test material in vehicle (if applicable): 80%
- Justification of choice of vehicle: Substance stable in selected vehicle

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 75% of the particles were less than 10 μm indicating a respirable aerosol.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 5.8 μm (GSD = 2.2).
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
1100 mg/m3
No. of animals per sex per dose:
5 male / 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - Daily; Body weights - Days 3, 4, 5, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
1 100 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 100 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: Decreased activity noted during exposure.
Body weight:
Depressed during the first week, followed by recovery during second week.
Gross pathology:
Not remarkable

Applicant's summary and conclusion

Conclusions:
Acute inhalation toxicity following 4 hours exposure to the highest achievable aerosol concentration has been investigated in the rat. The LC50 was in excess of 1100 mg/m³.
Executive summary:

Acute inhalation toxicity following 4 hours exposure to the highest achievable aerosol concentration has been investigated in the rat. The LC50 was in excess of 1100 mg/m³.