Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May-June 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is mentioned in the study report. Percutaneous administration of 1 g substance per rat took place.
The rats were tested in accordance with the method used in an older documented report (internal report number 77TM7 of 28 January 1977)
GLP compliance:
no
Remarks:
The study was conducted prior to the requirement for GLP for such studies
Test type:
other: Percutaneous administration of 1 g substance per rat took place.
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
The material was supplied by Dr P.A. Wilkinson (Greenford) and was stored at 4C before use. It is an intermediate in the synthesis of ceftazidime.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
(SDG)
Sex:
male
Details on test animals and environmental conditions:
Male SDG rats weighing 290 to 292 were used. They were obtained from the Glaxo Group Research Ltd., breeding unit (Harefield). The rats were housed singly.

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
7 day observation period
Doses:
A dose of 1 g/rat was used throughout. (3.4 g/kg body weight)
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 400 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
No signs of local or systemic effects toxity were shown.
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
No irritation (erythema or oedema) was observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
"**1132/4 DMF" has a low order of percutaneous toxicity in the rat with values greater than 3.4 g/kg bw.
Executive summary:

Three male SDGrats were percutaneously exposed to 1 kg/rat of 1132/4 DMF to determine acute toxicity and irritation through the dermal route. There were no mortalities and no local or systemic toxicity was observed. Finally, the substance was not found to be irritant to skin.