Registration Dossier

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
n/a
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Studies were conducted according to basic scientific principles. This record is a summary of those studies.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Petroleum hydrocarbon toxicity studies. III. Animal and human response to vapors of Stoddard solvent.
Author:
Carpenter, C., Kinkead, E., Geary, D., Sullivan, L, and King, J.
Year:
1975
Bibliographic source:
Toxicology and Applied Pharmacology 32:282-297.
Reference Type:
publication
Title:
Model studies for evaluating the neurobehavioral effects of complex hydrocarbon solvents. II. Neurobehavioral effects of white spirit in rat and human.
Author:
Lammers, J, Emmen, H., Muijser, H., Hoogendijk, E., McKee, R., Owen, D., and Kulig, B.
Year:
2007
Bibliographic source:
Neurotoxicology 28:736-750.
Reference Type:
publication
Title:
Response of the upper respiratory tract of the rat to white spirit vapour.
Author:
Riley, A., Collings, A., Browne, N., and Grasso, P.
Year:
1984
Bibliographic source:
Toxicology Letters 22:125-131.
Reference Type:
publication
Title:
Petroleum hydrocarbon toxicity studies I. Methodology.
Author:
Carpenter, C., Kinkead, E., Geary, D., Sullivan, L., and King, J.
Year:
1975
Bibliographic source:
Toxicology and Applied Pharmacology 32:246-262.
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
publication
Title:
Irritating properties of airborne materials to the upper respiratory tract
Author:
Alarie, Y.
Year:
1966
Bibliographic source:
Archives of Environmental Health 13:433-449.

Materials and methods

Endpoint addressed:
respiratory irritation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Executive summary:

Respiratory Irritation

 

There are no reports of respiratory irritation in humans associated with exposure to C9-C14 aliphatic solvents. Two studies have been reported in which volunteers were exposed to C9-C14 aliphatic solvents at differing concentrations. In the first of these, 6 volunteers were exposed for 15 minutes at levels ranging from 24-470 ppm (126-2468 mg/m3) and, after exposure, asked to report their symptoms. There were no reports of throat irritation at the two lower concentrations and only one of the 6 reported throat irritation at the highest level (Carpenter et al., 1975). In the second (Lammers et al., 2007), 12 volunteers were exposed for 4 hours to C9-C14 aliphatic solvents at levels of either 57 or 570 mg/m3. There was no evidence of respiratory irritation that could be associated with exposure; of the 12 volunteers, none reported 'dry throat' at either level, and only one at each level reported mild coughing. 

 

In animal studies, Riley et al. (1984) reported that repeated exposure of rats (4h/day, 4 consecutive days) to white spirit at 214 mg/m3 produced histological changes in the nasal cavity, trachea, and larynx. These are described as loss of cilia, mucous and basal cell hyperplasia and squamous metaplasia. On the other hand, similar effects were not reported in longer term studies at higher levels. As one example, Carpenter et al. (1975a) exposed rats and dogs for 13 weeks. As described in a separate publication (Carpenter et al., 1975b) exposures were 5h/day, 5 days/week for 13 weeks. The analytically determined exposure levels were 480, 1100 and 1900 mg/m3. The pathological investigation of rats did not reveal treatment related lesions in lung or trachea. The investigation of the respiratory tract in dogs was more thorough and, in addition to lungs and trachea, also included tracheal bifurcation, pharynx, tonsil and nasal mucosa. However, as in the rat study, no treatment related effects in the respiratory tract were reported. Similarly, two other repeated exposure studies in rats involving either 12 or 13 weeks (ExxonMobil Biomedical Sciences, Inc., 1979; Shell 1979) also reported no unusual findings in the respiratory tract. Finally, there have also been two studies of upper airway sensory irritation in mice using the methodology developed by Alarie (1966). In the first of these studies (Carpenter et al., 1975a), a 50% depression in respiratory rate was observed in mice exposed to 10,000 mg/m3 (1700 ppm), but not at 4.4 mg/l (770 ppm). In the second of these studies (ExxonMobil Biomedical Sciences, Inc., 1988), a maximum exposure concentration of 170 ppm (935 mg/m3) produced a respiratory depression of 15%, a response which was considered to be slightly irritating. 

 

Taken as a whole, the animal data suggest that C9-C14 aliphatic solvents are not highly irritating to the respiratory tract and certainly not at occupational levels. The results of the volunteer studies also provide no indication that C9-C14 aliphatic solvents are respiratory irritants.