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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MDR-81-20
- Physical state: clear liquid
- Other: specific gravity 0.954

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Inc.
- Age at study initiation: young adults
- Weight at study initiation: males (2.8 - 3.4 kg) female (3.2 - 3.9 kg)
- Fasting period before study:
- Housing: individually
- Diet (e.g. ad libitum): Purina rabbit chow ad libitum,
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 45 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): monitored daily
- 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 and ventral surface and sides from scapular to pelvic area
- % coverage: at least 20%
- Type of wrap if used: occluded; 8-ply gauze wrapped in an impervious plastic sleeve sealed with masking tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 200, 794, 3160 mg/kg body weight
- Concentration (if solution): used as supplied
- Constant volume or concentration used: no


Duration of exposure:
24 hours.
Doses:
50, 200, 794 and 3160 mg/kg body weight
No. of animals per sex per dose:
2 males and 2 females per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1, 2, and 4 hours after dosing and daily thereafter for 14 d.
- Frequency of observations and weighing: x2 daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal response
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
All animals survived the study; mortality rate 0 %.
Clinical signs:
Animals in the 50 and 200 mg/kg dose levels generally exhibited barely perceptible erythema at 24 hours and day 3 post exposure. Most animals in the 794 mg/kg dose level exhibited very slight or well-defined erythema at 24 hours and day 3 post exposure. In the 3160 mg/kg dose level, very slight to severe erythema was seen in all animals at 24 hours and 3 days post exposure; two animals continued to exhibit very slight erythema on day 7 but no signs of dermal irritation were observed subsequently. Most animals exhibited nasal discharge during the 14 day post exposure period. One or two animals in the 50, 200 and 3160 mg/kg groups exhibited fecal staining of the fur.
Body weight:
Most animals which received doses of 50, 200 or 794 mg/kg exhibited weight gains at both day 7 and day 14 post exposure. At the 3160 mg/kg dose, one animal gained weight at day 7 while the others at that dose gain weight at day 7 and day 14.
Gross pathology:
Postmortem observations at termination of the study revealed findings similar to those seen in control animals killed by carbon dioxide inhalation or were considered unrelated to administration of the test material.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
All animals survived.
Executive summary:

In this study, rabbits were exposed to DTDP at doses of 50, 200, 794 and 3160 mg/kg body weight for 24 hours via occluded dermal contact and evaluated in the methods of Draize. Dermal assessment occurred at 1, 2, and 4 hours and once daily thereafter for 14 days post exposure un-wrapping. Every animal survived the exposure. Dermal responses were generally slight with the intensity and duration of the response occurring in a dose-related pattern. Animals in the 50 and 200 mg/kg dose groups generally exhibited barely perceptible erythema in response to exposure. Most animals in the 794 mg/kg dose group exhibited very slight or well-defined erythema at 24 hours, but were free of any dermal irritation by day 3 post exposure un-wrapping. All animals in the 3160 mg/kg dose group exhibited erythema ranging in severity from very slight to severe at 24 hours and on 3 days post exposure un-wrapping. All signs of dermal irritation were absent by day 14. It is concluded that the LD50 is greater than 3160 mg/kg.