Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1960-62
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, study containing basic data which suggests that basic scientific principles have been met. This is sufficient to judge the results reliable as a contribution to the understanding of the toxicity of this substance.

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1958
Report Date:
1958
Reference Type:
publication
Title:
Range finding toxicity data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel BS
Year:
1962
Bibliographic source:
Am Ind Hyg Ass J, 23, 95

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study pre-dates guidelines. Similar to one day cuff method of Draize (J Pharmac Exp Therap, 82, 377, 1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sample ref S182735. No further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ~2.5kg
- Age at study initiation: 3-5 months.
- Other: albino rabbits used.
- Diet: Rockland rabbit diet

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Fur removed from entire trunk area by clipping
- % coverage:
- Type of wrap if used: impervious plastic film (VINYLITE)

OTHER
- Animals immobilised during 24 hour exposure period.
Duration of exposure:
24 hours
Doses:
2.5, 5.0, 10, 20ml/kg
No. of animals per sex per dose:
2, 4, 2, 1 respectively.
Control animals:
other: no but a large number of other substances also tested which acted as reference materials.
Details on study design:
- Duration of observation period following administration: 14 days after wrap removed following 24 hour exposure.
Statistics:
The moving average method was used to calculate the LD50

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
7.1 mL/kg bw
Based on:
test mat.
Mortality:
All animals in top two dose groups died but none in lower two dose groups.
Clinical signs:
Marked erythema seen. Otherwise no signs in lower two dose groups.
Body weight:
5g/ml: Two animals showed normal weight gain, one little weight gain and one weight loss. 2.5ml/kg: One showed normal and one minimal weight gain.
Gross pathology:
High dose animal and one of the 10ml/kg animals showed internal and lung hemorrhage. Livers were congested and kidneys pale and possibly swollen.

Any other information on results incl. tables

Results:

Dose (ml/kg)

Mortality

Day of death

Average weight gain (g)

10

2/2

Both day 4

 

5

0/4

-          

135 (SD=163)

2.5

0/2

-          

100 (SD=130)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an acute dermal toxicity in rabbits in which key basic details were reported, an LD50 of 7100mg/kg was obtain. Exposure was under occluded conditions.

Synopsis

LD50=7100mg/kg