Registration Dossier

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: Basic data given: comparable to standards
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data List V
Author:
Smyth H F et al
Year:
1954
Bibliographic source:
Arch. ind. Hyg. occup. Med., 10, 61–68

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: one-day cutt method of Draize
GLP compliance:
no
Remarks:
study performed before implementation of GLP
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: New Zealand giant albino
Sex:
male
Details on test animals and environmental conditions:
Weight: 2.5 -3.5 kg

Administration / exposure

Type of coverage:
occlusive
Details on dermal exposure:
The fur is closely clipped over the entire trunk, and the dose, retained beneath an impervious plaster film, contacts abour 1/10 of the body surface. Dosages greater than 20 mL per Kg of bw connnot be retained in contact with the skin. After 24 hours contact the film is removed, and mortality is considered complete after 14 additional days.
Duration of exposure:
24 hours
Doses:
no data
No. of animals per sex per dose:
4 males
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 060 mg/kg bw
Based on:
not specified
95% CL:
630 - 1 790
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
On the basis of the results obtained after a single dermal administration, the dermal LD50 of styrene oxide was determined to be 1060 mg/kg bw.
Executive summary:

In an acute dermal toxicity study using the one-day cutt method of Draize groups of four male New Zealand giant albino rabbits were exposed to the closely clipped fur to 1/10 of the body surface. The dose retained beneath an impervious plaster film for 24 hours. Mortality was considered complete after additional 14 days.

The dermal LD50 Styrene Oxide was determined to be 1060 mg/kg bw (95% C.I. 630 - 1790).