Registration Dossier

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: Study was conducted in accordance to GLP and OECD guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylidynetrimethanol, ethoxylated
EC Number:
500-110-3
EC Name:
Propylidynetrimethanol, ethoxylated
Cas Number:
50586-59-9
Molecular formula:
C3H5(CH2O(C2H4O)nH) sum of n: >1 - <6.5 mol EO
IUPAC Name:
Propylidynetrimethanol, ethoxylated
Details on test material:
Propylidenetrimethanol, ethoxylated mw 356; colourless liquid; content of test item: 100 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan GmbH, Horst, netherlands
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation:283 g - 297 g (male); 215 g - 227 g (female)
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn skin
- % coverage: approx. 10% of the total body surface area

REMOVAL OF TEST SUBSTANCE
After the 24-hour contact period, treated skin and surrounding hair wiped with water using soap

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths
Clinical signs:
No signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period
Gross pathology:
No abnormalities were noted on necropsy

Applicant's summary and conclusion

Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Wistar rat was found to be greater than 2000 mg/kg bodyweight.