Registration Dossier

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: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
other: acute dermal toxicity study
GLP compliance:
no
Test type:
other: acute dermal toxicity study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2-methylene-bis-(4-methyl-6-tertiary-butyl phenol)

Test animals

Species:
rabbit
Strain:
other: Albino rabbit (no additional data given)
Sex:
male

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5 males per dose
Control animals:
not required

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality and clinical signs observed during the study

Any other information on results incl. tables

Mortality: none during the study (0/5)

Skin irritation: not observed during the study

Clinical signs: not observed during the study

Gross autopsy: normal

Applicant's summary and conclusion