Glycerol, propoxylated

Acute Toxicity: dermal

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

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

Test material information

Constituent 1

Reference substance name:

Glycerol, propoxylated

EC Number:

500-044-5

EC Name:

Glycerol, propoxylated

Cas Number:

25791-96-2

Molecular formula:

(C3 H6 O)n (C3 H6 O)n (C3 H6 O)n C3 H8 O3 n=>1-<6.5 mol PO

IUPAC Name:

alpha, alpha’, alpha’’-1,2,3-propanetriyltris[w-hydroxypoly(oxy-methyl-1,2-ethanediyl)]

Details on test material:

Test substance: Propoxylated glycerol mw 300. Purity 99.98% colourless viscous liquid.
Purity: 99.98%, Contains 200 ppm antioxidant.
Batch No: 0133759A

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Manston, Kent, UK
- Age at study initiation: 10-14 weeks
- Weight at study initiation: males 235-264g; females 212-233g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: undiluted

Details on dermal exposure:

TEST SITE
- Area of exposure: Shorn skin
- % coverage: 10% of total body surface
- Type of wrap if used: Aluminum foil with a double layer of self adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled Water
- Time after start of exposure: 24 hour

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and overt signs of toxicity were recorded at ½, 1, 2 and 4 hours after dosing and daily for 14 days. Bodyweights were recorded on the day of dosing and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: At the end of the study all animals were subject to gross necropsy, macroscopic abnormalities were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No signs of systemic toxicity or local irritation. All rats gained in body weight over the 14 day observation period.

Gross pathology:

Unremarkable.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The rat dermal LD50 for this glycerine/propylene oxide adduct mw 300 is >2000 mg/kg. No adverse effects were observed at this dose level.