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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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is selected as the key study because it includes both males and females, used the test material with the smaller particle size, has been performed according to current Guidelines and according to GLP regulation.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TEPIC-SP, purified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The exact name of the rat strain is Crl:HanWist(GlxBRL)BR
The rats were acclimatized for about 5 days in an animal room with 12-hour dark/light cycle, 21 - 23°C, and a rel. humidity of 55 - 65%.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
4-hour inhalation , followed by a 14-day observation period.
Temperature in the exposure chamber was 17 - 24°C with a rel. humidity of 20 - 65% for control and treated groups.Air flow was 12 litre/min for all groups, oxigen concentration was 19.5 - 21.4 %
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
Nominal: 2.80 mg/L ; measured 1.14 mg/L (group 1)
Nominal: 4.62 mg/L; measured 2.76 mg/L (group 2)
Nominal: 8.16 mg/L; measured: 5.04 mg/L (group 3)
No. of animals per sex per dose:
group 1: 0 males / 5 females
group 2: 0 males / 5 females
group 3: 5 males / 5 females
Control animals:
yes
Statistics:
none

Results and discussion

Preliminary study:
none
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LC50
Effect level:
ca. 1.14 mg/L air (analytical)
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
ca. 5.04 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
Group 1: 1/5 females (day 1)
Group 2: 5/5 femlaes (1 on day 1, 3 on day 2, 1 on day 5)
Group 3: 3/5 females (all on day 3) and 1/5 males (day 7)
Clinical signs:
Coldness , gasping , paleness, piloerection, hunched posture, prostration, noisy respiration, nasal discharge, lethargy, tremors, vocalisation, and semi-closed eyes were observed among all dose groups.
Body weight:
Treated rats lost more weight during the day of exposure than the control rats, but by the end of the observation period all gained similar weight as controls except high dose group animals
Gross pathology:
Lung weights of dead or in extremis killed animals were heavier than those of the controls, but the lungs of surviving rats were comparable to those of the control group.
Other findings:
Apart from discoloration of the lungs and distention of parts of the intestinal tract, no substance -related findings were recorded.

Any other information on results incl. tables

The four - hour acute median lethal dose for female rats was calculated (probit method) to be 1.83 mg/l air.

For Male rats no such value was calculated , but as 2/5 males died at 5.04 mg/L air. The LC 50 is approximately 5 - 6 mg/L

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 of female rats (most sensitive sex) is calculated to be 1.83 mg/L.
The LC50 of male rats is approximately 5-6 mg/L, as only a dose of 5.04 mg/L was tested with 2/5 male rats showing lethal effects
Executive summary:

The LC50 of femlae rats (most sensitive sex) is calculated to be 1.83 mg/L. The LC50 of male rats is approximately 5-6 mg/L, as only a dose of 5.04 mg/L was tested with 2/5 male rats dying upon inhalation of TEPIC-SP with a median aerodynamic diameter of 1.70 - 2.06 micrometers.