Registration Dossier

Administrative data

Endpoint:
chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
The study was published in 1958
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The acute toxicity of this compound was assessed as part of a larger study on the toxicity of epoxy resins

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1958

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Groups of rats were exposed for seven hours, five days a week for a total of 50 exposures, with air saturated with diglycidyl resorcinol.
GLP compliance:
no
Limit test:
no

Test material

Specific details on test material used for the study:
Diglycidyl resorcinol; no other details reported

Test animals

Species:
rat
Strain:
Long-Evans
Details on species / strain selection:
Male rats: 80 - 104 g body weight. No other details
Sex:
male
Details on test animals and environmental conditions:
No details specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks on MMAD:
No details reported
Details on inhalation exposure:
Groups of 10 male rats (80-104g) were exposed five days a week for seven hours, for a total of 50 exposures, to air saturated with the vapor of diglycidyl resorcinol. Similalrly one group of 10 control rats was exposed to uncontaminated air. The animals were exposed in cylindrical steel chambers of 210-litres capacity at 20±1”C.
Air was substantially saturated with DGR by passage through one fritted glass bubbler following warming in a heating jacket to reduce the viscosity. The air flow was held constant at 15 liters per minute. A preliminary saturation period of about an hour insured greater than 95% saturation of the air prior to exposure of the animals. No analytical check was made of the concentration, since it was too low to permit accuracy of the determination.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
Five days a week for seven hours, for a total of 50 exposures
Frequency of treatment:
daily
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Details on study design:
Groups of 10 male rats (80-104g) were exposed five days a week for seven hours, for a total of 50 exposures, to air saturated with the vapor of diglycidyl resorcinol. Similarly one group of 10 control rats was exposed to uncontaminated air. The animals were exposed in cylindrical steel chambers of 210-litres capacity at 20±1”C.
Air was substantially saturated with DGR by passage through one fritted glass bubbler following warming in a heating jacket to reduce the viscosity. The air flow was held constant at 15 liters per minute. A preliminary saturation period of about an hour insured greater than 95% saturation of the air prior to exposure of the animals. No analytical check was made of the concentration, since it was too low to permit accuracy of the determination.

The rats were observed for signs of intoxication during and after each exposure. Individual weights were recorded, and mean weight changes were graphed in the form of growth curves. At the end of the experimental period, the rats were decapitated under light ether anaesthesia, exanguinated, and examined for gross changes. Representative tissues were taken for histologic study, and the organ/body weight ratios were determined on liver, lungs, and kidneys for statistical analysis.
Positive control:
no

Examinations

Observations and examinations performed and frequency:
The rats were observed for signs of intoxication during and after each exposure. Individual weights were recorded, and mean weight changes were graphed in the form of growth curves. At the end of the experimental period, the rats were decapitated under light ether anaesthesia, exanguinated, and examined for gross changes. Representative tissues were taken for histologic study, and the organ/body weight ratios were determined on liver, lungs, and kidneys for statistical analysis.
Sacrifice and pathology:
At the end of the experimental period, the rats were decapitated under light ether anaesthesia, exanguinated, and examined for gross changes. Representative tissues were taken for histologic study, and the organ/body weight ratios were determined on liver, lungs, and kidneys for statistical analysis.

Results and discussion

Results of examinations

Clinical signs:
effects observed, non-treatment-related
Description (incidence and severity):
The series of 50 exposures to the saturated vapours of DGR was free from untoward effects. Aside form a very slight incrustation of the eye-lids of some animals, with red-brown exudate, none of the rats showed any signs of toxicity or irritation attributable to the exposure.
Mortality:
mortality observed, non-treatment-related
Description (incidence):
One rat in the treated group and two in the control group died between the third and fourth weeks. At necropsy these animals were found to have bronchial pneumonia
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Analysis of variance showed no significant difference in mean weight gains or in organ/body weight ratios (p= <0.05).
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
Analysis of variance showed no significant difference in mean weight gains or in organ/body weight ratios (p= <0.05).
Gross pathological findings:
no effects observed
Description (incidence and severity):
No significant gross or macroscopic lesions were found in the surviving animals
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Other effects:
not specified

Applicant's summary and conclusion

Conclusions:
No systemic toxicity has resulted from inhalation to the air saturated vapors of diglycidyl resorcinol.
Executive summary:

The inhalation toxicity of diglycidyl resorciol was examined as part of a study into the toxicity of epoxy resins. Although well described the published data lacks any detailed analysis of the results. There was no analytical data to support the study or to allow effect levels to be determined.

The overall conclusion of the inhalation toxicity described in this study was that no systemic toxicity resulting from the inhalation to the air saturated vapours of diglycidyl resorcinol was seen.