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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl acrylate
EC Number:
216-768-7
EC Name:
tert-butyl acrylate
Cas Number:
1663-39-4
Molecular formula:
C7H12O2
IUPAC Name:
tert-butyl acrylate
Specific details on test material used for the study:
- Name of test material: Tertiaerbutylacrylat
- Physical state: clear liquid
- Analytical purity: ca. 99.5 %
- Impurities: stabilized with 15 ppm Hydrochinonmonomethylether

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga, Sulzfeld, D (SPF breeding)
- Weight at study initiation: 185 ± 15g
- Fasting: no
- Diet (ad libitum): Herilan MRH (H. Eggersmann KG, Rinteln, D)
- Water (ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- standardized conditions (unspecified)

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: permanent infusion pump (UNITA)
- Exposure chamber volume: 200 L
- Source and rate of air: 3000 - 3100 L/h
- System of generating particulates/aerosols: heatable vaporisator, electric (BASF)
- Treatment of exhaust air: vacuum system with underpressure (9.8 Pa)

TEST ATMOSPHERE
- Brief description of analytical method used: GC HP 5840 A, detector: FID; the atmosphere was absorbed with propanol-2 in two wash bottles in serial configuration; ca. 1 L/min
- Samples taken from breathing zone: yes

CLASS METHOD
- Rationale for the selection of the starting concentration: based on results of an inhalation hazard test
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
8.78; 7.42; 6.30; 5.35; 5.24; 2.96 mg/L (analytical concentrations, vapour)
No. of animals per sex per dose:
20
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighing was performed on d0, d7 and d14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis (Finney, 1971)

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
7.01 mg/L air (analytical)
95% CL:
6.65 - 7.45
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
7.3 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: no confidence interval calculated due to inadequate homogeneity
Sex:
male
Dose descriptor:
LC50
Effect level:
6.75 mg/L air (analytical)
95% CL:
6.3 - 7.32
Exp. duration:
4 h
Mortality:
- 8.78 mg/L: 20/20
- 7.42 mg/L: 11/20
- 6.30 mg/L: 3/20
- 5.35 mg/L: 1/20
- 5.24 mg/L: 2/20
- 2.96 mg/L: 0/20
- control: 0/20
See table for details
Clinical signs:
other: Attempts to escape, lid closure, reddish eye and nose discharge, crusted nose and eyes, accelerated or intermittend respiration, high-stepping or unstable gait, squatting posture, reduced motility, tremor, reddish ears and extremities, ruffled fur. Signs
Body weight:
Males of the 7.42 mg/L treatment had a ca. 40% lower weight gain after 14 d if compared with the control. The mean body weight gain of the females in all treatment groups was somewhat lower than the control in the first observation week, while their weight gain was comparable with the control in the second week.
See table for details
Gross pathology:
Animals that died: generally: acute heart dilatation, acute congestion hyperemia; highest dose group: liver with rare and slight broadening of the lobules; lower doses: in some animals slight acute lung dilution
Sacrificed animals: nothing abnormal found

Any other information on results incl. tables

Cumulated mortality

Dose (mg/L)

sex

after 7 d

after 14 d

8.78

male

10/10

10/10

female

10/10

10/10

7.42

male

7/10

7/10

female

4/10

4/10

6.30

male

3/10

3/10

female

0/10

0/10

5.35

male

0/10

0/10

female

0/10

0/10

5.24

male

0/10

0/10

female

2/10

2/10

2.96

male

0/10

0/10

female

0/10

0/10

control

male

0/10

0/10

female

0/10

0/10

Body weight (g)

Dose (mg/L)

sex

at d 0

after 7 d

after 14 d

Body weight gain (14d; g)

8.78

male

192

female

181

7.42

male

196

202

231

35

female

173

184

196

23

6.30

male

182

210

238

56

female

179

289

192

13

5.35

male

181

218

256

75

female

180

185

191

11

5.24

male

187

214

247

60

female

184

187

202

18

2.96

male

188

224

269

81

female

184

193

209

25

control

male

193

220

249

56

female

185

200

213

28

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria