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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
Study period:
July - September 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Principles of method if other than guideline:
Standard acute method, applying 4 different doses to the clipped, intact abdominal skin
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-61-34 (ISOPAR E)
- Physical state: colorless liquid
- Substance type: colorless liquid
- Analytical purity:100% pure commercial product
- Impurities (identity and concentrations): free of impurities
- Other: aromatic odor

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.4 - 2.3 kg
- Housing: Throughout the observation period, the rabbits were housed individually in metal cages elevated above the droppings. Purina Rabbit Pellets and water were freely available at all times.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: abdominal skin
- Type of wrap if used: dental daming binder; wrapped with gauze and adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with sponge and warm water
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
100, 316, 1000, 3160 µL/kg bw
No. of animals per sex per dose:
4
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (daily)
- Frequency of observations and weighing: 0, 1, 4, 24 hours
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3.16 mL/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 - 2 500 mg/kg bw
Remarks on result:
other: Recalculated values based on the LD50 of 3.16 mL/kg bw; the range of LD50 is due to the range of density 0.71 -0.78 g/cm3.
Mortality:
No deaths at any dosage level.
Clinical signs:
Apart from 3 rabbits (2 of the 100 µL/kg dose group and one of the 3160 µL/kg dose group) which showed diarrhea for 2 to 4 days during the observation period, all animals seemed normal in appearance and behaviour throughout the study.
Body weight:
The final body weight of 2 of the animals which exhibited diarrhea showed a decrease from the initial body weight, while the remaining animals showed a normal body weight gain.
Gross pathology:
At autopsy, the 3 rabbits which showed diarrhea for 2 to 4 days during the observation period, exhibited pathological findings. One animals of the 100 µL/kg dose group showed paleness of the cortical portion of the kidneys. The other animals from the 100 µL/kg dose group showed an excessive amount of clear fluid in the peritoneal cavity and congested, pitted, tough kidneys. The rabbit of the high dose group showed inflammation of the intestines.
Other findings:
Dermal effects: Following removal of the binders at the end of the exposure period, the abdomens and binders were dry. At this time, the exposed skin areas of the animals showed a slight degree of erythema. Within an additional one to three days, the erythema had completely subsided in all animals. The low level animals showed no other signs of irritation during the reminder of the observation period. The high level animals showed slight or moderate desquamation during the final few days of the first week and during most of the second week. At termination, however, the exposed skin of the surviving animals was completely free of signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: other: CLP
Conclusions:
There is no need for classification.
Executive summary:

There is no need for classification.