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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: Comparable to guideline study with restrictions (pre-GLP): concentration was measured, but not humidity, temperature and particle size.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
BASF test
GLP compliance:
no
Remarks:
gas chromatography
Test type:
other: dynamic head-nose exposure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromin C 260
- Physical state: yellowish liquid
- Analytical purity: > 98 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA, Sulzfeld and MUS RATTUS, Brunnthal, Germany
- Weight at study initiation: 185±15 g (mean)
- Diet: Herilan MRH (H. EGGERSMANN KG) ad libitum
- Water: tap water ad libitum

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:
0.053, 0.31, 0.41, 0.62 mg/l (analytical concentration) [0.31, 1.41, 1.83, 2.13 mg/l (nominal concentration)]
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Statistical evaluation included a probit analysis accordinmg to D.J. Finney.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
0.42 mg/L air (analytical)
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
0.44 mg/L air (analytical)
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
0.4 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
0.62 mg/l air: 9/10 (males); 10/10 (females)
0.41 mg/l air: 3/10 (males); 5/10 (females)
0.31 mg/l air: 2/10 (males); 1/10 (females)
0.053 mg/l air: 0/10 (males); 0/10 (females)
Clinical signs:
other: Animals showed apathy, staggering, squatting and abdominal position, ruffled fur and in general clinical symptoms that were indicative of a marked irritant effect on the airways and eyes such as eyelid closure, watery eye and nose discharge and corneal op
Body weight:
Some retardation in body weight gain was observed in the treated animals during the post observation. However, there was no clear dose-response and body weights were not statistically significantly different from control at the end of the postobservation period.
Gross pathology:
Animals that died:
heart: acute dilatation of the right ventricle, acute congestive hyperemia;
lungs: focal hyperemia, additional moderate edema;

Sacrificed animal: no pathologic findings noted.

Any other information on results incl. tables

Test concentrations and mortality:

Dose (mg/l)   male  female      
 0.62  9/10  10/10      
 0.41  3/10  5/10      
0.31  2/10  1/10      
 0.053  0/10  0/10      

Body weight:

Mean body weight (in g)   male        female     
   0 days  7 days  14 days  0 days  7 days  14 days
0.62 mg/l 189 (10) 196 (1) 233 (1) 178 (10) - -
0.41 mg/l  180 (10) 166 (7) 233 (7) 177 (10) 188 (5) 209 (5)
0.31 mg/l 181 (10) 189 (8) 234 (8) 184 (10) 185 (9) 198 (9)
0.053 mg/l 190 (10) 202 (10) 240 (10) 184 (10) 189 (10) 203 (10)
control 182 (10) 220 (10) 253 (10) 175 (10) 182 (10) 194 (10)

(): number of animals;

"-": all animals dead.

Applicant's summary and conclusion