Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 403 & GLP. Test substance is micronized from this substance. The commercial product (>355 um) has practically no micronized particle size (<10 um .Test substance is micronized from this substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity:>99.9%
Test substance is micronized from this substance.
The commertial product (>355 um) has practically no micronized particle size (<10 um .

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: atomise the aceton/water (80/20) solution
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
0.009, 0.016, 0.033, 0.033, 0.044, 0.183 mg/l
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
0.034 mg/L air
95% CL:
> 0.031 - < 0.037
Exp. duration:
4 h
Mortality:
Conc (mg/L) M F Total
0.009 0/5 0/5 0/10
0.016 0/5 0/5 0/10
0.033 4/5 1/5 5/10
0.044 4/5 4/5 8/10
0.183 5/5 5/5 10/10
Clinical signs:
other: The signs seen during exposure were considered to be partial closing of the eyes, adoption of a hunched body posture, opening of the mouth during inspiration and exaggerated respiratory movement.
Body weight:
There were moderate to marked decreases of bodyweight or reductions in the rate of bodyweight gain for up to 7 days following exposure to this test substance.
Gross pathology:
The findings for rats that died as a result of exposure to this test substance were typified by congestion of the lungs and/or distension of the gastro-intestinal tract. The latter is commonly seen in rats that die as a result of respiratory difficulties and is due to swallowing of air during attempts to breathe.
Other findings:
Other findings were considered to be within the normal background ranges, and of no toxicological importance.
There were no clear evidence of a sex difference in mortaity due to inhalation of this test substance.

Any other information on results incl. tables

Conc. Date of death (M/F)

 Conc. mg/L  0 h  1h 4 h 1 d  2 d  8 d  14 d 
 0.033  0/0  0/0 0/0  4/1  4/1  4/1  4/1 
 0.044  0/0 0/0  1/0  4/3  4/3  4/4  4/4 
 0.183  0/0 2/1  2/4  5/5  5/5  5/5  5/5 

Applicant's summary and conclusion

Interpretation of results:
other: This data is not effective to this product due to this product particle is not micronised.
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
LC = 0.034 mg/L. Test substance is micronized from this substance. The results show that on average, approximately 80% of the PMI present in the chamber
atomosphere was in the form of particle of respirable size (< 5.5 um aerodynamic diameter).
The commertial product (>295 um) has practically no micronized particle size (<10 um) .
Executive summary:

In an acute inhalation toxicity study, groups of young adult albino rats (Sprague-Dawley origin) , 5/sex were exposed by inhalation route to PMI (>99.5% provided by NIPPON SHOKUBAI 7Y09) in acetone/water (80/20) for 4 hours to whole body at concentrations of  0, 0.009, 0.016, 0.033, 0.044, 0.183 mg/L.  Animals then were observed for 14 days.

 

LC50 Combined = 0.034 mg/L (standard error : 0.0033 mg/L)   

PMI is classified as the category 1 in accordance with GHS for acute inhalation toxicity study.

The commertial product (>295 um) has not including any respirable fraction, practically the rsik by inahalation is very low .

However, we should consider the DNEL for inhalation for workers because of any accidental release of this product at polymer manufacturers plant site.