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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:
key study
Study period:
19th November 1986 to 3rd December 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: pale yellow solid block
Details on test material:
- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

Test animals

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

Administration / exposure

Route of administration:
inhalation: mist
Type of inhalation exposure:
whole body
Vehicle:
other: water
Mass median aerodynamic diameter (MMAD):
3.4 µm
Geometric standard deviation (GSD):
2
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
240 min
Concentrations:
5 mg/L
No. of animals per sex per dose:
Five/sex/dose
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.5 mg/L air
Based on:
test mat.
Exp. duration:
240 min
Mortality:
None.
Clinical signs:
None.
Body weight:
No change.
Gross pathology:
None.
Other findings:
Chromodacryarrhoea was observed in all animals by the end of the exposure period indicating that the test material could be an ocular irritant. The effect was found to be reversible.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A 4-hour inhalation LC50 of > 5.5mg/L is estimated for the test material based on the absence of mortality or evidence of gross systemic toxicity in SD rats following inhalation exposure.
Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by inhalation exposure at a dose level of 5 mg/L (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LC50 is 5 mg/L.