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: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 402.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentaerythritol, propoxylated
EC Number:
500-030-9
EC Name:
Pentaerythritol, propoxylated
Cas Number:
9051-49-4
Molecular formula:
(C3 H6 O)n (C3 H6 O)m (C3 H6 O)x (C3 H6 O)y C5 H12 O4 1 < (n + m + x + y) < 8.5
IUPAC Name:
2,2-bis(hydroxymethyl)propane-1,3-diol; 3-[3-(3-hydroxypropoxy)-2,2-bis[(3-hydroxypropoxy)methyl]propoxy]propan-1-ol
Details on test material:
Pentaerythritol, propoxylated, (Molecular weight Mn = 420 g/mole)
LotNo. 0024
Storage: Room Temperature in the dark.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were neither deaths recorded.
Clinical signs:
There were no signs of systemic toxicity recorded.
Body weight:
Animals showed expected gains in bodyw eight over the study period except for three females which showed a slight bodyweight loss over the first week of the study and one female which showed no gain in bodyweight over this period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test material was found to be greater than 2000 mg/kg bodyweight.