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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to basic scientific principles.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
specific investigations: other studies
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to basic scientific principles.
Reason / purpose:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were exposed for 4 h/day, for 4 consecutive days and the upper airway was examined.
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
respiratory irritation
Species:
rat
Strain:
other: CDI
Sex:
female
Details on test animals and environmental conditions:
Two groups of 6 female CDI rats (Charles River U.K. Ltd.), weighing between 150 and 200 g, were randomly selected from a batch of 24 animals on arrival at the laboratory. Animals, caged in groups of 3 in plastic grid-bottomed cages were housed in a temperature controlled room (21-24°C: and allowed unlimited access to pelletted laboratory diet (Labsure PRD) and mains tap water. The animals were acclimatized to the laboratory for 5 days prior to the start of the study.
Route of administration:
inhalation: vapour
Vehicle:
unchanged (no vehicle)
Details on exposure:
head only exposure
Executive summary:

Exposure of rats to atmospheres containing an average of 214 mg/m3, 4 h/day, for 4 consecutive days resulted in irritation of the membranes lining the upper respiratory tract but only minimal signs of lung injury. Histopathological changes were observed in the nasal cavity, trachea and larynx and included loss of cilia, mucous and basal cell hyperplasia and squamous metaplasia.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were exposed for 4 h/day, for 4 consecutive days and the upper airway was examined.
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
respiratory irritation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The white spirit used for this study was a commercial-grade solvent which consisted of approx. 61% paraffins, 20% naphthenes and 19% aromatics. The mixture contained mainly C9-C12 hydrocarbons and its boiling point range was l50-l95°C.

Test animals

Species:
rat
Strain:
other: CDI
Sex:
female
Details on test animals and environmental conditions:
Two groups of 6 female CDI rats (Charles River U.K. Ltd.), weighing between 150 and 200 g, were randomly selected from a batch of 24 animals on arrival at the laboratory. Animals, caged in groups of 3 in plastic grid-bottomed cages were housed in a temperature controlled room (21-24°C: and allowed unlimited access to pelletted laboratory diet (Labsure PRD) and mains tap water. The animals were acclimatized to the laboratory for 5 days prior to the start of the study.

Administration / exposure

Route of administration:
inhalation: vapour
Vehicle:
unchanged (no vehicle)
Details on exposure:
head only exposure

Results and discussion

Applicant's summary and conclusion

Executive summary:

Exposure of rats to atmospheres containing an average of 214 mg/m3, 4 h/day, for 4 consecutive days resulted in irritation of the membranes lining the upper respiratory tract but only minimal signs of lung injury. Histopathological changes were observed in the nasal cavity, trachea and larynx and included loss of cilia, mucous and basal cell hyperplasia and squamous metaplasia.