Registration Dossier

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

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)
GLP compliance:
no
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): Dimethylacrolein, Substance-No. 78/452
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 185 +/- 15
- Diet: Herilan MRH ad libitum
- Water ad libitum



Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body inhalation system
- Exposure chamber volume: 200 l
- Source and rate of air: 200 l/hour
- Temperature, pressure in air chamber: 20°C, 761-763mbar
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.97, 3.15, 3.59, 3.88, 6.08 mg/l (970, 3150, 3590, 3880, 6080 mg/m³)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: at study initiation, on day 7 and 14
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Probit-Analysis according to Finney (p. 1-150, Cambridge Univerity Press, 1971)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
3.7 mg/L air
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
14.8 mg/L air
Exp. duration:
1 h
Remarks on result:
other: calculated according to Haber's rule: c*t=k
Sex:
male
Dose descriptor:
LC50
Effect level:
3.5 mg/L air
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
4 mg/L air
Exp. duration:
4 h
Mortality:
Dose Dead animals/out of total
0.97 mg/l 0/20
3.15 mg/l 0/20
3.59 mg/l 9/20
3.88 mg/l 13/20
6.08 mg/l 20/20
Clinical signs:
Animals from the 2 lowest dose groups recovered within 5 days from signs which included lacrimation and nasal discharges, closed lids, labored breathing, unkept fur. Signs were more pronounced in animals receiving higher doses and included dyspnoea, unsteady gait, stagger, apathia, tremors, opacity of cornea. Deaths occurred within 5 days after exposure. Survivors were not free of symptoms when sacrificed at the end of the 14 day observation period.
Body weight:
Mean group body weights were reduced in a dose-dependent manner in both sexes 7 days after dosing. 14 days after dosing body weights of female survivors were not different from controls. This applies also to the male animals except for the 3.88 dosing group. Mean body weight of this group was reduced by approx. 11% when compared with control animals.
Gross pathology:
animals that died: acute heart dilatation in atrei and acute congestion. Several victims showed peripheral lobular pattern in liver and edematous lungs. sacrificed animals: nothing abnormal detected

Any other information on results incl. tables

Mean body weight

day 0

day 7

day 14

male

female

male

female

male

female

control

weight (g)

number of animals

0

10

0

10

+44

10

+19

10

+72

10

+32

10

Group 1

weight (g)

number of animals

-

-

-

-

-

-

Group 2

weight (g)

number of animals

0

10

0

10

-8

1

-15

6

+51

1

+29

6

Group 3

weight (g)

number of animals

0

10

0

10

-2

3

+9

8

+60

3

+36

8

Group 4

weight (g)

number of animals

0

10

0

10

+26

10

+17

10

+66

10

+19

10

Group 5

weight (g)

number of animals

0

10

0

10

+43

10

+18

10

+83

10

+31

10

Combined male and female LC50 was 3.7 mg/l (3700 mg/m3). LC50 was comparable in males and females (LC50 males 3.5 mg/l, LC50 females 4.0 mg/l).

Symptoms persisted until the end of the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU