Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to accepted scientific standards at time of performance. Sufficiently documented and reported.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Repeated dermal application of test material
GLP compliance:
no
Test type:
other: dermal application
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hostapur SAS 60

- Physical state: pasty
- Analytical purity: 60%
- Composition of test material, percentage of components: 60% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: 1974-09-03
- Lot/batch No.: no data
- Expiration date of the lot/batch: 1976-10-01
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: in darkness at room temperature
- Other:

Test animals

Species:
mouse
Strain:
CD-1
Sex:
female
Details on test animals and environmental conditions:
see section 7.5.2 Repeated dose toxicity: dermal

Administration / exposure

Type of coverage:
open
Vehicle:
water
Details on dermal exposure:
see section 7.5.2 Repeated dose toxicity: dermal
Duration of exposure:
see section 7.5.2 Repeated dose toxicity: dermal
Doses:
0.1 mL of up to 32% (w/v) per mouse per day
No. of animals per sex per dose:
25
Control animals:
yes
Details on study design:
see section 7.5.2 Repeated dose toxicity: dermal

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: calculated
Mortality:
No mortality
Clinical signs:
see section 7.5.2 Repeated dose toxicity: dermal
Body weight:
see section 7.5.2 Repeated dose toxicity: dermal
Gross pathology:
see section 7.5.2 Repeated dose toxicity: dermal
Other findings:
see section 7.5.2 Repeated dose toxicity: dermal

Any other information on results incl. tables

see section 7.5.2 Repeated dose toxicity: dermal

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Repeated dermal application on mice of test material solutions as high as 32 % (w/v), 5 days per week for 4 weeks resulted neither in mortality nor
substance related systemic toxicity. The acute dermal toxicity of the test material is therefore calculated to be gretaer 2000 mg/kg body weight.
Executive summary:

see section 7.5.2 Repeated dose toxicity: dermal