Registration Dossier
Registration Dossier
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EC number: 204-781-0 | CAS number: 126-30-7
Repeated dose toxicity: inhalation
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:
- 1 963
- 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:
- 1 983
- Bibliographic source:
- Eastman Kodak thechnical data sheet
- Reference Type:
- publication
- Title:
- Information profiles on potential occupational Hazards: Glycols
- Author:
- NIOSH
- Year:
- 1 982
- 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 substance name:
- Reference substance 001
- Details on test material:
- no further details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system 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.
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