Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 403). Non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
no details on environmental conditions, no analytical data on the maximum attainable concentration.
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
EC Number:
701-196-7
Cas Number:
72244-98-5
Molecular formula:
not applicable
IUPAC Name:
Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): DION® Polymercaptan Resin DPM 3-800LC
- Description: viscous, amber liquid

Test animals

Species:
rat
Strain:
other: albino Charles River strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 200 g (average)
- Housing: individually in stock cages
- Diet: free access to standard laboratory diet (Purina Rat Chow)
- Water: free access to water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Vapor generator
- Exposure chamber volume: 70 L
- Method of holding animals in test chamber: Each animal was caged separately
- Source and rate of air: 4.0 L/min
- Temperature, humidity, pressure in air chamber: 26°C and the pressure was 29. 79 inches Hg

TEST ATMOSPHERE
- Brief description of analytical method used: no data
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:
not specified
Remarks:
Average nominal vapor concentration was calculated by dividing the generator weight loss by the total volume of air used during the test.
Duration of exposure:
4 h
Concentrations:
0.1 mg/L (nominal), 99% of maximum vapor concentration was established.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weights were determined prior to inhalation exposure and for each surviving animal at the end of the 14-day observation period.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.1 mg/L air (nominal)
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: No data.
Body weight:
No adverse effects were observed (results not included).
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to Regulation (EC) No 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute inhalation toxicity study with male and female rats, performed equivalent to OECD 403 guideline, an LC50 > 0.1 mg/L air was determined.
Executive summary:

The test substance DPM 3 -800LC was tested in an acute inhalation toxicity study with male and female rats, performed equivalent to OECD 403 guideline. Concentration of 0.1 mg/L (nominal), 99% of maximum vapor concentration was established. No deaths occurred. At gross pathology no abnormalities were observed.

Based on the results, an LC50 > 0.1 mg/L air was determined.