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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
BASF-internal standards; estimation of the LC50 value
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.9%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Body weight range of the animals: 185 ± 15 g
The animals were offered Herilan MRH of H. EGGERSMANN KG, Rinteln/Weser, and tap water ad libitum during the post-exposure observation period.
The animals were kept in fully air-conditioned rooms (temperature 22 ± 2°C and humidity 55 ± 5%) with a day/night rhythm of 12 hours.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
A concentration estimated on the basis of the data from the inhalation hazard test was used as a first orientating concentration. One concentration allows a no effect level to be established (0 lethality).
Duration of exposure:
4 h
Concentrations:
6.2 mg/l
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
The body weight of the animals was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings and lethality were recorded daily.
At the end of the 14-day observation period, the animals were sacrificed with CO2 and were subjected to a gross-pathological examination like all other animals which had died before.
Statistics:
Statistical evaluation of the test were done according to the binomal test (BASF SE).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.2 mg/L air
Exp. duration:
4 h
Remarks on result:
other: significance level: 1%
Mortality:
none
Clinical signs:
Watery eye and nose secretion, mouth smearing, intermittent and accelerated breathing, apathetic, narcosis, scrubby fur. Three of 10 female animals showed alopecia. Symptoms were seen until day of killing.
Body weight:
No significant differences to the control group.
Gross pathology:
Sacrificed animals: nothing abnormal detected.

Any other information on results incl. tables

1) LC50 (4 h) for male and female animals: = > 6.2 mg/l air

2) LC50 (1 h) for male and female animals: = > 25 mg/l air*

3) LC50 (4 h) for male animals: = > 6.2 mg/l air

4) LC50 (1 h) for male animals: = > 25 mg/l air*

5) LC50 (4 h) for female animals: = > 6.2 mg/l air 6) LC50 (1 h) for female animals: = > 25 mg/l air*

* By means of converting the values of the 4-hour LC50 according to the rule of Haber C x t = k

Applicant's summary and conclusion

Interpretation of results:
other: The test substance is labelled with R20 (Directive 67/548/EEC)
Remarks:
Criteria used for interpretation of results: EU