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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Full details not in report. Numbers per dose = 2 and doses above limit dose used.
Principles of method if other than guideline:
Pre guideline study nevertheless fullfills the modern requirements.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Polymethylene Polyphenylisocyanate (PAPI)
- Physical state: dark, viscous, oily liquid
- Analytical purity: pure, no further information

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean body weight at study initiation: 2215-3180 g
- Housing: single
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 3 inch2 (19.35 cm2) in case of abraded skin
- Preparation of test site: The dorsal skin was prepared for treatment by closely clipping of the hair with an electric clipper in 2 rabbits (1 male and 1 female) per group. In addition, the skin of the rest of 2 rabbits per group was abraded by producing shallow incisions with a scalpel blade. The animals were confined in immobilising holders for 24 hours with their backs covered in rubberised cloth.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with lukewarm water
- Time after start of exposure: 24 hr


Duration of exposure:
24 hr
Doses:
2500, 3900, 6000 and 9400 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for clinical signs and dermal irritation. Body weights were obtained for each animal at the end of the experiment.
- Necropsy of survivors performed: yes. All animals were sacrificed with air embolization.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 400 mg/kg bw
Mortality:
No mortalities were observed.
Clinical signs:
All the animals appeared normal throughout the 14 days observation period with the exception of dermal irritation.
Body weight:
All animals showed either a body weight gain, or maintained body weight during the study, with the exception of 3 showing a slight weight loss unrelated to application of the test substance.
Gross pathology:
No substance- related abnormalities were observed. Sub-endocardial haemorrhages, apparently dose related observed were of questionable significance due to sacrifice of animals by air embolisation.
Other findings:
Dermal irritation: The irritation noted was slight in all instances. The slight erytherma produced initially at all dosage levels was negative after seven
days. All animals at all dosage levels did exhibit a slight coriaceousness which in most instances continued throughout the 14-day observation period. Transient atonia was observed in a few animals at the three high dosage levels; however, this again was slight in nature. One animal at the highest dosage level exhibited slight edema during the first and second days of the study. There was no desquamation nor fissuring noted with this
compound.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Criteria used for interpretation of results: EU