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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed according to OECD guidelines and according to GLP principles. The data relating to the purity and stability of the test material are not mentioned in the test report but can be retrieved from the original NONS notification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 403 (1981)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
_ Name of test substance: MCP 1094
- Lot number: CRU# 98432
- Purity: not indicated
- Physical state: yellow liquid
- Expiration date: 5 November 2003

Physical form of substance: L
Mass median aerodynamic diameter (for liq.+solid aerosol):
2.02 microns with a geometric standard deviation of 2.34.

20% of particles were =< 1.0 micron,

79% of particles were =< 4.0 micron

97% of particles were =< 10.0 micron

Test animals

Species:
other: Sprague-Dawley Crl:CD (R) (SD) IGS BR Rats
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: None
Details on inhalation exposure:
nose-only exposure
Duration of exposure:
4 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.33 mg/L air
Exp. duration:
4 h
Mortality:
Male: 5.33 mg/L; Number of animals: 10; Number of deaths: 0
Male: 0 mg/L; Number of animals: 10; Number of deaths: 0
Female: 5.33 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No signs of toxicity were noted during the exposure period.

Signs of toxicity noted immediately following the exposure
were secretory responses (chromodacryorrhea, red nasal
discharge and dried red material on the facial area) and
moist rales. Wet fur and matted coat were also noted but
were considered artefacts of the nose-only exposure regimen.
A few observations similar to those noted immediately
following the exposure were seen for up to 2 days after the
exposure. Most animals were unremarkable thereafter.
Gross pathology:
Effects on organs:
There were no test substance exposure related macroscopic
findings.

There were no test substance exposure related microscopic
findings.

Any other information on results incl. tables

Comments:
Two days after exposure 5 males from the control and treated
group were sacrificed and their lungs examined.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU