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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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
May 1981
Deviations:
yes
Remarks:
Only one concentration tested which does not permit the determination of an LC50.
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Version / remarks:
April 1984
Deviations:
yes
Remarks:
Only one concentration tested which does not permit the determination of an LC50.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Version / remarks:
November 1984
Deviations:
yes
Remarks:
Only one concentration tested which does not permit the determination of an LC50.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexylamine
EC Number:
203-233-8
EC Name:
2-ethylhexylamine
Cas Number:
104-75-6
Molecular formula:
C8H19N
IUPAC Name:
2-ethylhexylamine
Specific details on test material used for the study:
- Lot/batch No.: IRAA 005

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: 8-12 weeks
- Weight at study initiation: male: 194 - 204 g; female: 196 - 201 g
- Housing: 5 animals per cage
- Diet: Rattendiaet Altrornin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 60 L
- Temperature, humidity in air chamber: 22.5 - 23.4 °C; 19.7 - 32.8 %

Analytical verification of test atmosphere concentrations:
yes
Remarks:
FID-gaschromatography
Duration of exposure:
4 h
Concentrations:
1.548 mg/L (analytical)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
< 1.548 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
All rats died within 40 - 177 minutes after the start of exposure.
Clinical signs:
other: Exposed animals showed impairment of respiration, salivation, nasal discharge and periodically arising tonic spasms. Although tonic spasms were reported as clinical signs, these spasms were only seen in moribund animals that died shortly thereafter. Thus,
Body weight:
no data
Gross pathology:
At necropsy, macroscopic dark red spots were found on the lungs, and when the lungs were opened small quantities of white foam were detected.

Any other information on results incl. tables

The LC50 for 2-ethylhexylamine is below 1.548 mg/L air (4 h exposure). A precise evaluation of the LC50 was not performed.

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria