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Diss Factsheets

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:
16. Feb. 1979 - 27. Apr. 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
other: trade name
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid, C12-15-alkyl esters
EC Number:
270-112-4
EC Name:
Benzoic acid, C12-15-alkyl esters
Cas Number:
68411-27-8
Molecular formula:
C19-22 H30-36 O2
IUPAC Name:
Benzoic acid, C12-15-alkyl esters

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey
- Weight at study initiation: 200 -246 g
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation: animals were conditioned prior to use

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plastic chamber
- Exposure chamber volume: three-cubic-foot
- Source and rate of air: preconditioned supportive air at 5 L/minute
- System of generating particulates/aerosols: Preconditioned supportive air was supplied and the test material was presented from a compressor activated generator or timer operated solenoid to continue a nominal chamber concentration of 200 mg / liter air

TEST ATMOSPHERE
- nominal concentration of 200 mg / liter air

VEHICLE
- Composition of vehicle (if applicable): air
- Concentration of test material in vehicle (if applicable): 200 mg / liter air
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
200 mg / liter air
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily (1, 3, 6, 24 hours after exposure on day 1) and weighing at start and end of the experiment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight , necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 200 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:

Dose Level (mg/l) Sex # dead /# dosed Mortality ( %)
200 5 M : 5 F 1/5 : 0/5 10

Clinical signs:
other: Slight depression observed 1 hour after exposure at all 10 animals, otherwise no abnormal clinical signs within 14 days after exposure.
Body weight:
Body weight gain at 9 survived animals 14 days after exposure.
Body weight loss at 1 animal that died on 9th day after exposure.
Gross pathology:
Animal #1: All lobes of right lung enlarges and consolidated. Animal died on day 9.
Animals #2 - #10: No gross changes observed.

Any other information on results incl. tables

 

Dose

(mg/l

Animal No.

and Sex

Body

weight

(g)

Hours:

 

1    3    6   24

Days:

 

2   3    4   5   6   7 --14

Body

weight

(g)

200

1 M

202

SD

N

N

N

N

N

N

N

N

N+  -

156

200 

2 M

230

SD

N

N

N

N

N

N

N

N

N    N

296

 200

3 M

232

SD

N

N

N

N

N

N

N

N

N    N

324

 200

4 M

230

SD

N

N

N

N

N

N

N

N

N    N

290

 200

5 M

246

SD

N

N

N

N

N

N

N

N

N    N

312

 200

6 F

204

SD

N

N

N

N

N

N

N

N

N    N

222

 200

7 F

200

SD

N

N

N

N

N

N

N

N

N    N

226

 200

8 F

200

SD

N

N

N

N

N

N

N

N

N    N

262

 200

9 F

200

SD

N

N

N

N

N

N

N

N

N    N

210

 200

10 F

200

SD

N

N

N

N

N

N

N

N

N    N

220

 

N  = Normal

SD = Slight Depression

+ = Animal Death 

Animal No. 1: All lobes of right lung enlarges and consolidated; died on day 9.

Animal No. 2-10: No gross changes observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the Acute Inhalation Toxicity study on Wistar-derived rats the LC50 of the test material was determined as being > 200 mg/l.
There was a 10% mortality observed in the exposed rats. Under the conditions if this study the test material is considered to be not toxic by inhalation to rats.
Executive summary:

In an Acute Inhalation Toxicity study ten albino rats (5M:5F, 200 -246 g body weight) were exposed to concentrations of 200 mg test material / liter air for 1 hour and observed for two weeks. Mortality, clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.  

Mortality: 10 % (1/10 animals)

Clinical Observations: Slight depression was observed at all animals 1 h after exposure; otherwise no abnormal clinical signs within 14 days observation period.

Body weight: Body weight gain at 9 animals after the 14 days observation period, body weight loss at 1 animal that died after exposure.

Necropsy: No gross changes observed at 9 animals. In the one dead animal all lobes of right lung enlarges and consolidated.

Conclusion: The LC50 of the test material was determined as being > 200 mg/l. Under the conditions if this study the test material is considered to be not toxic by inhalation.