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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:
From 22 March 1990 to 22 May 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study to GLP, but with no information on test substance purity.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tributoxyethylphosphat
- Analytical purity: no data
- Impurities (identity and concentrations): not available

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, sPF-Zucht
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Males: 181-198 g; Females: 168-190 g
- Fasting period before study: no data
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 =/-2
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:
3.3, 3.4 and 6.4 mg/l measured concentrations
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations twice daily; weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.4 mg/L air
Exp. duration:
4 h
Mortality:
None
Clinical signs:
other: All rats exhibited depressed and irregular breathing, increased salivation, sneezing, unsteadiness and tremor; all clinical signs of toxicity and symptoms had resolved in the majority of animals by day 9 of the observation period.
Body weight:
No effects
Gross pathology:
No macroscopically visible effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute inhalation LC50/4h of TBEP in Sprague-Dawley rats was greater than 6.4 mg/l for males and females.
TBEP is not classified for inhalation toxicity according to the criteria of Annex VI Directive 67/748/EEC or EU GHS.
Executive summary:

In an acute toxicity study, Wistar rats were exposed nose only to the test substance for 4 hours. The measured aerosol concentrations of test compound were 3.3, 3.4 and 6.4 mg/l. The mass median diameter was determined to be 0.8 to 1.3 microns and the geometric standard deviation was 1.8 to 2.0 microns. 100% of the cumulative mass of the particles collected were found to be aerodynamically equivalent in diameter to 7 microns or less for all groups.

There were no deaths during the study. All rats exhibited depressed and irregular breathing, increased salivation, sneezing, unsteadiness and tremor; all clinical signs of toxicity and symptoms had resolved in the majority of animals by day 9 of the observation period. There was no effect on bodyweight gain and no macroscopic changes were noted at necropsy.

The median lethal inhalation concentration of TBEP in Wistar rats was greater than 6.4 mg/l following nose-only exposure for 4 hours.