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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:
disregarded due to major methodological deficiencies
Study period:
10/07/78 to 24/07/78
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
Reference from study report: OECD Guideline for Testing of Chemicals, 1981
GLP compliance:
not specified
Test type:
concentration x time method

Test material

Constituent 1
Chemical structure
Reference substance name:
N-cyclohexyl-N-methylcyclohexylamine
EC Number:
231-453-4
EC Name:
N-cyclohexyl-N-methylcyclohexylamine
Cas Number:
7560-83-0
Molecular formula:
C13H25N
IUPAC Name:
N-cyclohexyl-N-methylcyclohexanamine
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
ABBOTT-32512 (POLYCAT 12); lot numbers 79-500-CJ and 71-819-AK
Chemical Division, Abbott Laboratories

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test material was placed in a 500 ml gas washing bottle. Dry air, at the minimum chamber flow of 4 liters per minute, was passed through the test material. The resulting vapors were directed into a 26.5 liter glass exposure chamber housing the test animals.

OTHER SPECIFICS:
a clear colorless liquid
flash point 214°F (101°C)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts
- Microbiological status of animals, when known:
The animals were observed prior to the exposure to insure that they were free of abnormal signs.
- Age at study initiation: not specified
- Weight at study initiation: 205-270 g

- Housing: a 26.5 liter glass exposure chamber housing the test animals
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 26.0°C to 29.5°C (chamber temperature during the exposure period)
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Date of exposure: July 10, 1978
Date of terminal sacrifice: July 24, 1978

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The vapor was generated by bubbling clean dry air through the test material in a gas washing bottle.
- Exposure chamber volume: a 26.5 liter glass exposure chamber housing the test animals
- Source and rate of air: 4 l/min
- System of generating particulates/aerosols:
The test material was placed in a 500 ml gas washing bottle. Dry air, at the minimum chamber flow of 4 liters per minute, was passed through the test material.
- Temperature, humidity, pressure in air chamber:
The chamber temperature during the exposure period ranged from 26.0°C to 29.5°C.

TEST ATMOSPHERE
- Brief description of analytical method used:
The flask containing the test material was weighed before and after the exposure period to determine the nominal exposure concentration.
During the exposure a total of 0.13 grams of test material was delivered in a total volume of 240 litres of air, yielding a nominal exposure concentration of 0.54 mg/L.
- Samples taken from breathing zone: no

VEHICLE
- Concentration of test material in vehicle (if applicable): a nominal concentration of 0.54 mg/l of air-vapor mixture

Analytical verification of test atmosphere concentrations:
no
Remarks:
/ The flask containing the test material was weighed before and after the exposure period to determine the nominal exposure concentration.
Duration of exposure:
1 h
Concentrations:
nominal 0.54 mg/L of Polycat 12
No. of animals per sex per dose:
5 male/5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were measured on days 0 (prior to exposure) 1, 2, 4, 7 and 14.
Animals were observed prior to exposure, at 15-minute intervals during exposure, hourly for four hours postexposure and then daily for 14 days.

- Necropsy of survivors performed: on day 14 all animals were sacrificed (ethylether) and subjected to gross necropsy examinations.

Results and discussion

Effect levels
Key result
Sex:
male/female
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
None
Clinical signs:
other: No changes during exposure. Sporadic occurrences of salivation, nasal discharge, rales, soft stools or lacrimation during four-hour period immediately following exposure and 14-day observation period.
Body weight:
Small, transient decrease in body weight in 4/10 rats during first two days post-exposure.
Gross pathology:
Lung discoloration in 5/10 rats at necropsy.

Applicant's summary and conclusion

Conclusions:
A one-hour inhalation exposure to vapors of Polycat 12, at a nominal concentration of 0.54 mg/L, did not produce mortality or definitive signs of toxicity in the exposed Sprague-Dawley rats.
Executive summary:

RESULTS AND DISCUSSION

During the exposure a total of 0.13 grams of test material was delivered in a total volume of 240 litres of air, yielding a nominal exposure concentration of 0.54 mg/L.

During the exposure period no abnormal signs were observed.

Upon removal from the chamber slight excessive salivation was observed in 3 animals.This sign had abated by the four-hour post-exposure observations and the only other observations recorded during the four-hour post-exposure period were mucoid nasal discharge (1 of 10 rats) and dry rales (1 of 10 rats) recorded at one hour post-exposure.

During the 14-day in-life period dry rales was observed in eight of ten animals. Occurrence of this sign was generally scattered throughout the 14-day period. Scattered incidences of mucoid nasal discharge (3 of 10 rats) were also recorded. The only other observations during this period were soft stool in two animals (one observation each) and excessive lacrimation in one animal (one observation). None of these in-life observations were considered unusual for Sprague-Dawley rats in exposures of this type.

Individual body weights were considered normal and are presented along with necropsy observations in Table 1. Necropsy examination revealed lung discoloration in five of ten animals.