3-chlorophenyl isocyanate

Respiratory sensitisation

Administrative data

Endpoint:

respiratory sensitisation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No OECD Guideline defined.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Principles of method if other than guideline:

8 female guinea pigs/ group were induced 3 times intradermal with the test substance (application in peanut oil on day 0- 5%, day 2- 2% and day 4- 2%, in each case 100 µl, twice). The control animals received the vehicle peanut oil under identical test conditions. After a 2-weeks observation period (day 21 to day 24) a test substance challenge was performed (medium concentration: ca. 0.7 mg test substance/m³ air). During and after each challenge-exposition (ca. 30 minutes duration) reactions of the direct-type wer measured in all animals by measuring the breathing-frequency, the breathing-volume, the breathing-minute-volume, the inspiration and the expiration-time and the Peak Expiratory Flow.
Thereafter the measurement of the breathing-frequency in appriximately 20 minutes took place, in order to observ also delayed reactions. At the end of the observation period all guinea pigs were killed and the weight of the blood-free lung was determined. Lung and trachea were examined histologically.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Purity: 99.8 %; Molecular weight: 153.6 g/mol

Test animals

Species:

guinea pig

Strain:

other: BOR:PDH

Sex:

female

Test system

Route of induction exposure:

intradermal

Route of challenge exposure:

inhalation

Vehicle:

peanut oil

Concentration:

Application in peanut oil on day 0- 5%, day 2- 2% and day 4- 2%

No. of animals per dose:

8

Results and discussion

Results:

After the test substance challenge no specific breathing reaction was observed, which could lead to a lung sensitizing potential of the test substance.
Several animals of both groups showed marginal changes of the breathing parameters, however these parameters were not in coherence to the primary irritation potential of the test substance. No evidence of diminuated breathing reactions were observed.
The analysis of Lung weights showed no statistic signifficant increase of the absolute or relative lungweight in the test substance group.
The histopathological examinations of trachea and lung showed no statistical signifficant increase of eosinophil granulocytes in the submucosa of the bronchia in comparison to the vehicle control group.
No toxicological important reactions, due to immunulogical reactions could be seen. The substance therefore is not found to be sensitizing to the lung.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Executive summary:

In a lung sensitizing study 8 female guinea pigs/ group were induced 3 times intradermal with the test substance (application in peanut oil on day 0- 5%, day 2- 2% and day 4- 2%, in each case 100 µl, twice). The control animals received the vehicle peanut oil under identical test conditions. After a 2-weeks observation period (day 21 to day 24) a test substance challenge was performed (medium concentration: ca. 0.7 mg test substance/m³ air). During and after each challenge-exposition (ca. 30 minutes duration) reactions of the direct-type wer measured in all animals by measuring the breathing-frequency, the breathing-volume, the breathing-minute-volume, the inspiration and the expiration-time and the Peak Expiratory Flow. Thereafter the measurement of the breathing-frequency in appriximately 20 minutes took place, in order to observ also delayed reactions. At the end of the observation period all guinea pigs were killed and the weight of the blood-free lung was determined. Lung and trachea were examined histologically.

After the test substance challenge no specific breathing reaction was observed, which could lead to a lung sensitizing potential of the test substance. Several animals of both groups showed marginal changes of the breathing parameters, however these parameters were not in coherence to the primary irritation potential of the test substance. No evidence of diminuated breathing reactions were observed. The analysis of Lung weights showed no statistic signifficant increase of the absolute or relative lungweight in the test substance group. The histopathological examinations of trachea and lung showed no statistical signifficant increase of eosinophil granulocytes in the submucosa of the bronchia in comparison to the vehicle control group. No toxicological important reactions, due to immunulogical reactions could be seen. The substance therefore is not found to be sensitizing to the lung.