Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
1-h inhalation study with GDMA mist
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of study
Test type:
traditional method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene di(S-thioacetate)
EC Number:
204-653-4
EC Name:
Ethylene di(S-thioacetate)
Cas Number:
123-81-9
Molecular formula:
C6H10O4S2
IUPAC Name:
2-[(2-sulfanylacetyl)oxy]ethyl 2-sulfanylacetate
Specific details on test material used for the study:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
inhalation: mist
Type of inhalation exposure:
whole body
Vehicle:
air
Remark on MMAD/GSD:
not reported
Details on inhalation exposure:
Total weight of compound used: 2.7 g
Air flow rate: 20 L/min
Duration: 60 min
Total air: 1200 L
Nominal conc.: 2.25 mg/L
Avg. chamber temperature: 20 °C
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.25 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.563 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: calculated using Haber's law
Mortality:
none
Clinical signs:
other: decreased activity, laboured breathing, lacrimation, nasal discharge
Body weight:
no effect
Gross pathology:
9/10 lungs showed few scattered red or grey foci

Applicant's summary and conclusion

Interpretation of results:
other: H335: May cause respiratory irritation.
Conclusions:
With an estimated 4-h LC50 of >0.563 mg/L, GDMA may be classified as Acute Tox 3, H331: Toxic if inhaled. As no animal died in the study, the classification as toxic would not be appropriate. Because the animals showed symptoms of irritation of the lungs, H335: May cause respiratory irritation was used instead of H331: Toxic if inhaled.