Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401). 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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limited study design details in the report, no details on environmental conditions: not expected to affect the outcome of the study
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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: Charles River strain (COBS)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. , North Wilmington, Massachusetts
- Age at study initiation: no data
- Weight at study initiation: 150 to 198 g
- Fasting period before study: 16 hours
- Housing: Housed in stock cages. Following oral administration of the test material, the rats were housed individually in observation cages.
- Diet: free access to standard laboratory rat diet (Purina Rat Chow)
- Water: free access to water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:
other: oral, using a hypodermic syringe equipped with a ballpointed intubating needle.
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Rats were intubated with previously calculated doses of the undiluted test material.
Doses:
1400, 2000, 3000 and 4600 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights: At day 0 and day 14. Mortalities and/or reactions observed were recorded during the observation period of 14 days.
- Necropsy of survivors performed: yes
Statistics:
LD50 calculated using the techniques of Weil, Thompson, and Thompson and Weil.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 600 mg/kg bw
Based on:
test mat.
Mortality:
1400 mg/kg: no mortality
2000 mg/kg: 3 animals died
3000 mg/kg: 6 animals died (3 males, 3 females)
4600 mg/kg: all animals were found dead
Clinical signs:
Hyperpnea, hypoactivity, ruffed fur, tremors, dyspnea, muscular weakness, clonic convulsions (intermittent) and emaciation (highest dose only) were observed during the observation period.
Body weight:
Normal (group 1400 and 2000 mg/kg bw)
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:
Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with DPM 3-800LC with male and female rats, performed equivalent to OECD 401 guideline, an LD50 of 2600 mg/kg bw was calculated.
Executive summary:

The test substance DPM 3 -800LC was tested in an acute oral toxicity study with male and female rats, performed equivalent to OECD 401 guideline. Deaths occured at the 2000, 3000 and 4600 mg/kg dose levels. Hyperpnea, hypoactivity, ruffed fur, tremors, dyspnea, muscular weakness, clonic convulsions (intermittent) and emaciation were observed during the observation period. No effect on body weight was observed.

Based on the results, an LD50 of 2600 mg/kg bodyweight was calculated.