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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.