Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 402). 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 402 (Acute Dermal 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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: Individually in hanging rabbit cages
- Diet: Free access to standard laboratory rabbit ration (Purina Rabbit Chow Checkers)
- Water: Free access to water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
The backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30 percent of the total body surface area. On the testing day, the rabbits received skin applications of the undiluted test material. After each application, the exposure site was covered by wrapping the trunk of the animal with an impervious plastic sheeting which was securely taped in place. This plastic wrap insured intimate contact of epidermis and test material. To further prevent oral ingestion of the test material, each animal was fitted with a light-weight flexible plastic collar which was worn throughout the observation period.

REMOVAL OF TEST SUBSTANCE
- Washing: no, all residual material was removed
Duration of exposure:
24 hours
Doses:
3000 and 10200 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
yes, concurrent no treatment
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, local skin reactions and abnormal behaviour were recorded during the observation period of 14 days.
- Necropsy of survivors performed: no
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:
> 10 200 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Pale red, definable erythema and slight edema were noted at the site of contact with the test material. These reactions subsided six days later, at which time dryness and desquamation were noted. The latter two reactions continued until the end of the observation period.
Body weight:
Normal.
Gross pathology:
Necropsy revealed hyperemia of lungs of animals in both groups and skin findings consistent with those previously described at clinical signs.

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 dermal toxicity study with DPM 3-800LC with male and female rabbits, performed equivalent to OECD 402 guideline, an LD50 > 10200 mg/kg bw was determined.
Executive summary:

The test substance DPM 3 -800LC was tested in an acute dermal toxicity study with male and female rabbits, performed equivalent to OECD 401 guideline. No deaths occurred up to highest tested concentration of 10200 mg/kg bodyweight.

Pale red, definable erythema and slight edema were noted at the site of contact with the test material. These reactions subsided six days later, at which time dryness and desquamation were noted. The latter two reactions continued until the end of the observation period.

Necropsy revealed hyperemia of lungs of animals in both groups and skin findings consistent with those previously described at clinical signs. Based on the results, an LD50 > 10200 mg/kg bodyweight was determined.