Reaction product of alkylarylsulphonic acid and cycloaliphatic amine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1978

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Version / remarks:

Acute Inhalation Study. FHSLA, CFR, Title 21, para. 191.10

Deviations:

yes

Principles of method if other than guideline:

the main deviation is the exposure duration of 1 h. In addition no information on body weight gain is provided.

GLP compliance:

no

Test type:

traditional method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Details on test material:

43% in water/(iso)propanol

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Weight at study initiation: Males 255-280 g; females 237-261 9
- Fasting period before study: NA
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Remark on MMAD/GSD:

no data

Details on inhalation exposure:

exposure to vaporized substance

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Remarks on duration:

deviation from the guideline

Concentrations:

22 mg/L

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 22 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

1 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 9.5 mg/L air

Based on:

act. ingr.

Exp. duration:

1 h

Remarks on result:

other: corrected for purity based on a density of 1 mg/cm3

Mortality:

1 male died on day 6

Clinical signs:

other: none reported

Body weight:

no data on body weight gain

Gross pathology:

pulmonary congestion in animal that died

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

No definite conclusion can be drawn.

Executive summary:

Five rats/sex were exposed to the substance during 1 hour at 22 mg/L(nominal). One animal died, showing pulmonary congestion. No toxic effects were seen in the other animals. The LC50 is > 9.5 mg/L (corrected for purity).