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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:
weight of evidence
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study protocol is poorly documented.
Justification for type of information:
This information is in the dossier in support of the RA of the key study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal toxicity test with rabbits. Survival and clinical observations were recorded. A gross pathology was conducted.
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acryloid HF-422 (DBPP - polymer)
IUPAC Name:
Acryloid HF-422 (DBPP - polymer)
Constituent 2
Chemical structure
Reference substance name:
Dibutyl phenyl phosphate
EC Number:
219-772-7
EC Name:
Dibutyl phenyl phosphate
Cas Number:
2528-36-1
Molecular formula:
C14H23O4P
IUPAC Name:
dibutyl phenyl phosphate
Details on test material:
Acryloid HF-422 (70.8% dibutylphenylphosphate and 29.2% n-butylmethacrylate polymer)

Test animals

Species:
rabbit
Strain:
other: New Zealand
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
dosage: 2000 mg/kg bw
No. of animals per sex per dose:
10 animals: 5 males and 5 females
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality:
male: 0/5
female: 0/5
Clinical signs:
Six animals had dry and crusty skin in the treatment area. The remaining animals appeared normal.
Gross pathology:
Three animals had necrotic spots on their livers. One animal had white sediment in one kidney. Six animals were not remarkable.

Applicant's summary and conclusion