Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984/03/01-1984/03/15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to OECD Guideline 402: Acute Dermal Toxicity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Used 3 male and 3 female rabbits instead of recommended 5 for each sex; occlusive patch used
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland, Inc.
- Sex: male (3), female (3)
- Age at study initiation: appox. 19 weeks
- Weight at study initiation: 2,99-3.61 kg
- Housing: Individually
- Diet (e.g. ad libitum): Purina certified rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 52 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-71
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal surface
- Type of wrap if used: gauze patch covered with a plastic sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water and paper towels
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3160 mg/kg
- Concentration (if solution): Assumed to be 100%; density of 0.8578 g/ml
- Constant volume or concentration used: yes
Duration of exposure:
24 hrs
Doses:
one dose: 3160 mg/kg
volume: 11-13 ml
No. of animals per sex per dose:
3 males, 3 females
Control animals:
no
Details on study design:
SCORING SYSTEM: Draize scale
- Duration of observation period following administration: 2, 4, 24 hrs after dosing and once per day thereafter for 14 days
- Dermal response observations: 24 hrs, 3, 7, 10, and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Statistics:
The mean and standard deviations for the body weights and body weight changes were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
There were no animal deaths prior to study termination.
Clinical signs:
Overall low incidence of clinical in-life observations.
-Most frequently noticed: desquamation, atonia, leathery skin, and eschar. At the termination of the study all animals exhibited desquamation.
-Low Incidences: soft stool and small amount of stool, a single incidence of occular discharge and alopecia on the abdomen.
Body weight:
-4 of 6 test animals showed an overall increase in body weight during the 14 day test period.
Gross pathology:
All animals displayed very slight to well-defined erythema from day 0 to day 7. By day 14, only two animals still showed erythema; one having a very slight grade noted. Many animals exhibited very slight edema in a similar time frame.

Desquamation (6 animals), atonia (2 animals), leathery skin (2 animals), and eschar (1 animal) were noted through out the observational time period. At the termination of the study all animals exhibited desquamation.

Two animals were noted as being hyperactive and having a red nasal discharge after dosing. There was a single incidence of slight vocalization following dosing.
Other findings:
GROSS POSTMORTEM EXAMINATION
Alopecia for 1 animal (abdominal).
Severe erythema for 1 animal at the dosing site.
Desquamation for all animals at the dosing site.

Any other information on results incl. tables

Summary of other acute dermal toxicity studies.

End Point Study Reference  
REACH requirement IUCLID Section Study Name Data Waiving Waiving Justification Species Study Result Type Test Guideline/Qualifier Test Guideline/Guideline Test Guideline/Deviations Reliability Rational For Reliability GLP Compliance Test Materials/Identity Study Result Reference Type Reference Author Reference Year Reference Title Bibliographic Source Testing Laboratory Reference Report No. Owner Company Company Study No. Report Date Data access
8.5.3 Acute toxicity, dermal route 7.2.3 Acute percutaneous toxicity rat Experimental result According to  Noakes, D.N., and Sanderson, D.M. (1969). A method for determining the dermal toxicity of pesticides. Br. J. Industr. Med.,26, 59-64.  2 Summary only of study. No data     Shellsol A LD50 > 4 ml/kg  Study report Coombs, AD, Blair, D, Doak, SM, Carter, BI 1977 The Acute Toxicity of Shellsol A HSPA0692 Sittingbourne Research Centre M(T)-1-77 Shell Chemicals Europe BV June, 1977 yes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 > 3160 mg/kg based on these data, MRD-83-208 is not classified under EU requirements for dangerous substances and preparations. MRD-83-208 is also not classified under GHS guidelines.
Executive summary:

Three male and female rabbits were exposed to MRD-83 -208 for 24 hrs via an occluded patch. Dermal evaluations occurred at 24 hrs post patch removal and on days 3, 7, 10, 14. Exposure had no affect on viability; all animals survived the exposure. It is concluded that the LD50 in this situation is greater than 3160 mg/kg. MRD-83 -208 is not classified under EU dangerous substances and preparations guidelines. MRD-83 -208 is also not classified under GHS guidelines.