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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ortho-Toluene, ethoxylated and propoxylated
- purity: >= 99%

- Composition of test material, percentage of components: Propylene oxide (100%)
- Lot/batch No.: QC 28080735
- Storage condition of test material: room temperature in the dark, over silica gel

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS:
- Source: RCC Ltd Laboratory Animal Services, Switzerland
- Age: 8 to 10 weeks (males); 12-14 (females)
- Weight at study initiation: animals of comparable weight
- Group size: single housing

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION:
- Area covered: approx 10% of total body surface
- application volume: 1.90 mL/kg
Duration of exposure:
24 hours
Doses:
single dose: 2000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
During and after exposure, animals were observed for signs of toxicity several times on the day of application; at least once each workday for 14 days. At the end of the study, all animals were killed and subject to gross necropsy.

In addition to the standard observations blood methemoglobin levels were examined on the day prior to application and immediately after removal of the bandage.Methemoglobin was determined using a hemoximeter.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths during the study.
Clinical signs:
No signs of systemic toxicity and no local effects.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities noted at necropsy
Other findings:
Minimal levels of methemoglobin were observed one day before application in one male
(0.3%) and one female (0.4%).
The blood samples taken immediately after removal of the bandage showed low levels of
methemoglobin (up to 1.5 %) in 9 animals. The mean value was 0.84%.
This indicates a slight increase of methemoglobin formation in the blood by the treatment with
2000 mg/kg body weight of the test substance.

Applicant's summary and conclusion

Conclusions:
The acute dermal median lethal does (LD50) was found to be greater than 2000 mg/kg bw in male and female rats. The test substance treatment induced a small increase in methemoglobin levels in the blood as compared to the pretreatment levels.