Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: test data from ELINCS-notification obtained from ECHA on 10-June-2010 (EC-no. 405-740-1 / notification-no. 91-06-0255-00); performed under GLP and according to EU-testing methods
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
A limit concentration of 2.6 mg/l was used because the results of the acute oral test suggested to the test laboratory that all animals would die if exposed to 5 mg/l.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
no data

Test animals

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

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
other: snout only
Vehicle:
air
Details on inhalation exposure:
Mass median aerodynamic diameter (for liq.+solid aerosol):
Mass mean aerodynamic diameter 6.2 mcrometers; 25.5% of droplets were less than 3.5 micrometers in diameter
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
A limit concentration of 2.6 mg/l was used because the results of the acute oral test suggested to the test laboratory that all animals would die if exposed to 5 mg/l.
No. of animals per sex per dose:
5 animals per sex and dose group.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.6 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
Males: 2.6 mg/L; number of animals: 5; Number of deaths: 0
Females: 2.6 mg/L; number of animals: 5; Number of deaths: 0
Clinical signs:
other: In all animals there was no response to audio/physical stimuli on day 1, and abnormal respiration (very severe up to day 3), subdued behaviour and umkempt appearance until day 8-11. The severe respiratory effects noted post exposure included gasping, crac
Body weight:
Weight loss (by up to 30%) occurred in all animals during day 1 to 4.
Gross pathology:
Pale colouration of lungs was reported in 4/10 animals.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tle combined acute inhalative LC50 on rats was determined to be > 2.6 mg/L air.
Executive summary:

This LC50 study was performed following a modified Annex V limit test. A limit concentration of 2.6 mg/l was used because the results of the acute oral test suggested to the test laboratory that all animals would die if exposed to 5 mg/l. The marked weight loss and severe respiratory effects noted at 2.6 mg/l supported this prediction. Sprague-Dawley rats were used in this test, test item was applied as liquid aerosol to snout only. No mortaslity was noted besides of the clinical signs mentioned above. Gross pathology showed pale discoloration of the lungs in 4 out of ten animals.

Based on these findings, the substance is classified as Harmful / Acute Tox. IV.