Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: No reliability; short communication without details, one dose level, only 3 rats, no controls, variance in exposure concentration.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963
Reference Type:
publication
Title:
Product information on glycols, NPG (neopentyl glycol; 2,2-dimethyl-l,3-propanediol)
Author:
Eastman Kodak Chemicals
Year:
1983
Bibliographic source:
Eastman Kodak thechnical data sheet
Reference Type:
publication
Title:
Information profiles on potential occupational Hazards: Glycols
Author:
NIOSH
Year:
1982
Bibliographic source:
PB 89-215776

Materials and methods

Principles of method if other than guideline:
Toxic effects in rats after inhalation exposure to 4000 ppm, 6 h/day for 10 days.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no further details

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
other: presumably whole body
Vehicle:
other: air
Remarks on MMAD:
MMAD / GSD: not applicable
Details on inhalation exposure:
Test substance heated in a two-neck flask to 180-192°C; air flow 1 L/min; temperature in the chamber 26°C
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
10 d
Frequency of treatment:
6 h/d
Doses / concentrations
Remarks:
Doses / Concentrations:
mean concentration 4000 ppm (17 mg/L); range: 7.7-57.5 mg/L
Basis:
no data
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
post exposure observation period 4 days
Positive control:
no

Examinations

Observations and examinations performed and frequency:
clinical signs and mortality
Sacrifice and pathology:
no data in the original study report but in secondary literature
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Gross pathological findings:
no effects observed
Details on results:
Data from study report:
"Nose rubbing in 15 min. Vasodilation, extremities are pink in 15 min. Accelerated resp. in 45 min. & in 2 h 45 min.
Roughing of hair in 3 hrs. 55 min.
Rats hair became yellow in color on the first exposure & continued to remain yellow throughout the exposures and at the 14 day WT"
Increase in body weight (average 62.3 g.)
Necropsy: No evidence was found of toxic effects on internal organs (data from secondary literature).

Effect levels

Dose descriptor:
other: dose level inducing clinical signs
Effect level:
4 000 ppm
Sex:
not specified
Basis for effect level:
other: only one concentration tested in 3 rats

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No further details available.

Applicant's summary and conclusion

Conclusions:
Clinical signs but no mortality were reported after daily exposure of 3 rats for 6 h to 4000 ppm for 10 consecutive days.
Executive summary:

No reliability; short communication without details, one dose level, only 3 rats, no controls, variance in exposure concentration.

Three rats were exposed to vapour at 4000 ppm for 6 hours a day for ten days. Symptoms of irritation of the respiratory tract and dilatation of the skin blood vessels were detected. At necropsy no evidence was found of toxic effects on internal organs.

Conclusion: Clinical signs but no mortality were reported after daily exposure of 3 rats for 6 h to 4000 ppm for 10 consecutive days.