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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other: TSCAT submission
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Inhalation Risk Test
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 2-methylbutyric acid
- Analytical purity: 97.9%
- Impurities (identity and concentrations): valeric acid 1.8%; unidentified 0.3%
- Stability under test conditions: shell life > 6 months
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: animal chmaber
- Exposure chamber volume: 100 to 152 L
- Method of holding animals in test chamber: in cage
- Source and rate of air: air in the exposure chamber
- System of generating atmosphere: 100 g of the test material was placed in the sealed exposure chamber for approx. 18 hours. A mixing fan periodically agitated the chamber atmosphere to aid in distribution of the vapour. Oxgen was added, as needed, to maintain approx. 20% of oxygen.


Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
saturation
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 0 (prior to treatment), 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
none

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
8 375 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: There were no signs of toxicity and no gross lesions at necropsy.
Mortality:
No death during exposure or thereafter
Clinical signs:
None noted
Body weight:
Increase in males from 280 g on day 0 to 339 g on day 14. No significant body weight gain in females (237 g before treatment, 244 g at day 14 (all values means).
Gross pathology:
No gross lesions noted

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Male and female rats (5 per sex) survived a 6-hour whole body exposure to a saturated vapour atmosphere. There were no deaths within the 14-day observation period. There were no clinical signs of toxicity at any time, or gross lesions at terminal sacrifice. According to EC/1272/2008 table 3.1.1 the substance is not acutely toxic after inhalation.
Executive summary:

Male and female rats (5 per sex) survived a 6-hour whole body exposure to a saturated vapour atmosphere. There were no deaths within the 14-day observation period. There were no clinical signs of toxicity at any time, or gross lesions at terminal sacrifice.