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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, meeting current standards, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Study performed according to internal company standards (BASF-test) before actual guideline was adopted.
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): methanol
- Analytical purity: 99.8% (Merck)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA, laboratory animal breeding, Sulzfeld, Germany)
- Weight at study initiation: 185 ± 85 g
- Diet (e.g. ad libitum): Herilan MRH (H. Eggersmann KG, Rinteln, Germany)
- Water (e.g. ad libitum): tap water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose-head inhalation system
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
analytical / nominal concentration:
87.6 / 127 mg/L
115.9 / 159 mg/L
139.0 / 168 mg/L
150.9 /193 mg/L
151.1 / 242 mg/L
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: daily; weighing: before inhalation exposure, 7 and 14 days after inhalation exposure
- Necropsy of survivors performed: yes
Statistics:
probitanalysis [D.J. Finney, 1971, published by the Syndics of the Cambrigdge University Press]

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
128.2 mg/L air
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
130.7 mg/L air
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
> 115.9 mg/L air
Exp. duration:
4 h
Mortality:
At 87.6 mg/L (analytical value) methanol, no mortality was observed.
Mortally contamined animals died within 5 days after substance administration.
Clinical signs:
Mainly in the high concentrations (115.9 - 151.1 mg/L, analytical), where also mortability occurred following clinical symptoms were described: aqueous secretion of eyes and nose, closed eyes, laboring breathing, stagger, apathy, narcosis, prone position, opacity of the cornea. At 87.6 mg/L (analytical value) methanol, clinical symptoms as described for the high concentrations were observed, but no narcosis. 2 days after exposure the animals of the lowest exposed group had no findings.
Body weight:
At concentrations of 150.9 mg/L methanol (analytical value), the body weight of the male animals was reduced at 33 %.
Gross pathology:
Necropsy of deceased animals showed cardiac dilatation and hyperaemic congestion as well as pulmonary edema with extended or scattered hyperaemia. Necropsy of sacrificed animals showed no findings.

Any other information on results incl. tables

At 87.6 mg/L (analytical value) methanol, no mortality was observed.

 concentration [mg/L]   lethality (died animals/exposed animals)  lethality (died animals/exposed animals)
analytical   male  female
151.1 10/10  10/10 
150.9 8/10  10/10 
139.0 6/10  10/10 
 115.9  2/10     1/10 

Applicant's summary and conclusion