Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04.05.1988 - 18.05.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1988
Report Date:
1988
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report - 2-Methylbut-3-yn-ol
Author:
BASF AG
Year:
2002
Bibliographic source:
OECD SIDS
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Methylbutin-3-ol-2
- Product No.: 064 522
- Date of bottling: Nov, 1987
- Physical state: liquid, colorless
- Analytical purity: 99.6%
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr . K . Thomae GmbH, 7950 Biberach
- Age at study initiation: ca. 8 - 9 weeks
- Weight at study initiation: male 259 +/- 6.4 g (average), female 185 +/- 6.5 g (average)
- Identification: colormark on tail
- Housing: 5 per cage, Type D III, Firma Becker
- Diet (e.g. ad libitum): ad libitum, KLIBA Labordiät Ratte/Maus, 24-343-4 10 mm Pellet, Klingentalmühle AG, CH-4303 Kaiseraugst
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

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: steel cage placed in Inhalation chamber made of glass and steel
- Exposure chamber volume: ca. 200l
- Method of holding animals in test chamber: single housing
- Source and rate of air: 3000 l/h, central air conditioning system
- System of generating particulates/aerosols: dosing-pump (DESAGA) and glass-vapourizer attached to air-conditioning system
- Temperature, humidity, pressure in air chamber: 20 - 24 °C, 30 - 70% humidity


TEST ATMOSPHERE
- Brief description of analytical method used: Two beakers connected to a fritted glass beaker filled with the solvent 2-propanol.
- Samples taken from breathing zone: yes, once per hour sample, analyzed by gas chromatography with a GC HP 5840A (Hewlett Packard)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by gas chromatography and substance weight loss during exposure
Duration of exposure:
4 h
Concentrations:
21.3 mg/l
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: prior to begin of study, after 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
statistic was calculated acc. binominal model

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 21.3 mg/L air
Exp. duration:
4 h
Mortality:
no deaths occured
Clinical signs:
- During exposition: accelerated and intermittent respiration, narcotic-like condition, lateral position, anemic pallor
- until day 8: Abdominal or lateral position, narcotic-like condition, accelerated to intermittent respiration, reduced general state, apathy, ataxia, piloerection, red crusted eyelid, anogenital region smeared with urine
- from day 9: no clinical signs
Body weight:
Body weight gain was delayed in the first week compared to historical control, but equals in the second week.
- average weight prior to begin of study: male 259 g, femal 185 g
- average weight after 7 days: 275 g, 198 g
- average weight after 14 days: 315 g, 208 g
Gross pathology:
no findings

Applicant's summary and conclusion

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