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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to
Guideline:
other: EG-Richtlinie 84/449/EWG B.2.
Qualifier:
according to
Guideline:
other: TSCA-Guideline §798.1150
GLP compliance:
yes
Test type:
other: Acute toxicity: inhalation, rat
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99,62 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0; 511; 801; 2140; 4242 mg/m³ air.
No. of animals per sex per dose:
5/sex/dose
Control animals:
yes

Results and discussion

Effect levels
Dose descriptor:
LC50
Effect level:
> 4.242 mg/L air
Exp. duration:
4 h
Mortality:
2 male rats in dose group 4242 mg/L air died.
Clinical signs:
other: Group 3 ( 801 mg/L air) showed piloerection, diminuated motility, difficulties in breathing, bloody snout. Group 4 (2140 mg/L air) showed piloerection, untended fur, diminuated motility, nose secretion, sniffing sounds, bradypnoe, complications in breath
Body weight:
3 days after experiment in the male rats of group 2 (511 mg/L air) a retardation in weight gain and in groups 3 to 5 (801; 2140; 4242 mg/m³ air) a loss of weight could be observed.
Gross pathology:
died intercurrently: inflated, liver-like lung; red-crusted nose; anemic spleen and kidneys; changed liver signing; gastrointestinal trakt filled with yellow mucus.
Animals killed after observation period: inflated lung; effects in spleen (anemic, reduced in volume, enlarged, dark coloured); changed liver signing; inflated intestine.

Any other information on results incl. tables

Acute toxicity: inhalation: aerosol

 N  Concentration nomin. analyt.    mg/m³ air  Toxicological result        Duration of symptoms  Timepoint od death  Particle < 5 µm (%)
                         Male rat
 1     air-control  0*  0**  5***  -  -  -
 2  2425  511  0  0  5  -  -  100
 3  9700  801  0  5  5  4h-6h  -  100
 4  13400  2140  0  5  5  4h-7h  -  100
 5  48500  4242  2  5  5  4h-28d  2d  100
                         Female rat
 1     air-control  0  0  5  -  -  -
 2  2425  511  0  0  5  -  -  100
 3  9700  801  0  5  5  4h-6h  -  100
 4  19400  2140  0  5  5  4h-4d  -  100
 5  48500  4242  0  5  5  4h-7d  -  100

LC50 male: approx. 4242 mg/m ³ air.

N= Group number

4h= direktly after exposition

*= Number of mortalities

**= Number of animals with symptoms

***= Number of animals used

Applicant's summary and conclusion

Executive summary:

Acute inhalative toxicity was tested with the test substance in male and female Wistar rats.

The doses tested for 4 hours were: 0; 511; 801; 2140; 4242 mg/m³ air.

Observed symptoms: diminuated motility, ataxie, adynamia in hindpaw, prostration, piloerection, untended fur, nose secretion, sniffing sounds, difficulties in breathing, bradypnoe, breathing sounds, chromodacryorrhoe, red-coloured urine, inflated abdomen, bloddy snout, loss of myotactic reflex, reduction of body weight.

After 4242 mg/m³ air 2 of 5 male rats died; the female rats in this dose group showed no mortalities.

The LD 50 was approx. 4242 mg/m³ air in the the more sensitive male rat.