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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:
other: Comparable to guideline study.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980
Reference Type:
other: amendment to acute inhalation toxicity study (Zeller and Klimisch, 1980)
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Formic acid
EC Number:
200-579-1
EC Name:
Formic acid
Cas Number:
64-18-6
Molecular formula:
CH2O2
IUPAC Name:
formic acid
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Ameisensäure.
- Substance number: 78/651
- Source: Merck
- Analytical purity: min. 98%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: MUS RATTUS, Brunnthal
- Weight at study initiation: 185 +/- 15g
- Housing: routinely 3 animals/cage.
- Diet: complete diet ad libitum
- Water: tap water ad libitum


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

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: steel-glass whole body inhalation chamber
- Exposure chamber volume: 200 L
- Method of holding animals in test chamber: groups of 5 animals in wire mesh cages were exposed
- System of generating test atmospheres: a pump delivered test substance at constant rates to a glass evaporator heated to 40-70°C.
The vapor was diluted with fresh air before it entered the exposure chamber.
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data


TEST ATMOSPHERE
- Brief description of analytical method used: air was abstracted with a tube at a rate of 5.4 L/min from the exposure chamber and guided through an IR photometer and then back to the inhalation chamber.
- Samples taken from breathing zone: yes



TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not determined
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not determined


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
analytical concentration according to amendment (BASF SE 2014): 3.38, 7.29, 8.37, 11.1, 14.7 mg/l
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs: Symptoms were observed during exposure and daily during the observation period.
Body weights were determined the day before treatment and weekly thereafter.
- Necropsy of survivors performed: yes
Statistics:
Probit analysis according to Finney

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
7.85 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
There were no mortalities (0/20 exposed animals) at 3.38 mg/L. Mortality increased rapidly between 7.29 and 8.37 mg/L, and complete mortality was seen at 11.1 mg/L and above. All concentrations mentioned represent analytical results. The combined LC50 for male and female rats was 7.85 mg/L.
Clinical signs:
other: Closed lids, snout swiping, discharge from nose and eye, corrosion of nose and eyes, salivation, corneal opacity, loss of pain reflex, dyspnea, respiration sounds, flatulence, apathy, hunched posture, unsteady gait were seen in all treated groups. Symptom
Body weight:
Body weights were dose-dependently depressed in all survivors on day 7. Body weight gain was noted in the second week after treatment. The group at 8.37 mg/l did not reach the initial weight.
Gross pathology:
Dead animals: heart dilatation, hyperemic; lung: inflated.
Sacrificed animals: no findings.

Any other information on results incl. tables

Mortality

There were no mortalities (0/20 exposed animals) at 3.38 mg/L. Mortality increased rapidly between 7.29 and 8.37 mg/L, and complete mortality was seen at 11.1 mg/L and above. 

 

Dose  

(mg/L; analytical)

 

mortalities/animals exposed

males

females

3.38

0/10

0/10

7.29

2/10

1/10

8.37

8/10

8/10

11.1

10/10

10/10

14.70

10/10

10/10

 

The combined LC50 for male and female rats was 7.85 mg/L.

 

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:

The clinical signs indicated corrosive properties of the test substance, evidenced by the occurrence of corneal opacity and corrosion of the dorsal nose in some cases. The symptoms persisted until termination 14 days after the rats were exposed to 7.29 mg/l or above. There were no changes in animals that survived. Inflated lungs and dilated hearts were seen in animals that died.
Executive summary:

Conclusion

The LC50 (4h) was 7.85 mg/l in male and female rats. The clinical signs indicated corrosive properties of the test substance, evidenced by the occurrence of corneal opacity and corrosion of the dorsal nose in some cases. The symptoms persisted until termination 14 days after the rats were

exposed to 7.29 mg/l or above.

There were no changes in animals that survived. Inflated lungs and dilated hearts were seen in animals that died.