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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test type:
other: acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethane- 1,2-diol, propoxylated
EC Number:
500-078-0
EC Name:
Ethane- 1,2-diol, propoxylated
Cas Number:
31923-84-9
Molecular formula:
HO(C3H6O)nC2H4(C3H6)nOH sum of n: >1 - <4.5 mol PO
IUPAC Name:
Ethane-1,2-diol, propoxylated
Details on test material:
- Physical state: liquid
- Content: 100%
- molecular weight: approx. 235

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
none: limit test

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
not influenced by treatment
Gross pathology:
no noticable gross pathological findings

Any other information on results incl. tables

Dose-response summary

Sex          Dose mg/kg bw/day       Toxicological result*       Occurrence of signs       Time of death       Mortality [%]

males       2000                              0 / 0 / 5                           --                                  --                        0

females    2000                              0 / 0 / 5                           --                                  --                        0

*: number of animals which died spontaneously and/or were sacrificed in moribund state / number of animals with signs of toxicity / total number of animals used per group

Additional detailed tables are attached below under 'Attached background material'.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute dermal toxicity is low with a LD50 value exceeding 2000 mg/kg bw in rats.